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| CAPA-0001-26 | 05/01/2026 | As per DR-0001-26-P, During labeling on the self-adhesive auto-labeling machine, label wrinkling was observed due to incompatibility between label and bottle dimensions. | Process was stopped and deviation has been raised. | 1. Training will be provided to QC packaging staff.
2. New labels with accurate dimensions will be procured.
3. Labelling will be carried out after procurement of new Lables.
| January 2026 | N/A | Closed | 15/01/2026 | Pharma | 1. Immidiate
2. January 2026
3. January 2026 | Muneeb Shahid | 06/01/2026 | Syed Mohammad Zohaib Ali Rizvi | 16/06/2026 |
|
| CAPA-0002-26 | 05/03/2026 | Self Inspection SCM
3.1 During review of SOP MMI/2/004, It was observed that the practice through which PR is generated and processed does not align with the stated procedure. (e.g. for creation SAP is used however, SOP does not have any clause that mentions that SAP system will be utilized for creation of PR)
3.2 JD of newly inductee (i.e. Ayaz Khan) at the time of audit was not available.
3.3 In SOP MMI/2/004, Annexure 1 is mentioned at clause 8.1.11, however, a separate controlled format was attached containing authorization detailing. SOP needs to be aligned accordingly.
3.4 SOP MMI/2/001 is not aligned with the practices. Furthermore, a document named “document control sheet” contains multiple signatures without clarity of authority and identification. SOP needs to be aligned accordingly.
3.5 SOP PLE/2/003 was reviewed, however, it was found that the SOP is not aligned to the practices. For instance, refer to clause 8.1.5, digitalized web portal is used but it is not mentioned in the SOP. SOP needs to be revised
| 3.2 JD was not presented at the time of audit however signed JD was available (evidence is attached). | 3.1 SOP MMI/2/004 will be revised to mention about the procedure for SAP system.
3.3 In SOP MMI/2/004, clause 8.1.11 mentioning annexure 1 (typographical error) will be replaced with approval matrix for purchases (MMI/5/009) .
3.4 SOP MMI/2/001 will be revised as per current practices. Document control sheet will be revised and designation will be mentioned in signatories.
3.5 SOP PLE/2/003 will be revised as per current practices.
| Aug 2026 | N/A | In Progress | 05/03/2026 | Pharma | 1. Aug-2026 2. Aug-2026 3. Aug-2026 4. Aug-2026. | Syed Mohammad Zohaib Ali Rizvi | 17/03/2026 | | 14/07/2026 |
|
| CAPA-0003-26 | 06/03/2026 | Self Inspection IT
2.1 There was no procedure for qualification of vendors for IT systems developed outsourced or services taken from vendors.
3.1 JD’s does not reflect the persons involved in controlling of GMP softwares.
3.2 Risk Assessment of Critical GMP systems not performed (like SAP, LIMS and others).
3.3 Persons involved in development of SOPs are not trained on the procedures.
3.4 Persons involved in controlling of GMP softwares are not trained on relevant procedures.
3.5 Training records of IT persons not available at the time of audit.
3.6 TNA program available, however training program does not contain any topic related to computer system validation.
3.7 Control list of persons who holds admin rights was unavailable at the time of audit. | 3.7 List of authorize person was not available at the designated place which was later placed in folder. Evidence of list attached. | 2.1 Procedure will be developed for qualification of vendors for software systems.
3.1 JD of manager MIS and Executive MIS will be revised to incorporate the clause of controlling admin rights og GMP systems.
3.2 Risk assessment for Critical GMP systems will be added in annual risk plan at the time of preparation of annual risk planner for next year.
3.3 Training of IT personnels on procedure QAG/2/056 (Procedure for preparation, review and retrieval of SOPs at PharmEvo Site) will be provided.
3.4 Training of IT personnels on procedure QAV/2/009 (SOP for computerized system validation) and SOP CDG/2/001 (SOP for management of data integrity) will be provided.
