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Findings register (62)
| Finding # | Classification | Description | Linked actions | |
|---|---|---|---|---|
| 1.1 | Major | 1.1 DATA MANAGEMENT — DATA MANAGEMENT- The Computerized Systems Periodic Activities Schedule (DIRA schedule) was deficient in that: a) Although 56 equipment assessments were planned, only four had been completed at the time of inspection. No documented status update or gap analysis was available to demonstrate completion or identify outstanding assessments. b) Although a risk assessment document had been prepared for computerized systems, there was no assurance that it included all relevant equipment, nor was it utilized to support risk-based prioritization of activities. c) Certain equipment with GxP data relevance, including Rynan equipment used in the Prednisone area for entry of batch numbers and expiry dates, was not included in the schedule. d) Recommendations arising from system capability assessments (including controls for user account management and password robustness) had also not been implemented at the time of inspection, thereby weakening established data integrity controls. Ref No: PIC/S Guide to Good Manufacturing Practice PE 009-17 (Part I), Chapter 1 paragraphs 1.4(iv), 1.4(viii), 1.12 1.13 and Chapter 4; WHO TRS No. 986 Annex 2, paragraphs 1.8 1.9, 15.1 15.9 |
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| 1.2 | Major | 1.2 DIRA - Empower Systems — The Data Integrity Risk Assessment (DIRA) protocol for the Empower system was inadequate in that the system was operating on Version 3.7 despite the availability of a later version (3.10). No documented assessment had been conducted to evaluate the impact of system upgrades or to determine the need for migration to maintain system suitability and data integrity. This indicates deficiencies in lifecycle management and change control for computerized systems. Ref No: PIC/S Guide to Good Manufacturing Practice PE 009 17 (Part I), paragraphs 1.4(xii xiii), 4.3; WHO TRS No. 986 Annex 2, paragraphs 1.4(n), 4.4. |
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| 1.3 | Major | 1.3 DIRA V Blender — The Data Integrity Risk Assessment conducted for the V Blender identified risks and defined mitigation measures; however, these recommendations had not been implemented at the time of inspection. This indicates ineffective execution of quality risk management outcomes and failure to ensure ongoing control of systems impacting GxP data. Ref No: PIC/S Guide to Good Manufacturing Practice PE 009 17 (Part I), paragraphs 1.4(xiv), 1.12 1.13; WHO TRS No.986 Annex 2, paragraphs 1.9, 4.5. |
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| 1.4 | Major | 1.4 DIRA Program — A comprehensive Data Integrity Risk Assessment programme was not in place. DIRAs had not been conducted for certain computerized systems, including LCO HMIs and the SAP system used for raw material dispensing. The overall framework was ineffective due to incomplete coverage of systems, absence of risk-based prioritization and failure to implement identified mitigation measures, thereby potentially compromising the integrity, reliability and security of GxP data. Ref No: PIC/S Guide to Good Manufacturing Practice PE 009 17 (Part I), paragraphs 1.1, 1.4(viii), 1.12; WHO TRS No.986 Annex 2, paragraphs 1.1, 1.8 1.9. |
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| 1.5 | Major | 1.5 Secondary Packing — During secondary packing of Rhineton batch BTG0879A, the following observations were identified: a) The batch number was entered by the operator into the system and verified by QA and the pharmacist; however, no provision was made for the operator’s signature. b) Upon completion of the leak test, the results were generated; however, the timestamp on the printout was incorrect, indicating inadequate synchronization between the equipment and the standard time. c) In addition, the leak test was not recorded in the Batch Manufacturing Record. d) HMI 2450-01-41-100, used on Packing Line 6 for labelling and entry of batch details, was not subject to access control. e) The HMI used for inputting batch and expiry date information for primary packaging of Prednisone Tablets with BN: BTH0143A was not access controlled which violated data integrity, as the absence of access restrictions allows unauthorized changes. Ref No: PIC/S Guide to Good Manufacturing Practice PE 009-17 (Part I), Chapter 4 paragraphs 4.7 4.9, 4.20; WHO TRS No. 986 Annex 2, paragraphs 15.1, 15.8 15.9. |
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| 1.6 | Major | 1.6 Management of Data Backup — Management of data back-up was deficient in that; a) SOP023472, which defined data backup for standalone systems, stated that monthly back-ups shall be done on the 1st day of the current month until the last day of the current month. The statement was ambiguous and did not clarify the actual back up month. SOP023472 stipulated that monthly backups were performed from the 1st day of the current month until the last day of the same month; however, the statement was ambiguous and did not clearly define the specific backup month. b) The standalone system data were backed up on hard drives; however, the storage capacity of the hard drives was not specified in the SOP. c) The company indicated that the hard drives had a storage capacity of four (04) terabytes, however, no documented assessment was performed to verify that the storage capacity was adequate to support routine data backup requirements to prevent potential data overwriting. d) SOP023441 for management of network-connected systems did not mention that the supplier would notify the laboratory when updates on the Empower system would be recommended. e) Furthermore, although the Head of Quality indicated that data are stored at the Centurion office, this requirement is not documented in the SOP. Ref No: PIC/S Guide to Good Manufacturing Practice PE 009 17 (Part I), Chapter 4 paragraphs 4.1, 4.10 4.11; WHO TRS No. 986 Annex 2, paragraphs 15.1, 15.9. |
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| 2.1 | Major | 2.1 Personnel — PERSONNEL- The site organogram (Annexure 8, Version 43), approved on 25 September 2025, was deficient in that: a) The Responsible Pharmacist did not report directly to the Chief Executive Officer; instead, they reported to the Site Quality Head, who was not a pharmacist. b) The site organogram did not demonstrate appropriate oversight of the production department by the Responsible Pharmacist (RP). c) The established reporting structure did not ensure that the RP held sufficient authority, independence in decision-making, or effective control over manufacturing processes. d) The RP s ability to exercise independent oversight of product quality and regulatory compliance was not demonstrated by this organogram. Ref No: PIC/S Guide to Good Manufacturing Practice PE 009 17 (Part I), paragraphs 1.5, 2.3, 2.5 2.6; WHO TRS No. 986 Annex 2, paragraphs 1.2, 9.3. |
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| 2.2 | Major | 2.2 JD Site QA/QC Head — The job description for the Site Head QA/QC was identical to that of the Responsible Pharmacist, resulting in duplication of responsibilities and lack of clearly defined roles thereby creating ambiguity in accountability, authority and decision-making for quality-related activities and the effective functioning of the Pharmaceutical Quality System. | 1 | Edit Remove |
