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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 | 29/01/2026 | Pharma | 1. Immidiate
2. January 2026
3. January 2026 | Muneeb Shahid | 06/01/2026 | Syed Mohammad Zohaib Ali Rizvi | 08/05/2026 |
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| 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.
| June 2026 | N/A | In Progress | 05/03/2026 | Pharma | 1. May 2026 2. May 2026 3. May 2026 4. June 2026 | Syed Mohammad Zohaib Ali Rizvi | 17/03/2026 | Syed Mohammad Zohaib Ali Rizvi | 15/05/2026 |
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| CAPA-0003-26 | 06/03/2026 | Self Inspection IT | | | | | | | Pharma | | Syed Mohammad Zohaib Ali Rizvi | 17/03/2026 | | |
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| CAPA-0004-26 | 09/03/2026 | As per DR-0002-26. The old artwork unit carton (Material Code: 1200000776) were issued as per the pick list for Guatemala (export) PS packs, instead of revised artwork unit cartons. As a result, over printing was performed on the old artwork unit cartons and afterwards new picklist was issued for issuance of New Artwork unit carton. | Printed Unit Cartons (Material Code:1200004645) Lot no: 68511 were placed on hold and has deviation has been raised. | 1. Old artwork printed unit carton will be discarded.
2. New BPR will be issued.
3. All remaining stock of old artwork unit cartons shall be identified and discarded.
4. QA approval check shall be incorporated in SAP for revision of the any pick list.
| May | N/A | In Progress | 09/03/2026 | Pharma | 1. Immediate 2. March 26 3. April 4. May | Syed Mohammad Zohaib Ali Rizvi | 17/03/2026 | Syed Mohammad Zohaib Ali Rizvi | 15/05/2026 |
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| 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 |
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| CAPA-0006-26 | 27/03/2026 | Self Inspection QC Ceph
Description of Concern:
2. Major:
2.1 Labelling:
a) pH Meter (Mettler Toledo) in wet chemistry section was under qualification but no label for “under qualification” available on equipment.
b) Shaker equipment (ACE) in wet chemistry lab does not bear any equipment ID.
c) 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.
d) No label on titrant bottle of Perchloric and sodium hydroxide of potentiometer was available.
2.2 Calibration and Standardization:
a) 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).
b) No standardization was performed from august 2025 for volumetric solutions of Perchloric acid and sodium hydroxide. (frequency for standardization for Perchloric acid is 3 months and sodium hydroxide is 1 month as per SOP (QCG/2/022)).
3. Others/minor:
3.1 QAG/5/004 master list of SOP checked, in which QAG/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 Trending of viable and non-viable was performed on uncontrolled formats
3.7 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.
3.8 During review of SOP of GPT, Logbook QCM/5/045 (growth promotion test report) was checked in which 3 microorganisms were performed for SDA media lot # 6224114 however, in SOP only one media is mentioned and no clause regarding alternate microorganism usage in case of unavailability of mentioned microorganism available in SOP.
3.9 No desiccant was present on sodium hydroxide titrant bottle of potentiometer.
| Immediate Action (Correction) Taken:
2.1 Labeling:
a) The pH Meter (Mettler Toledo) in the wet chemistry section was immediately tagged with an Under Qualification status label.
b) Assigned a unique equipment ID (QC-SHK-002) to the shaker (A as per SOP (QCG/2/107) for Assigning Identification Number of Instruments in QC Laboratory.
c) An updated calibration tag was immediately affixed to the equipment to reflect current calibration status.
d) All titrant bottles were labeled as per requirement of our SOP.
2.2 Calibration and Standardization:
a) Calibration certificates were reviewed and it was identified that the instrument was calibrated for 12 months, however due to a typographical error, 6 months was mentioned. The master calibration sheet will be revised to update the correct calibration details.
b) 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.
3.0 Others/Minors:
3.1 All overdue SOPs were update within two months and the SOPs will be either revised (where required) or reapproved with documented justification for no change.
3.2 The master sheet for testing methods will be provided to QA, and training on record traceability will be conducted for QC staff.
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 happened at the missing period of time.
3.7 Supplier CAPA response status was followed up actions required for closure have been completed. The documentation has been re-verified and approved on the current date.
3.9 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
| Proposed Corrective / Preventive Action (CAPA) to be Taken:
2.1 Labeling:
a) Training will be provided to the concerned personnel on equipment status labeling requirements to ensure proper identification and control of equipment under qualification.
b) 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.
c) 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.
d) Refresher training of concerned staff on proper labeling practices and documentation requirements.