3.5 & 3.6 TNA will be prepared for the MIS team and must include training on SOP QAV/2/009.
| Aug-26 | N/A | In Progress | 03/06/2026 | Pharma | 1.Aug-26 2. Aug-26 3. Aug-26 4. Aug-26 5. Aug-26 6. Aug-26 | Syed Mohammad Zohaib Ali Rizvi | 17/03/2026 | Syed Mohammad Zohaib Ali Rizvi | 17/06/2026 |
|
| CAPA-0004-26 | 09/03/2026 | As per DR-0002-26-P. The old artwork unit cartons (Material Code: 1200000776) Lot no: 68511 were issued for packaging of Guatemala (Export) PS packs instead of the revised artwork unit cartons. Consequently, overprinting was performed on the old artwork unit cartons. | Printed Unit cartons (Material Code: 1200000776) Lot no: 68511 were placed on hold and deviation was raised. | 1. Old artwork printed unit carton will be discarded.
2. Revised artwork unitcartons will be issued.
3. New BPR will be issued.
4. Regulatory Affairs (RA) shall ensure timely initiation of Change Control requests upon receipt of approval for any variation related to artwork revision.
| March | N/A | Closed | 30/03/2026 | Pharma | 1. March 26 2. March 3. March 26 4. Immediate | Syed Mohammad Zohaib Ali Rizvi | 17/03/2026 | Syed Mohammad Zohaib Ali Rizvi | 16/06/2026 |
|
| CAPA-0005-26 | 09/03/2026 | As per DR-0003-26-P, during compression of Avsar Plus 160/10/25, Batch No. 6B302, on the ZPW-23 compression machine, tablet hardness values were observed to be in the range of 5–20 kg, exceeding the upper specification limit of 15 kg as defined in the approved BMR. | Compression process was stopped and deviation has been raised. | The tablet hardness limits specified in the BMR shall be revised from 5–15 kg to 5–20 kg based on evaluation of historical batch data and the observed results. | April-2026 | N/A | Closed | 08/04/2026 | Pharma | April-2026 | Syed Mohammad Zohaib Ali Rizvi | 17/03/2026 | Syed Mohammad Zohaib Ali Rizvi | 15/05/2026 |
|
| CAPA-0006-26 | 27/03/2026 | Self Inspection QC Ceph
Description of Concern:
2.1. No record is maintained for receiving of incoming finished good samples for testing in micro lab.
2.2. API material from alternate vendor development for trial is received in QC Ceph but no traceability of receiving present
3.1. Working limit is not pasted on biosafety cabinet in micro lab. Similarly, no precaution is displayed for safe sash height during operation of biosafety cabinet.
3.2. No traceability is found for receiving and consumption of LAL reagent, lot # AJ30703056.
3.3. Solution/ bottles of pH buffers (4,7 and 9) found to be turbid while label do not cover the transfer date of in-use buffer solutions from stock bottles.
3.4. No working limit is defined for top balance placed in micro lab.
3.5. QCG/2/002 for validation and verification of analytical test method found overdue.
3.6. AMVR-178/01 & AMVR-001/25 report checked but audit trail of HPLC system not available.
3.7. List of materials and products of compendial and non-compendial method not available.
3.8. Copy of approved organogram was not available in the Lab.
3.9. Hiring criteria (QCG/5/236) was reviewed in which PT Testing was mentioned in the QC Executive (Analyst) competency requirements. Mr Ahmed (Analyst) was asked about PT, however, he could not define.
3.10. TNA Form (QCG/5/267) dated 16-03-2023 was reviewed and found inappropriately filled e.g. leaving blank columns and incomplete data. | Immediate Action (Correction) Taken:
3.1. Working limit of pressure guage label is pasted and also sash height arrow is mentioned in label.
3.2 LAL reagent receiving was done in SAP as per Procedure SOP # QCG/2/010 However at the time of audit hard copy of GRN was not retrieved timely. Hard copy of GRN submitted for evidence.
3.3. Opaque bottles is in use due to which this observation occurred. It is replaced with transparent glass bottle. Evidence of glass bottle provided.