| 2.4 | Major | 2.4 Personnel resposible for Calibration — The two validation personnel who were responsible for calibration activities at the facility had no external or specialized training on calibration of equipment thus there was no there is no assurance that they possessed adequate skills and expertise to perform calibration activities in accordance with GMP requirements. Ref No: PIC/S Guide to Good Manufacturing Practice PE 009 17 (Part I), paragraphs 2.1, 2.10 2.11; WHO TRS No. 986 Annex 2, paragraph 10.1. |
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| 2.5 | Major | 2.5 Receiving Checklist — The receiving checklist documented the number of components to be sampled, as recorded by the receiving operator. However, no training records were available to confirm that the operator had been trained in the sampling method required to calculate the appropriate number of containers to be sampled, as outlined in SOP 023433, Raw Material Sampling, Version 13, effective 25 August 2025. Ref No: PIC/S Guide to Good Manufacturing Practice PE 009 17 (Part I), paragraphs 2.10 2.11, 5.19; WHO TRS No. 986 Annex 2, paragraphs 10.1 10.2. |
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| 2.6 | Major | 2.6 SOP036503 Pharmaceutical Resposibility — SOP036503 (Version 1.0), effective 10 March 2025, described the process for verification of pharmacist registration with the South African Pharmacy Council (SAPC) and the management of delegation of pharmaceutical responsibilities was deficient in that did not include verification of credentials for Pharmacist Assistants as they were involved in signing batch manufacturing records (BMRs). Ref No: PIC/S Guide to Good Manufacturing Practice PE 009 17 (Part I), paragraphs 2.1, 2.5 2.6; WHO TRS No. 986 Annex 2, paragraphs 9.2 9.3. |
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| 3.1 | Major | 3.1 Contaminination and Cross-contamination — CONTAMINATION AND CROSS-CONTAMINATION- The HDPE bottles used for primary packing of Prednisone were not cleaned prior to use. Consequently, the risk of contamination of the product from the packaging material could not be excluded. Ref No: PIC/S Guide to Good Manufacturing Practice PE 009-17 (Part I), Chapter 5 paragraphs 5.19, 5.21; WHO TRS No. 986 Annex 2, paragraphs 14.19 14.21 |
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| 3.2 | Major | 3.1 Contaminination and Cross-contamination — Furthermore, the vendor audit report Pharmapac, the supplier of HDPE bottles used for Prednisone following the audit conducted on 11 March 2025 confirmed that no cleaning or washing steps were included in the suppliers manufacturing process for the packaging components and the risk of contamination of the bottles could not be excluded. Ref No: PIC/S Guide to Good Manufacturing Practice PE 009-17 (Part I), paragraphs 1.4(vi), 5.27; WHO TRS No. 986 Annex 2, paragraphs 14.8, 14.19. |
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| 3.3 | Major | 3.1 Contaminination and Cross-contamination — The procedure for cleaning of sampling tools specified that Type A cleaning, which included wiping the sampling tool with a lint-free cloth, was performed between batches of the same molecule however there was no assurance that this procedure adequately removed trace residues of carry-over between batches, potentially affecting analytical accuracy or product quality. Consequently, the risk of cross-contamination between batches could be excluded. Ref No: PIC/S Guide to Good Manufacturing Practice PE 009 17 (Part I), paragraph 5.21; WHO TRS No. 986 Annex 2, paragraphs 5.21, 13.6. |
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| 3.4 | Major | 3.1 Contaminination and Cross-contamination — Visible powder residues were observed on the external surfaces of drums containing Phenobarbitone API in the High value drug store area, indicating inadequate cleaning and housekeeping practices, thereby presenting a risk of contamination and cross-contamination. Ref No: PIC/S Guide to Good Manufacturing Practice PE 009 17 (Part I), paragraph 3.1; WHO TRS No. 986 Annex 2, paragraphs 3.1, 12.7. |
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| 3.5 | Major | 3.1 Contaminination and Cross-contamination — During dispensing of Sodium Cyclamate (Batch No. RBT0385) for Painagone syrup (Batch No., BTH0036), the raw material was scooped outside the LAF into a polyethylene bag, and the possibility of contamination could not be excluded. Ref No: PIC/S Guide to Good Manufacturing Practice PE 009 17 (Part I), paragraphs 5.18 5.19; WHO TRS No. 986 Annex 2, paragraphs 12.26, 13.1. |
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| 3.6 | Major | 3.1 Contaminination and Cross-contamination — In addition, although the operator indicated that cleaning was performed between raw materials, visible residue (pink powder) was observed on the lint-free cloth used for cleaning, demonstrating that the prescribed Type B cleaning procedure was not effective in removing residues to an acceptable level posing a cross-contamination risk between materials. Ref No: PIC/S Guide to Good Manufacturing Practice PE 009 17 (Part I), paragraph 5.21; WHO TRS No. 986 Annex 2, paragraphs 13.6 13.8. |
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| 3.8 | Major | 3.1 Contaminination and Cross-contamination — Damage to the metal surfaces was observed on the internal surface of the mixing vessel in the LCO Mixing 02 area, and the potential for product contamination by metal fragments could not be ruled out. In addition, damage was identified on the metal base surface of the Rapid Mixer Granulator (RMG) located in Granulation Room 1. Ref No: PIC/S Guide to Good Manufacturing Practice PE 009 17 (Part I), paragraph 3.39; WHO TRS No. 986 Annex 2, paragraph 13.1. |
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| 3.9 | Major | 3.1 Contaminination and Cross-contamination — The design of the OSD manufacturing areas did not ensure effective control of contamination risks in that: a) Raw material entry points to multiple cubicles (e.g. Blending 01 and 04 and other several powder generating areas) were not provided with airlocks. b) Blending 03 utilized a single entry for both personnel and materials. c) The clean equipment store was maintained at a lower pressure relative to the adjacent corridor, which may result in ingress of contaminated air and compromise the cleanliness status of equipment intended for use in production. Ref No: PIC/S Guide to Good Manufacturing Practice PE 009 17 (Part I), paragraphs 3.6, 3.18 3.20; WHO TRS No. 986 Annex 2, paragraphs 12.2, 12.30. |
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| 3.10 | Major | 3.1 Contaminination and Cross-contamination — During the sifting of Furobe tablets, visible dust was observed. It was further noted that the dust extraction unit was undersized relative to the sifting equipment, resulting in insufficient capture velocity and ineffective removal of airborne particulates. Consequently, the extraction system was ineffective in controlling dust emissions. Ref No: PIC/S Guide to Good Manufacturing Practice PE 009 17 (Part I), paragraph 3.12; WHO TRS No. 986 Annex 2, paragraph 12.30. |