2.2 Calibration and Standardization:
a) Introduce a second-person verification step for all calibration entries and due date assignments and update.
b) The SOP for labeling of QC reagents will be provided to quality control staff.
3.0 Others/Minors:
3.1 The QC Documentation Section In-Charge will be responsible for ensuring that the updated master copies of QC SOPs are available in the QC department.
3.2 Training on document review will be given all concern persons.
3.3 Training on respective SOP 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 SOP for environmental monitoring (QCM/2/033) will be revised and format for trend analysis will be controlled by document controlling section.
3.7 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.
3.8 SOP for GPT (QCM/2/002) will be revised and other microorganisms will be incorporated for growth promotion testing.
3.9 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
| June 2026 | N/A | In Progress | 27/03/2026 | Pharma | 2.1 June 2026 2.2. June 2026 3.0 June 2026 3.1 June 2026 3.2 June 3.3 June 2026 2026 3.3 June 2026 3.4 June 2026 3.5 June 2026 3.6 June 2026 3.6 June 2026 3.7 June 2026 3.8 June 2026 3.9 June 2026 | Syed Mohammad Zohaib Ali Rizvi | 08/04/2026 | Syed Mohammad Zohaib Ali Rizvi | 15/05/2026 |
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| 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. Concerned QAI was informed and batch was transferred to WIP.
2. Engineering team was Immediately notified to rectify the issue.
| 1. A new CAM will be installed on the compression machine to restore equipment functionality.
2. CAM functionality will be verified by the Validation Team prior to release for routine operation.
3. Compressed tablets will be passed through a metal detector to ensure absence of any metallic particles potentially generated from CAM breakage.
4. Compression activities will be resumed after completion of line clearance and QA approval.
5. SOP No. ENO/2/073 (Preventive Maintenance of ZP37-BII) will be revised to include CAM inspection, wear and tear assessment, and bolt tightening verification in quarterly maintenance.
6. SOP No. PMT/2/054 (Cleaning, Lubrication & Operation of ZP37-B2 Rotary Tablet Compression Machine) will be revised to incorporate pre-operational CAM verification prior to machine start-up and cleaning and bolt tightening will be part of change over.
7. Training will be provided to relevant Engineering personnel on revised SOP requirements and criticality of CAM assembly checks.
8. CAMs of all compression machines will be inspected for wear and tear and bolt tightening integrity to prevent recurrence of similar incidents.
| June 2026 | N/A | In Progress | 08/04/2026 | Pharma | 1. April 2026 2. April 2026 3. April 2026 4. April 2026 5.June 2026 6. June 2026 7. June 2026 8. June 2026 | Syed Mohammad Zohaib Ali Rizvi | 23/04/2026 | Syed Mohammad Zohaib Ali Rizvi | 15/05/2026 |
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| CAPA-0008-26 | 28/04/2026 | Self Inspection Engineering
2.1. CAPA Verification:
a. The observation regarding overflow PW sensors has already been addressed as part of the CAPA from the previous audit. As a corrective and preventive measure, these sensors have not been incorporated into the monthly preventive maintenance plan to ensure regular monitoring and to avoid recurrence of the issue.
b. The observation related to the review of maintenance reports has been addressed under the CAPA from the previous audit. As a corrective and preventive action, a separate T-code will be developed in SAP to facilitate efficient review.
2.2. Documents and Data control:
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. Maintenance Program:
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. Utilities:
a. The review of Format ENG/5/081 (Monitoring of AHU in Technical Area) revealed multiple deficiencies, the relevant SOP reference was not mentioned on format uncontrolled format was used to record, further the filter checks were recorded only on a visual basis without documenting differential pressure (Pascal) readings from gauges and no specific record of HEPA filter incineration was available with only the number of filters recorded.
3.1. Inspection of Hand and Power tools:
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. RO Plant:
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 readings are checked daily and satisfactory condition of filters are documented on ENG/5/081. 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 recording will be recorded.
| 2.2(b) SOPs 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.
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-26 | N/A | In Progress | 28/04/2026 | Pharma | 2.2(b) Aug-26 2.2(c) Aug-26 2.3(a) Aug-26 3.1(a) June-26 3.2 (b) July-26 | Syed Mohammad Zohaib Ali Rizvi | 28/04/2026 | Syed Mohammad Zohaib Ali Rizvi | 15/05/2026 |
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| 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 .
| June 2026 | N/A | In Progress | 28/04/2026 | Pharma | 1. June 2026 2. June 2026 3. June 2026 4. June 2026b | Syed Mohammad Zohaib Ali Rizvi | 28/04/2026 | Syed Mohammad Zohaib Ali Rizvi | 15/05/2026 |