3.4. Working limit of top load balance label is pasted in micro lab.
3.5. The SOP QCG/2/002 for analytical method validation and verification was effective but not available at the bench level during the audit.Immediately arrange the control copy of effective SOP from QA and make it physically/digitally available at the QC work station.
| Proposed Corrective / Preventive Action (CAPA) to be Taken:
2.1 In QC, an incoming log book is available, but it is combined for both Microbiology and QC. A separate incoming log book should be issued for Microbiology for receiving of incoming finished good samples for testing of micro lab log book Ref. SOP No# QCG/2/023.
2.2 The logbook for receiving API materials from alternate vendors is mandated by SOP QCG/2/023
(Sample Receiving, Testing, and Release of RM, Semi-Finished, and FG Products) because these materials are received infrequently, the QC Ceph lab recorded entries in an Excel sheet instead of the physical logbook due to inadequate training.To rectify this, QC will maintain a formal logbook and will ensure all future materials are logged therein. Additionally, a formal training session will be conducted for QC staff regarding the receipt of materials from alternate vendors, with a strict emphasis on ensuring full traceability.
3.2 SOP will be revised QCM/2/013 to prepare format for consumption of LAL reagent water to maintain record of consumption.
3.5. A refresher training session will be provided to QC staff on the importance of "Current Version Only" compliance and the risks of using obsolete documents.
3.6 The Audit Trail checklist is mandated by SOP QCG/2/068, 'Review of Audit Trails.' Although
the review procedure is clearly defined in the SOP, QC personnel failed to complete the checklist, resulting in a procedural deviation due to human error.To rectify this, the QC Supervisor will perform a retrospective review of the audit trails for reports AMVR-178/01 and AMVR-001/25. These audit trails will be attached to the respective reports with the signing on current date.Furthermore, the QC Supervisor or a designee will conduct a refresher training session for all QC analysts and supervisors on Audit Trial SOP QCG/2/068.
3.7 QC will take format number from QA and prepare and control the list for material and finish product as per compendial and non-compendial methods.
3.8 Revised the organogram to update the revision history by adding “QC Ceph lab” in distribution list.
3.9 Conduct a inhouse refresher training session for Mr. Ahmed on clauses of ISO/IEC 17025 specifically covering the definition, purpose, and procedure of Proficiency Testing (PT).
3.10 Any blank spaces will be struck through, and comprehensive training on Good Documentation Practices (GDocP) will be provided to all the QC analyst. | June 2026 | N/A | In Progress | 07/05/2026 | Pharma | 1. May-26 2. 2. May-26 3. May-26 4. May-26 5. May-26 6. May-26 7. June-26 8. May-26 9. May-26 | Syed Mohammad Zohaib Ali Rizvi | 08/04/2026 | Syed Mohammad Zohaib Ali Rizvi | 17/06/2026 |
|
| CAPA-0007-26 | 08/04/2026 | As per DR-004-26-P, During compression of Sacvin 100 mg Tablets, Batch No. 6C209, on ZP37B-II Compression Machine, CAM breakage occurred due to loosening of the CAM bolt during operation. | 1. The concerned QAI was informed immediately, and the tablets compressed during the CAM breakage were segregated and set aside for rejection. The batch was placed on hold.
2. The Engineering Department was immediately notified to rectify the issue.
| 1. The broken CAM will be replaced to restore the machine to operational condition.
2. All CAM bolts will be inspected and tightened .
3. Compression will be resumed to complete the remaining portion of the batch after verification of machine readiness.
4. The quarterly preventive maintenance checklist will be revised to include inspection of CAMs for wear and tear, as well as verification and tightening of CAM bolts.
| Aug 2026 | N/A | In Progress | 08/04/2026 | Pharma | 1. May 26 2. May 26 3. May 26 4. Aug 26 | Syed Mohammad Zohaib Ali Rizvi | 23/04/2026 | Syed Mohammad Zohaib Ali Rizvi | 16/06/2026 |
|
| CAPA-0008-26 | 10/04/2026 | Self Inspection QC General Pharma
2.1.1 pH Meter (Mettler Toledo) in wet chemistry section was under qualification but no label for “under qualification” available on equipment.
2.1.2 Shaker equipment (ACE) in wet chemistry lab does not bear any equipment ID.
2.1.3 Karl Fischer Mettler Toledo V20, in wet chemistry lab does not bear the updated calibration status. Calibration was performed as per defined frequency but updated calibration tag not available on equipment.