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| 3.11 | Major | 3.1 Contaminination and Cross-contamination — During sifting operations, the operator was observed manually scraping powder from the sides of the sifter using gloved hands. This practice posed contamination risk of the product due to the potential for glove damage and direct contact between exposed skin and the product. Ref No: PIC/S Guide to Good Manufacturing Practice PE 009 17 (Part I), paragraph 5.18; WHO TRS No. 986 Annex 2, paragraph 11.5. |
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| 3.12 | Major | 3.1 Contaminination and Cross-contamination — Lubricant used for punches and dies was stored and decanted in a non-controlled environment (engineering store/outdoor area) and subsequently transferred for use within a Grade D manufacturing area. This practice did not ensure adequate protection of the lubricant from environmental contaminants and presented a risk of introducing contaminants from an uncontrolled environment into a controlled area. Ref No: PIC/S Guide to Good Manufacturing Practice PE 009 17 (Part I), paragraphs 3.34, 5.19; WHO TRS No. 986 Annex 2, paragraph 14.3. |
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| 3.13 | Major | 3.1 Contaminination and Cross-contamination — Dedusting of the excipients dispensed from the warehouse dispensing area was not done on the RM when it was delivered in the Prednisone Facility MAL, and the risk of contamination could not be excluded as the pallet would’ve been unwrapped outside the classified MAL. | 1 | Edit Remove |
| 3.15 | Major | 3.1 Contaminination and Cross-contamination — In the High Value Store, where Prednisone API was stored, powder residues were observed on the surfaces of the containers, and the possibility of contamination could not be excluded. | 1 | Edit Remove |
| 3.16 | Major | 3.1 Contaminination and Cross-contamination — During the handling of Prednisone API, the container was enclosed in a brown bag and a plastic bag. The brown bag was cut open under the Laminar Airflow (LAF) unit, introducing a potential risk of contamination to the material. | 2 | Edit Remove |
| 3.17 | Major | 3.1 Contaminination and Cross-contamination — It was indicated that during receipt of pallets containing dispensed excipients for Prednisone tablets manufacture, the shrink wrap was removed. However, pallets were observed with shrink wrapping still present in the dispensing area, indicating that the wrapping was not removed at the time of receipt and a risk of contamination from outside could not be excluded. | 1 | Edit Remove |
| 3.18 | Major | 3.1 Contaminination and Cross-contamination — Dirty equipment with visible powder residues was observed stored in Wash Area 08 together with equipment designated as clean within the Prednisone Facility. This practice presents a risk of cross-contamination and may compromise the cleanliness status of equipment intended for use in production. | 1 | Edit Remove |
| 3.20 | Major | 3.1 Contaminination and Cross-contamination — The MAL door and the external access door of the Prednisone Facility were not interlocked, creating the possibility of the ingress, of unclassified air into the classified area. Consequently, the risk of contamination from an unclassified area to the classified manufacturing environment could not be excluded. | 1 | Edit Remove |
| 3.21 | Major | 3.1 Contaminination and Cross-contamination — The walls of the lift used for transferring bulk products to the OSD primary packaging area were observed to be dirty. In addition, the lift area was not controlled and had direct communication with the ISO 8 Tablets and Capsules Store, creating a potential risk of contamination. | 1 | Edit Remove |
| 3.23 | Major | 3.1 Contaminination and Cross-contamination — Traces of Painamol residue were observed on the equipment in the Past manufacturing area despite it being affixed with a Clean status label, indicating inadequate cleaning controls and creating a risk of cross-contamination between batches and/or products. | 1 | Edit Remove |
| 3.25 | Major | 3.1 Contaminination and Cross-contamination — Powder residue was observed on equipment designated as clean and stored within the Clean Equipment Store area. | 1 | Edit Remove |
| 3.26 | Major | 3.1 Contaminination and Cross-contamination — Containment strategy was deficient in that: a) A document on risk assessment for cross contamination was performed for the year 2024 to 2025, approved on 25 July 2025, did not have a document number, version number, and was not on the formal letter head of the company. b) The product matrix for the OSD was outlined based on the ADE; however, the ADE limits were referring to the patient and not the operator who will be exposed to the APIs during manufacturing. c) According to protocol no.: VPD/ EXP/032 For the airborne particles, product cross contamination approved on 27 January 2026 only one (01) settle plate would be placed in the room, however no risk assessment was done to determine the actual number of settle plates and their positions in the different processing rooms to ensure coverage of critical areas. d) In the acceptance criteria, there was no mention of air visualization by smoke test. e) Swabs for the gowning were not mentioned, only the scoring of 04 for probability of detection was mentioned. f) Furthermore, the location of the swabbing of the gowns was not determined. g) It was noted that the document reviewed did not have a document number, version number and was not on the formal letter head of the company. It was approved on 25 July 2025. Ref No: PIC/S Guide to Good Manufacturing Practice PE 009 17 (Part I), paragraphs 1.12 1.13, 4.1, 5.21; WHO TRS No.986 Annex 2, paragraphs 1.8 1.9, 15.1. |
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| 4.1 | Major | 4.1 Validation and Qualification — VALIDATION AND QUALIFICATION CLEANING VALIDATION CV done based on Painamol, Protocol no.: VPD/CV-P/034-00 approved on 06 February 2019 by the RP/ QA was deficient in that: a) The rationale for the micro limit of not greater than 25 cfu/ 4 inch2 was not provided. b) After each batch TML was tested however the acceptance criteria were not mentioned in the protocol. c) There was no matrix on the product manufactured and what the rationale was for choosing Painamol tablets as the worst-case product for the Cleaning Validation. d) The personnel indicated that this was chosen because Painamol contains gelatine which is prone to microbial proliferation however this was not documented. e) The RMG Machine was the only equipment mentioned, however other equipment that were used in other production areas e.g. V-blender, ribbon blender, etc. were not included. f) There was no subsequent continuous cleaning verification done since February 2019. The CV report with protocol no.: VPD/CV-P/034-00 was deficient in that: g) The 12-batch campaign applied to all products had no scientific rationale and it was only based on the CV for the Painamol where the 11-batch campaign was determined. h) According to the company folic acid tablets was the worst-case product in terms of solubility and difficult to clean and PDE however only 3 PV batches of folic acid were manufactured which limited the production of the folic acid to three batches. i) No CV was done to determine the campaign batches for all other products by using folic acid as the worst-case. j) According to the company folic acid tablets was the worst-case product in terms of solubility and difficult to clean, PDE however only 3 PV batches were manufactured which would limit the production of the folic acid to three batches and not twelve (12) batches PIC/S Guide to Good Manufacturing Practice, PE 009-17 (Annexes), 25 August 2023, Annex 15, section 10 |
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| 4.2 | Major | 4.2 General Cleaning Validation — GENERAL CV a) The cleaning validation matrix for the OSD with document no.: VPD/CV-C/001 version: 09 approved on 24 April 2025 listed other equipment such as the IPC containers, SS scoops, deduster, metal detector (chute), sifter, mill, polisher brush and counting machine however there was no scientific rationale as to why they were excluded as critical equipment that came in contact with the product b) It was observed that under related documents there was no reference made on which GMP guidelines were used to compile the CV protocol. c) The list of other equipment that were not in contact with the product, were not listed in the protocol even though they were in the same room. d) In the protocol there was a dose criterion acceptance criterion that was supposedly used to calculate the MACO, however the calculation formula was inadequate as it did not mention that that was the calculation formula for MACO. Furthermore, there was no list of abbreviations/ Acronyms and their definitions in the protocol. e) The unit of measure used in the protocol for surface area was inches which was not a unit of measure used in SA. f) Other acceptance criteria such as visually clean, MACO, 10 ppm (which is no longer an accepted criteria) and the acceptance criteria for the rinse water for testing the amount of folic acid API LOD were not included in the protocol. g) According to the CV Programme with document no.: SOP023406 version 4 effective 12 March 2021, CV shall be performed on the entire equipment train every 03 years however there was no schedule in place for CV executions. PIC/S Guide to Good Manufacturing Practice, PE 009-17 (Annexes), 25 August 2023, Annex 15, section 10 |
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| 4.3 | Major | 4.3 Clean Eqipment Hold time study — CLEAN EQUIPMENT HOLD TIME STUDY Protocol number: VPD/CV-P/019-00 approved 26 Nov 2013 was deficient in that: a) The appropriate number of batches, considering the characteristics of the materials and other relevant aspects were not outline in the protocol based on a risk-based approach. b) It was observed that there was not test performed on the rinse water used to remove the detergent. In the report there was a result of 100 cfu/ swab, and this was not mentioned under the acceptance criteria in the protocol. c) At the time of the study, the equipment matrix/ train was not defined. WHO Technical Report Series No. 992, 2015, General guidance on hold-time studies, Annex 4 |
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| 4.5 | Major | 4.5 Process Validation — PROCESS VALIDATION Protocol VPD/PV-P/138 for Betaprofen, approved on 26 August 2020, was found to have several deficiencies: a) Continued Process Verification (CPV) was not performed at the time of inspection. b) The process flow did not include identification of Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs). c) Blend uniformity was not performed routinely, despite being identified as a critical process parameter during process validation blending. d) Risk assessment was performed for process parameters; however, not all parameters were included (e.g., blending speed, material flow, compression speed and force, coating temperature). e) The sampling plan covered only the V-blender for blend uniformity; no sampling plan was established for coating. f) The equipment train included only the V-blender, compression machine, and coating pan, while other equipment and their qualification status were not documented g) During process validation for Furobe (Protocol VPD/PV-P/195, approved on 08 April 2026), a risk assessment of the different manufacturing processes and associated Critical Process Parameters (CPPs) was performed. However, drying was not included in the risk assessment, and consequently, the CPPs and CQAs for the drying process were not identified. h) Process validation had not been performed for the primary packaging process of patient-ready packs on Line 4. i) The manual packaging process for bulk containers (1000-count packs) on Line 6 had not been validated. j) During the compression of Prednisone (Batch No. BTH0145) in Compression Room 09, only the turret speed was controlled and recorded at 30 (specified range: 19 32). Although the feeder speed and compaction force were set on the machine at 45 and 8 9, respectively, these critical process parameters were not recorded. k) No metal detector was installed in the encapsulation area; consequently, metal detector checks were not performed during the encapsulation process. l) The CPPs for the Prednisone manufacturing process such as side belt speed, press roller pressure, conveyor speed, and cap feeder speed were not documented in the BPR. This directly impact container closure integrity, sealing consistency, and contamination control. PIC/S Guide to Good Manufacturing Practice, PE 009-17 (Annexes), 25 August 2023, Annex 15, section 5. |
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| 4.7 | Major | 4.7 Hold Time Studies — HOLD TIME STUDIES a) The in-process hold time study (VPD/PHT-P/036), completed on 09 December 2013 for Painamol tablets and blend (Batch No. 2548140), was not representative of the routine manufacturing process. The blend hold time size was 2kg whereas the routine process involved a drum of 100L (≈70kg). Similarly, compressed tablets were assessed at 6,000 units, while routine practice involves approximately 23,000 tablets per bucket. b) Risk assessment (RA) was not performed, and other critical factors such as headspace were not considered. WHO Technical Report Series No. 992, 2015, General guidance on hold-time studies, Annex 4 |
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| 4.8 | Major | 4.8 GLASSWARE — GLASSWARE a) The cleaning study validation report QC/CV-R/359, approved on 10/04/2025 under protocol QC/CV-P/359, was reviewed and found to have excluded certain glassware. Distillation tubes, glass lids used for moisture dishes, distillation flasks, weighing boats, crucible lids, solvent bottle lids, and the 3000 mL vessels were not included, and no rationale for their exclusion was provided. Moreover, while the lids were available in multiple sizes, the specific sizes were not documented b) In the cleaning study, loading patterns were not defined, and the drying procedure was not included. c) Additionally, the reference for the method used for preparing the standard was not provided d) Scratches were noted on certain glassware items in the reagent room, specifically a conical flask and a volumetric glass, indicating inadequacies in the glassware inspection process. e) Standard Operating Procedure SOP023420, version 5, outlined the process for calibrating volumetric glassware. However, calibration was not performed at the time of the inspection. PIC/S Guide to Good Manufacturing Practice, PE 009-17 (Annexes), 25 August 2023, Annex 15, section 10 |