2.1.4 No label on titrant bottle of Perchloric and sodium hydroxide of potentiometer was available.
2.2.1 QC/3/001 Instrument calibration list of QC department was checked in which
contradiction in duration and dates of HPLC-18, HPLC-19 & HPLC-20 observed, calibration duration mentioned was six months however calibration performed on 18-03-2025 and next due date was 17-03-2026 (1 year).
2.2.2 No standardization was performed from august 2025 for volumetric solutions of Perchloric acid and sodium hydroxide. (frequency for standardization for Perchloric acid is three months and sodium hydroxide is one month as per SOP reference Number QCG/2/022).
3.1 QAG/5/004 master list of SOP checked, in which QCG/2/002, QCG/2/004, QCG/2/005, QCG/2/022 & QCG/2/044 found overdue.
3.2 Compendial and innovator method list was available without any control number.
3.3 During stock chemical review, a reagent (2000001581) was selected but GRN of that material was not available.
3.4 Water testing result trending was checked for the month of January however no control number on trend was available.
3.5 QCI/5/066 (weekly cleaning of eyewash & safety shower log) was checked and it was filled till 12-01-2026.
3.6 QCG/5/028 logbook for complaint handling for packaging material was checked, in which “action taken regarding complaint on site” & “CAPA response received from supplier” columns were empty.
3.7 No desiccant was present on sodium hydroxide titrant bottle of potentiometer.
| 2.1.1 The pH Meter (Mettler Toledo) in the wet chemistry section was immediately tagged with an Under Qualification status label.
2.1.2 Assigned a unique equipment ID (QC-SHK-002) to the shaker as per SOP for Assigning Identification Number of Instruments in QC Laboratory (QCG/2/l07).
2.1.3 Calibration of Karl fisher was performed as per routine procedure but analyst was forgetting to update the calibration tag. An updated calibration tag is immediately affixed to the equipment to reflect current calibration status.
2.1.4 All titrant bottles were labeled as per requirement of SOP “Good Laboratory Practice (QCG/2/001)”.
2.2.1 QCG/3/001 Calibration list has been updated (Rev. 07).
2.2.2 Volumetric solutions will be verified at the time of use. Sodium hydroxide solution will be standardized at the time of use if found expired, a fresh solution will be prepared and standardized prior to analysis.
Perchloric acid solution is not standardized internally, as it is supplied pre-standardized by the manufacturer expiry 17-04-2027.
3.1 QAG/5/004 master list will be reviewed for any other discrepancy.
3.2 The master sheet for testing methods will be provided to QA for review and confirmation of traceability requirements as per the approved relevant SOP.
3.3 During the review, the GRN for the selected reagent (2000001581) was not presented however, it is available in records. The relevant GRN has now been retrieved, verified, and documented to ensure proper traceability.
3.4 The correct format for water trending has been updated.
3.5 The eyewash and safety shower were inspected, and assigned a person for update in routine. There is no any incident reported during the missing period of time.
3.6 Supplier CAPA response status was followed up actions required for closure have been completed. The documentation has been updated, re-verified and approved on the current date.
3.7 A desiccant was immediately placed to the sodium hydroxide titrant bottle of the potentiometer to avoid moisture absorption. It was further confirmed that no testing was performed on the instrument during this period
| 2.1.1 Training will be provided to the concerned personnel on equipment status labeling requirements to ensure proper identification and control of equipment under qualification.
2.1.2 Training will be provided to the concerned personnel on the SOP for assigning identification numbers to laboratory instruments to ensure proper equipment identification and compliance with documentation requirements. All QC Lab instruments will be checked for any missing identification number and will update it.
2.1.3 Concerned personnel will be trained on proper calibration status labeling and timely updating of records to ensure accurate and up-to-date identification of equipment calibration status.
2.1.4 Refresher training of concerned staff on proper labeling practices and documentation requirements.
2.2.1 Calibration list will be reviewed through 2nd verification will be done prior to approved.
2.2.2 The Training on SOP for labeling of QC reagents will be provided to quality control staff.
3.1 Master list of standard operating procedure will be updated.
3.2 Refresher training on document control and record traceability will be conducted for QC personnel to ensure proper maintenance and identification of laboratory records in the future.