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| 4.9 | Major | 4.9 Management of Columns — EQUIPMENT QUALIFICATION a) The dust extractors used in the blending area had not been qualified at the time of the inspection. b) In addition, the dust extractor used during the blending of Prednisone Batch No. BTH0146 was positioned at a considerable distance from the enclosed sifter. No documented justification or rationale was available to support the suitability of its location in relation to effective dust extraction during the process. c) No camera verification system was installed on Primary Packaging Line 3 (OSD) to automatically verify label information and barcode details during packaging operations, creating a risk that labelling errors may not be detected. d) No camera inspection system was installed on the LCO secondary packing lines, and no documented challenge testing had been performed to verify the effectiveness and reliability of packaging line controls. e) The refrigerator used for the storage of certain primary reference standards had neither been temperature mapped nor qualified. f) In Dispensing Booth 2, the operating range for the weighing balance was specified as 2.5 kg to 100 kg. However, during the dispensing of Ascorbic Acid, a raw material quantity of 1.9kg was weighed, which was below the validated operating range of the balance. g) The metal detector challenge test procedure was inadequate. The SOP required sensitivity adjustments until the detector rejected the ferrous, non-ferrous, and stainless-steel test pieces if initial rejection did not occur. This approach did not provide assurance of the metal detector's actual performance capability or its ability to consistently detect contaminants at the established sensitivity limits. h) The required metal detector challenge test, scheduled to be performed once per shift, was not conducted during the shift of 20 April 2026. i) Performance Qualification (PQ) for the horizontal autoclave (serial number ER-AS300-DD) was conducted using two trays for loading packs and one tray for loading bottles. However, during routine sterilization only one tray was used, and therefore the effectiveness of the sterilization process could not be assured. PIC/S Guide to Good Manufacturing Practice, PE 009-17 (Annexes), 25 August 2023, Annex 15, section 3 |
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| 4.10 | Major | 4.10 Equipment Qualification — (Full observation text not found in the inspection response document for this reference.) | 7 | Edit Remove |
| 4.11 | Major | 4.11 Temperature mapping Capsule store — Temperature Mapping of the Capsule Store was deficient in that: a) The protocol for periodic performance verification of Environmental Control System in the Capsule Storage Area Protocol no.: VPD/PPV-P/215 lacked details regarding the methodology and the schematic on the location of the data loggers to be used and the rationale for placing data loggers at those specific spots. b) There was no reference on which GMP Guideline was used to compile the protocol. c) The mapping report no.: VPD/PPV-R/215 approved on 30/05/2022 was deficient in that there was no rationale provided on why ten (10) loggers were used for the study and there was no reference on the GMP Guideline was used. d) The report indicated that the mapping was done in 03 consecutive days however there was no mention of the actual dates nor the season in which the mapping was performed e.g., Summer or Winter. e) Temperature mapping studies had not been performed for the room used to store Reference Standards (Under Test Room), resulting in a lack of documented evidence that storage conditions were consistently maintained within the specified temperature range required to preserve the integrity and quality of the reference standards. Ref: WHO Technical Report Series, No.961, 2011, Temperature mapping of storage areas, Supplement 8 |
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| 5.1 | Major | 5.1 Materials — MATERIALS 5.1 DEG & EG TESTING FOR EXCIPIENTS According to the RM Sampling SOP no.: 023432, for Propylene Glycol 400, Polyethylene Glycol, Glycerine and Polyoxyl 40 Hydrogen 100 % sampling was done for testing of DEG & EG impurities. However, Sorbitol which was also used as an excipient, was not tested for EG & DEG. Tests for diethylene glycol and ethylene glycol in liquid preparations for oral use- Working document QAS/23.922/rev4 17 July 2024 |
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| 5.2 | Major | 5.2 SCHEDULED MATERIAL MANAGEMENT — SCHEDULED MATERIAL MANAGEMENT a) The inventory management of controlled substances was found to be deficient as the stock reconciliation for Codeine Phosphate, batch number RBTG0246, did not balance between SAP, physical inventory, and the scheduled register. The physical quantity was 57.48 kg, while SAP and the register reflected 47.55 kg b) Furthermore, the scheduled register was not balanced on a quarterly basis as required, with balancing dates recorded only on 26 August 2025 and 13 January 2026. |
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| 5.3 | Major | 5.3 LUBRICANT — LUBRICANT a) The lubricant was not received with a Certificate of Analysis (COA), providing no assurance that it was food grade. Review of the Safety Data Sheet only indicated the product was Hydraulic Oil Fluid 68, manufactured by Sasol. b) Waste associated with scheduled material was not segregated and stored separately; it was staged in the Dirty Equipment Store. |
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| 1 | Other | 1 Premisis — PREMISES a) The primary packaging areas such as line 3 and 4 in the OSD area were observed to be in a poor state of repair, as evidenced by damaged floor covings on the packaging lines, as well as damaged and shedding locker seals in the second gowning area. These deficiencies may impair effective cleaning and maintenance practices and increase the risk of particulate contamination. b) The Secondary Packaging Area (OSD) was observed to have multiple facility and infrastructure deficiencies that could adversely affect the maintenance of a clean, controlled, and compliant manufacturing environment. The findings indicate deterioration of surfaces and building finishes, including peeling sealant on air grilles and ceilings, rust formation on ceiling sections, damaged coving, and floor cracks leading to the primary packaging area. c) In addition, evidence of potential water ingress was noted through water stains inside a light cover on secondary packaging line 1, with one light fitting partially detached from the ceiling. d) Positions for settle plates and the air sampler were not defined, identified, or visibly marked, resulting in a lack of standardized environmental monitoring locations in the production areas e.g. Dispensing booth 02. e) The condition and maintenance of facility surfaces and infrastructure in the production areas was deficient in that the Post-Staging Area (OSD) was found to have a damaged floor, while Mixing Room 2 exhibited peeling paint on the walls and damaged ceiling coving that was separating from the wall. f) Access to the change room was not controlled, as no access control mechanism was in place. g) Dust residue was observed inside Locker 27, and dust accumulation was noted on top of the lockers, indicating inadequate cleaning practices. h) One light fitting was not functional in the material store, indicating inadequate maintenance of the facility. i) Dirt accumulation was observed on the floor beneath the floor scale in the Primary Packaging Area, indicating that the area was not being cleaned on a regular basis. j) In addition, the SOP did not clearly define the cleaning requirements or specify the areas and equipment that cleaners are required to clean in the Primary Packaging Areas. k) The General Store Change Room did not have access control measures in place, resulting in unrestricted entry and increasing the risk of unauthorized access. In addition, area was not labelled. l) No cleaning logs were available for the First Change Room, Second Change Room, and personnel lockers. The absence of documented cleaning records does not provide assurance that routine cleaning activities were performed. m) The air grilles in the Change Rooms were not labelled. n) According to the company, the name of the Bulk Store which was used to store the punches and dies of Prednisone tablets was going to be changed, however there was no control change was initiated. Ref No: PIC/S Guide to Good Manufacturing Practice PE 009 17 (Part I), Chapter 3 |