3.3 Training on respective SOP for SAP QM module (QCG/2/090) for receiving of chemicals will be provided to the concerned personnel to ensure availability and traceability of GRN and related records.
3.4 Refresher training will be provided to the concerned personnel and all raw material team on Purified water testing.
3.5 Dedicated a person for responsible updated entries and inspection and one-month record will send to Quality Assurance department.
3.6 Revise complaint handling SOP to include a mandatory documentation checklist ensuring all fields are completed prior to closure and implement a QA verification step before final approval of complaint records.
3.7 Training will be conducted for QC analysts on proper storage and handling of reagents, including the requirement for correct use of desiccants and proper labeling of titrant bottles. Routine periodic checks of reagent storage conditions will be implemented by the QC Supervisor.
| July-26 | N/A | In Progress | 09/06/2026 | Pharma | 1.July-26 2. July-26 3.July-26 4.July-26 5.July-26 6. July-26 7.July-26 8.July-26 9.July-26 10.July-26 11. July-2612. July-2613.July-26 | Syed Mohammad Zohaib Ali Rizvi | 28/04/2026 | Syed Mohammad Zohaib Ali Rizvi | 17/06/2026 |
|
| CAPA-0009-26 | 28/04/2026 | During the Product Quality Review (PQR) of X-Plended 20mg Tablets and Avsar Plus 160/10/12.5mg Tablet, it was identified that the obsolete tablet compression machine Fette P2000 and ZPW23D respectively remains listed in the BMR equipment checklist. However, other listed compression machines were used for manufacturing.
| The observation and corresponding recommendation were documented in the Product Quality Review (PQR). A Root Cause Analysis (RCA) was initiated to evaluate the underlying cause of the discrepancy and to define appropriate corrective and preventive actions (CAPA).
| "1. Identify BMRs having Fette P2000 and ZPW23D compression machines.
2. Revise BMRs to ensure inclusion of only currently qualified and active equipments in the equipment checklist.
3. Develop and implement SOP defining the procedure for decomissioning and removal of those equipment from batch documents.
4. Conduct training of all concerned personnel on the approved SOP .
"
| Aug-2026 | N/A | In Progress | 11/06/2026 | Pharma | 1. AUG-26
2. AUG-26
| Syed Mohammad Zohaib Ali Rizvi | 28/04/2026 | Syed Mohammad Zohaib Ali Rizvi | 16/07/2026 |
|
| CAPA-0010-26 | 28/04/2026 | "Self Inspection Engineering
Description of Concern:
Description of Concern:
Self inspection audit CAPA.
2.2. a. Master list of SOPs of Engineering (Document No QAG/5/004) was not available.
b. Few SOPs within the Engineering Department were found to be expired at the time of audit.
c. TNA records for Sr. Manager Engineering, AM Engineering, and Executive engineering were not available at the time of audit.
d. Copy No. 03 of SOP (ENO/2/113 Rev: 03 Operation of RO Plant) was found retained in the Engineering office file instead of being available at its designated point of use.
2.3. a. (SOP ENO/2/065) for maintenance management program does not define the process for inclusion of newly qualified equipment, facilities, and utilities into the maintenance management program, creating a risk that such assets may be omitted from the preventive maintenance plan. communication with QA Validation.
2.4. a. The review of Format ENG/5/081 (Monitoring of AHU in Technical Area), the relevant SOP reference was not mentioned on format, further the filter checks were recorded only on a visual basis without documenting differential pressure (Pascal) readings from gauges.
b. Record of HEPA filter incineration was available with only the number of incinerated filters rather than AHU wise HEPA filters.
3.1.a. Inspection of hand and power tools was conducted however, the Annexure ENO/5/002 (Monthly Inspection of Tools) record was not available for review.
3.2. a. Attachments ENO/5/084, ENO/5/083, and ENG/5/013 for SOP Operation of RO plant (ENO/2/113) Rev:02 were damaged and not readable.
b. Log sheet for operation of RO plant having format number (ENO/5/084) data logging was recorded from 9:00 am to 17:00 pm but the plant was in operation for 24 hours.