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| 2 | Other | 2.Personnel Hygeine — PERSONNEL HYGIENE a) During the coating of Betaprofen, the operator was observed wearing overshoes that were worn and visibly dirty. There was no evidence to demonstrate that the overshoes had been replaced prior to the operation. Additionally, one leg of the overcoat was torn, exposing the underlying primary gown. b) Upon enquiry regarding gowning practices, the operator stated that only the overcoat had been changed, while the overshoes had not been replaced. c) Gowning and de-gowning pictorial instructions were not displayed in the General Store Change Room. In addition, SOP 023226 did not define the required gowning sequence resulting in inconsistent gowning practices. |
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| 3 | Other | 3 Documentation — DOCUMENTATION a) The batch number for the replaced vent filter for the RO tank was not recorded, and there was no assurance that this replacement was verified relative to the batch number of the vent filter that was on the box. b) During receiving, there was no process on how they deal with consignment that did not have a COA and when stock coming from international vendors were received in Receiving SOP 023477. c) The procedure for Waste Management SOP no.:030567 mentioned that all rejected schedule 5 or higher will be placed in a drum labelled with a PHARMACEUTICAL WASTE FOR DESTRUCTION and the pharmacist clarified that the sticker is only attached once approval is granted by SAHPRA and this was not mentioned in the SOP. d) The logbook for temperature and humidity, book number WH/013/2026, effective 06 January 2026, was not subject to version control and lacked approval signatures indicating inadequate document control practices. e) Temperature & RH logbook for capsule store, there were a few excursions. According to the SOP a deviation would only be raised when the excursions was more than 24 hrs and there was no rationale provided for this practice. f) During dispensing of Painagone syrup, the operator did change the sleeves before dispensing the next RM however 5.7.4 only referred to the gloves. g) Temperature and RH logbook for dispensing 2 was filled in daily, however pressure gauge readings were not recorded. h) The dispensing SOP indicated that Type A cleaning, involving wiping the dispensing tool with a lint-free cloth, should be performed between dispensing of excipients. However, during observation of dispensing activities, the dispensing scoop was handed to the runner to be cleaned in the wash bay after each excipient, which was not aligned with the SOP requirements. i) SOP023348 outlined routine checks for pipe integrity; however, the logbook (Form034752) was not adequately detailed. j) Type B cleaning checklist (Form034738) and Type A cleaning checklist (Form034767) completed during line opening were completed by the operator, who verified the activities by ticking. However, no documented evidence was available to confirm that the Pharmacist/QA verified the activities prior to signing. k) The door of the Quarantine Store was not labelled. l) Inventory management practices at the Prednisone Facility were found to be deficient with respect to FIFO principles, as multiple batches were simultaneously opened and partially weighed (RBTH0104 = 14.97, RBTH0018 = 3.25, RBTH0017 = 13.95). m) During the IPC for Rhineton Syrup batch: BTG0879A in the primary packing area, it was observed that weights recorded on the BMR were manually rounded. The electronic balance used for weighing has a resolution of 0.001g, and the true measured values were not recorded. n) There was no SOP for cleaning of the vacuum cleaner staged in the Primary Packaging Area of the Prednisone Facility. o)SOP038390, which described the issuance of raw materials to the OSD area, was found to be insufficiently detailed. While the site indicated that materials were received shrink-wrapped and transported in a closed truck, these requirements were not explicitly documented within the procedure. p) SOP 023247 referenced Type B cleaning; however, under the section describing the cleaning of rooms/cubicles, the list of items to be cleaned did not include the CG screen and return air grilles. q) Type A cleaning instructions required operators to wipe scoops and to "use PW when necessary." This instruction was not clearly defined and allowed for subjective interpretation by operators, resulting in potential inconsistencies in cleaning practices. r) The label affixed to the purified water container used for Type A cleaning in Dispensing Booth 2 did not include the "Prepared Date" and "Use By Date." s) The cleaning SOPs lacked sufficient detail to ensure the consistent and controlled execution of cleaning activities. Specifically, the procedures did not clearly differentiate between equipment that should be cleaned within the blending room and equipment that should be cleaned in the designated washing area. t) In addition, the procedure did not describe the requirements and controls for transferring equipment from the blending room to the washing area for cleaning. u) Post-cleaning checks were required to be performed for Buckets, IBCs, and pipes by the supervisor. However, labelling was inconsistent, with some labels signed and others unsigned. |
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| 4 | Other | 4 Annual Product Review — ANNUAL PRODUCT QUALITY REVIEW One of the criteria for doing the annual product review was based on the Product approval date (i.e. release date) where the first anniversary shall fall 12 months from the product approval date and thereafter every year, there was no rationale for tis criteria as the annual product review should start from the initial production date. |
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| 5 | Other | 5 Referrence Standards — REFERENECE STANDARDS a) The primary reference standard for the phenobarbitone reference standard was not available. b) According to the laboratory, they were to qualifying the working standard against a reference standard. They were doing the titration method to qualify the phenobarbitone working standard without any scientific rationale. c) Indent standard was not defined in the SOP. |
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| 6 | Other | 6 Good Quality Control Laboratory Practices — GOOD QUALITY CONTROL LABORATORY PRACTICES a) For Pyrocaps, the specification included moisture content to be NMT 8 % by KF method, and there was no desiccant in FP to control moisture, and it was store in a sample receipt room where RH was not monitored. b) Glassware cleaning was performed using a washing machine; however, the loading patterns were not displayed to ensure accurate positioning of the glassware. c) The procedure for washing pipettes was not sufficiently detailed. Specifically, the soaking time, soaking volume, and rinse time were not defined. d) In addition, the procedure did not include instructions for drying glassware. e) It was indicated that glassware was inspected before cleaning and after cleaning, and cracked glassware was recorded in a logbook. However, this practice was not documented in a formal procedure. f) Titrator - The electrode was stored in 2M LiCl solution; however, the required frequency for changing the storage solution was not defined. Long uncontrolled storage may result in precipitation, or degradation of the electrode junction, potentially leading to unreliable analytical results. g) The NaOH solution prepared in-house was used as a titrant for the standardization of KHP. However, the solution connected to the equipment was last prepared on 10 March 2026, and a defined use-by date was not assigned. |
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| 7 | Other | 7 Storage Areas — STORAGE AREAS a) Material Store in OSD Manufacturing Daily temperature and relative humidity (RH) monitoring records indicated that the RH reading recorded on 20/04/2026 at 07:52 was 68.9%, exceeding the established limit of 65%. Although personnel stated that the out-of-specification (OOS) condition had been reported to Engineering, there was no documented evidence of the notification, investigation, assessment, or corrective actions in the logbook or any associated records b) In-Process Store The inventory recorded in the stock logbook did not correlate with the physical stock present in the area. For example, the logbook indicated that one tank and six drums of Pyrocaps had been received and subsequently issued to Production; however, six drums were still physically present in the store at the time of inspection. This discrepancy indicates deficiencies in inventory control, material traceability, and stock reconciliation practices. c) Under Test Sample Room Temperature was monitored within the Under-Test Sample Room; however, relative humidity was not monitored, despite the storage of moisture-sensitive products, including Flustat Capsules and Pyrocaps Capsules. The absence of RH monitoring did not provide assurance that environmental conditions were maintained within suitable limits for the storage of moisture sensitive products. d) Post Staging Area. The RH data logger identified as 62211863 was configured with an alert limit of NMT 70% RH and an action limit of NMT 75% RH; however, no documented scientific or technical rationale was available to support the establishment of these limits. |
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| 8 | Other | 8 Purified Water System — PURIFIED WATER SYSTEM a) It was observed that the batch number of the RO tank, vent filter installed on 29/10/2025 according to the PW system maintenance sheet FORM035133, was not recorded and there was no assurance that this replacement was verified against the BN that was on the box in which the vent filter was. b) Slope assessment for the piping leading to the drain in the water system was not performed to ensure adequate drainage. c) Sampling for water was outlined in the LCO Block routine sampling schedule (Form 034667, version 5, effective 22/01/2026) which specified sampling point and frequency. The logbook made provision for weekly checks, however, the specific checks to be performed were not defined. d) SOP 023501 on Monitoring of Pharmaceutical Water Quality indicated that the sampling points were flushed with water prior to sampling, however the flush time or quantity of water to be flushed was not specified. e) Furthermore, the SOP specified that water samples must be tested within 24 hours, however the actual sampling time was not documented in the logbook. f) A container of purified water stored in a white bottle was observed without a Prepared Date and Discard/Use-By Date. The absence of this information did not provide assurance that the purified water was used within its approved holding time and quality limits, thereby increasing the risk of microbial contamination and the use of water of unsuitable quality during cleaning operations. |
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| 9 | Other | 9 HVAC — HVAC a) Differential pressure readings were recorded daily on Logbook 140-2026; however, no defined alert or action limits were established for the recorded DP values (limit: 50-250 pa), and these were not specified in SOP023591, which governed maintenance of AHUs. b) The HEPA filter integrity test report for AHU 03 indicated the use of Shell Odina EL oil as the challenge of aerosol; however, no Certificate of Conformance (CoC) was attached to provide assurance that the aerosol was suitable for use and did not promote microbial growth. c) Furthermore, critical test parameters, including scanning rate and scanning distance, were not recorded in the report, limiting the assurance of the adequacy of the integrity testing performed. d) Access to the LCO HVAC area was not controlled, which may pose a risk to system integrity. e) The damper settings AHU LO1 designated for primary packaging had shifted from their intended positions, and the dampers were neither covered nor locked to prevent unauthorized adjustment. f) Additionally, the incoming air inlet was not labeled, and the settings for the blue adjustment knob were not defined, indicating a lack of standardized control measures. Alert and action limits were not displayed on the system, limiting effective monitoring. Dispensing 2 g) No action and alert limits were displayed on PD Gauges. This observation was seen in most of the production areas including at the Prednisone Facility particularly at the Dispensing Area. h) According to the operator only three people were allowed however the Dispensing SOP no.: 023479 was not clear on the number of people to be in the dispensing booth. i) According to the labour record form 035373 there were inconsistencies regarding number of people in the cubicle. On 29/01/2026 there were 4 people in the room at 15:00. On 02/02/2026, there were 06 people in the room at 09:12. j) There were no action and alert limits for the pressure gauges displayed (limit: 50-250 pa) on AHU 3 and were not mentioned in SOP023591, the procedure for maintenance of AHUs. |
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| 10 | Other | 10 Compressed Air — COMPRESSED AIR a) Compressed air schematic diagram (DRG-OSD-CAPID-025, Rev 01) was not approved. b) The schematic diagram indicated various components of the compressed air system, including filters at point of use. Only filters in V-blender RM 62, Air Blowing 1 (UP 08), AB 2 (UP 13), and Equipment Wash (UP 14) were noted on the diagram. Filters for all other rooms were not indicated, and there was no assurance if they had filtered at the point of use. |
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| 11 | Other | 11 Microbiology Laboratory — MICROBIOLOGY LABORATORY a) Chemicals, such as barium chloride dihydrate, were noted with two different receiving dates, 20 March 2024 and 09/04/2024 compromising traceability of chemicals. b) SOP 023500 on Handling and Storage of Microbiological Media, Buffers, and Reagents specified that media must be inspected prior to use. However, in practice, inspection was only performed at the time of receipt. |