"
| "2.2(a) Masterlist of SOPs is available now. It was not found during audit , as whole Engineering Office was shifted back then and document files were not arranged.
2.2(d) Copy no 3 of SOP (ENO/2/113 Rev:3 Operation of RO plant) is placed at point of use.
2.4 (a)Differntial pressure readings are checked daily will be recorded on ENG/5/081.
(b) HEPA filter incineration record is documented on EIG/5/014. It will be ensured that the AHU number is mentioned on the record.
3.2(b) Log sheet for Operation of RO Plant ENO/5/006 has been approved, 24 hours data will be recorded.
| "2.2(b) SOPs will be submitted in QA for revision.
2.2(c) All training will be conducted and training records will be submitted.
2.3(a) A point will be incorporated in ENO/2/065 regarding inclusion of new equipment in maintenance management program.
2.4(a) Format No. ENG/5/081 and SOP No. ENH/2/001 will be revised to tag format within the SOP. Additionally, a daily monitoring clause will be incoperated in the SOP.
3.1(a) ENO/5/002 will be duly filled on monthly basis.
3.2(a) Duplicate of damaged documents will be issued through QA.
"
| Aug-2026 | N/A | In Progress | 08/06/2026 | Pharma | 2.2(b) Aug-26 2.2(c) Aug-26 2.3(a) Aug-26 2.4(a) May-26 3.1(a) June-26 3.2(a) May-26
| Syed Mohammad Zohaib Ali Rizvi | 03/06/2026 | Syed Mohammad Zohaib Ali Rizvi | 16/07/2026 |
|
| CAPA-0011-26 | 18/05/2026 | As per DR-0005-26-P, During granulation of Nise 100 mg Tablets, Batch No. 6F040, while off-loading the materials from cage onto a pallet, the polybags containing Colloidal Silicon Dioxide (Aerosil 200), Talcum Powder, and Magnesium Stearate accidentally slipped from the cage and fell onto the floor. Consequently, all three polybags got ruptured, resulting in spillage of the materials onto the floor. | 1. QAI was informed, and the spilled material was identified, collected and segregated for destruction.
2. Additional material was requested for batch continuation.
3. Deviation has been raised.
| 1. Training on material handling practices will be provided to production operators.
2. Polybags vendors will be qualified.
3. Testing method for polybags will be developed.
4. Train relevant staff on the new procedure.
| Aug 2026 | N/A | In Progress | 10/06/2026 | Pharma | 1. May-26 2. May-26 3. Aug-26 4. Aug-26 | Syed Mohammad Zohaib Ali Rizvi | 06/06/2026 | Syed Mohammad Zohaib Ali Rizvi | 16/06/2026 |
|
| CAPA-0012-26 | 23/05/2026 | As per DR-0006-26-P, during startup of BGK-350 for film coating of Erlina Plus XR 25/5/1000 mg Tablets, the BGK-350 Coating machine tripped and could not restart. | 1. Informed to QA and intimated to engineering team for the rectification of the issue.
2. Coating solution was set aside in enclosed S.S container until the rectification of issue.
3. Deviation has been raised.
| 1. The motor will be rewound, and the damaged bearings will be replaced with new bearings.
2. Faulty VFD will be replaced.
3. Coating solution will be discarded as it was not utilized as per its validated procedure.
4. Additional coating material will be issued for the batch coating.
| June-26 | N/A | Closed | 02/06/2026 | Pharma | 1. June-26
2. June-26
3. June-26
4. June-26 | Syed Mohammad Zohaib Ali Rizvi | 06/06/2026 | Syed Mohammad Zohaib Ali Rizvi | 03/07/2026 |
|
| CAPA-0013-26 | 25/05/2026 | As per DR-0007-26-P, during encapsulation of Zoltar 20mg Capsule Weight variation observed to be exceeding the defined limits. | 1. Informed to concerned QAI and process was hold.
2. Deviation was raised.
| 1. Complaint has been shared with vendor.