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| 12 | Other | 12 FBD Bags & Sieves — FBD BAGS & SIEVES a) Checks required on sieves included cleanliness, integrity, and drying, however, the logbook did not define the specific checks to be performed for integrity. b) The life cycle of the FBD bags was defined as to be used until unusable; however, the usage cycles were not established. c) The checks performed on the FBD bags were limited checking for holes and tearing, and other checks such as, seams, stitches and loose threads were not performed. d) FBD Bag G-Painamol-1 was observed with loose threads. |
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| 13 | Other | 13 Equipment — EQUIPMENT a) The calibration certificate for the dial indicator of the micrometer (1303481) with the calibration certificate number: DB 12805 was deficient in that there was no calibration date for the instrument. b) The equipment ID for the weighing scale was WHDSC013 on the dispensed material print-out however the equipment ID on the weighing scale was WH/DSP/SCL-012 displayed on the weighing scale display. The Pharmacist did not verify the equipment ID when verifying the amount weighed and dispensed. Dispensing 02 c) The dispensing scoop used during dispensing was identified as 1/100, whereas the equipment label indicated LD/01, reflecting inconsistent equipment identification and labelling practices. d) The clean status label affixed to scoop LD1/3 identified the equipment ID as "N/A" instead of the correct equipment identifier. e) SOP023356 titled Operation and cleaning procedure of the fixed storage vessels mentioned that clean status label should be completed after cleaning however holding tank 3000-04-09- 100 cleaned on the 02/02/2026 was noted to be without a status label. LCO SECONDARY PACKING f) Leak test apparatus 3500-09-67-100, qualified on 10 May 2024, was not subjected to routine calibration. TRANSFER PIPES g) The PW board displayed the dispensing date for the silicone transfer pipe. According to the supervisor, silicone pipes used for PW transfer were replaced based on the outcome of integrity testing. However, there was no documented procedure or evidence indicating that all silicone pipes across the processing cubicles were replaced simultaneously or according to a defined replacement schedule. h) Transfer pipes were dedicated and assigned unique identification numbers. However, the labelling method used on the pipes appeared susceptible to fading over time, which may compromise equipment identification and traceability. i) SOP No. 023348, Cleaning of Transfer Pipes, describes the cleaning procedure for reusable transfer pipes; however, it does not specify the removal and cleaning requirements for tri clover fittings. In addition, condensate was observed in transfer pipe CD/01/MT, which was reportedly cleaned on 27/01/2026. The presence of retained condensate may present a risk of microbial proliferation. MIXING 02 j) The vessel s viewing light was not functional, and a torch had to be used to inspect the interior. k) The rinsing procedure for the dip stick was not defined in the process. GRANULATION 3 l) During the sifting of Furobe tablets, The Teflon scoop used for transferring raw material onto the sifter was observed to have an uneven surface with humps which did not facilitate effective cleaning |
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| 14 | Other | 14 Post- Dispensing Staging Area — POST- DISPENSING STAGING AREA a) Some RM were shrink wrapped and others not and there was no rationale provided for this practice. For example, Painamol tablets BN: BTH0056 was not shrink wrapped. b) Betaprofen BN: BTH0062 was shrink wrapped and another batch BN: BTH0062 was not shrink wrapped. There was a total of 09 bags of the Ibuprofen API which were located at different locations and a separate pallet with the excipients was shrink wrapped. The possibility of mix up could not be excluded. c) Post-dispensed raw material for Prednisone manufacture was staged in the dispensing area. At the time of inspection, four batches were staged simultaneously, and the risk of product mix-ups could not be excluded |
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| 15 | Other | 15 Cleaning of the FBD Bag (Granulation 1) — CLEANING OF THE FBD BAG (GRANUALTION 1) a) The operator indicated that during cleaning, the FBD bag was dipped in F919 and hung for 30 minutes, then dipped in F10 and hung for 2 5 minutes, followed by rinsing with purified water until no foam remained. However, this process was not documented. b) During a demonstration of hanging the FBD bag on a stand for washing, it was noted that some of the fingers of the bag became tangled. This condition raises concerns regarding the effectiveness of the cleaning process, as entangled fingers may prevent thorough washing and rinsing, potentially leaving residues and compromise cleaning validation. |
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| 16 | Other | 16 Punches and Dies — PUNCHES AND DIES a) Lubricant was decanted into a container; however, the container was not labelled. This was also observed in the Prednisone Facility. b) Management practices for punches and dies were found to be deficient. Specifically, punches and dies (01 to 37) for Betaprofen were issued on 25 March 2026 for batch BTH0060. The batch was completed on 17 April 2026, and the next campaign batch commenced on 21 April 2026, indicating a gap in traceability and control over tooling between campaigns. c) The height gauge of the micrometer used in the OSD manufacturing area was not calibrated d) Height gauge used in the Prednisone facility had a certificate no.: DB12805 however, there was no calibration date on the calibration sticker. e) Four sets of punches and dies were available for Prednisone Tablets (Sets 62, 65, 39, and 40). Set 62 and 39 were incomplete; however, damaged punches and dies were not identified to ensure adequate and traceability of rotation of tooling |
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| 17 | Other | 17 QC equipment & Micro lab — QC EQUIPMENT a) For the Moisture Analyzer MO.003, the calibration certificate did not include a recalibration due date. In addition, the calibration status of the reference standard used was not recorded. b) Balance room - The mass pieces (ID B14642958, Certificate M24-845, calibrated on 23/07/2024 and valid until 2026) were available; however, the smaller mass pieces were not traceable as they were not affixed with identification labels. MICROBIOLOGY LABORATORY c) The balance used in the media preparation room was not labelled with an identification number, and the operating range was not displayed. In addition, the recalibration date was not documented on either the weighing balance label or the calibration certificate. The calibration label indicated a calibration date of 03 February, but the recalibration date was noted as To be advised. d) The pH meter operating range was also not indicated. |
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| 18 | Other | 18 SMF — SMF The SMF did not include GPS coordinates of the facility. |
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