2. Further action will be proposed after receiving response from vendor.
| July-26 | N/A | In Progress | 11/06/2026 | Pharma | July-26 | Syed Mohammad Zohaib Ali Rizvi | 06/06/2026 | Syed Mohammad Zohaib Ali Rizvi | 18/06/2026 |
|
| CAPA-0014-26 | 04/06/2026 | In Self Inspection report Administration department, following observations were noted:
Major:
2.1 As per SOP QAG/2/024, In-case of change of batteries or induction of new clock in GMP area, it will be logged in logbook ADG/5/009 (Site clock Management logbook) however logbook was not available.
Minor:
3.1 During review of ADG/2/002, it was observed that secondary gowning used in areas was not defined in SOP.
3.2 Cleaning staff (mohan) was interviewed for preparation of cleaning solution and was unable to define the process.
| 3.2 Cleaner (Mohan) was immediately removed from solution preparation activity. | 2.1 Currently no clock is procured and batteries are not changed due to which logbook was not issued. Logbook will now be procured and issued from QA for clock management activities.
3.1 SOP ADG/2/002 will be revised and secondary gowning color coding will be mentioned in SOP.
3.2 Refresher training of cleaning staff will be given for preparation of cleaning solution. | July | N/A | In Progress | 15/06/2026 | Pharma | 1. July
2. July
3. June | Syed Mohammad Zohaib Ali Rizvi | 08/06/2026 | Syed Mohammad Zohaib Ali Rizvi | 15/06/2026 |
|
| CAPA-0015-26 | 04/06/2026 | During PQR, It was identified that Hold Time Study (HTS) was not included in the Validation Master Plan (VMP). As a result, HTS was not performed for the products listed in the attached document. This may result in a lack of documented evidence to support the established hold time data. | A review should be conducted to identify all products for which HTS was not performed. The list of products have been attached with this CAPA for further evaluation and action. | 1. Perform a risk assessment of the Listed products and execute Hold Time Studies where required. Update the relevant validation documents accordingly.
2. Revise the Validation Master Plan to include Hold Time Study requirements. | Dec-2026 | N/A | In Progress | 04/06/2026 | Pharma | Dec-26 | Syed Mohammad Zohaib Ali Rizvi | 07/07/2026 | | |
|
| CAPA-0016-26 | 04/06/2026 | During PQR, Quality agreements for the following attached Excipients, Primary & Secondary packaging materials from the approved supplier/manufacturers were not available during the review. The absence of these agreements may lead to unclear quality responsibilities and regulatory compliance gaps between the company and suppliers. | The materials were identified for which the quality agreements were not available. The concerned suppliers/materials were listed, and the matter was communicated to the Supply Chain department for the further action, follow-up and initiation of quality agreement acquisition. | 1. Supply Chain Department is recommended to arrange and execute quality agreements with the respective suppliers for all identified materials and products to ensure compliance with regulatory requirements and to clearly define quality responsibilities between both parties.
2. Furthermore, the SMS is also responsible to revise their relevant SOP to incorporate a clasue specifying that Quality Agreements must be established for Excipients, Primary Packaging Materials and Secondary Packaging Materials.
| June -2027 | N/A | In Progress | 04/06/2026 | Pharma | 1. June -2027
2. June -2027 | Syed Mohammad Zohaib Ali Rizvi | 07/07/2026 | | |
|
| CAPA-0017-26 | 04/06/2026 | During PQR, For certain analytical instruments and laboratory equipment's, only service agreements are currently available with the respective vendors, whereas quality agreements have not been established. | A review of existing vendor documentation was conducted, and service providers lacking quality agreements were identified. The gap was communicated to the concernced departments for further evaluation and action. | Quality Assurance/Quality Control shall assess the affected service providers and following satisfactory vendor evaluation, quality agreements shall be established and executed with the respective service providers to clearly define quality and regulatory responsibilities. A periodic review system shall be implemented to ensure that valid quality agreements are maintained for all critical service | Dec - 2026 | N/A | In Progress | 04/06/2026 | Pharma | 1. Dec - 2026
2. Dec - 2026 | Syed Mohammad Zohaib Ali Rizvi | 07/07/2026 | | |