the required tests, documenting the results accurately, and ensuring proper handover of the results for archiving.

4. Accountability

The Manufacturing Manager is accountable for ensuring that analytical test results are archived in accordance with this SOP. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Collecting Analytical Test Results

1. Once analytical tests are performed, ensure that all results are accurately documented in the designated testing logs or worksheets. These documents should include:
   • Test type (e.g., microbial, physical, chemical tests)
   • Test results with units of measurement
   • Test date and time
   • Operator’s name or ID
   • Any observations or deviations from the standard
2. Ensure that all test results are signed and dated by the laboratory personnel who performed the test.
3. In case of any deviations, document the deviation in the Deviation Log (Annexure-1) and ensure that corrective actions are recorded.

5.2. Reviewing Analytical Test Results

1. The QA team is responsible for reviewing analytical test results to ensure that they meet regulatory requirements and internal specifications. The review should include:
   • Verification of the completeness of the test results
   • Ensuring that all necessary tests have been performed
   • Checking that the results meet acceptance criteria
2. If the results meet the specifications, the QA team should approve the test results and document the approval in the testing log.
3. If any discrepancies are identified, the QA team should initiate an investigation and document corrective actions as necessary.

5.3. Archiving Analytical Test Results

1. Once the test results are reviewed and approved, they should be archived in either a physical or electronic format. The following steps should be followed for archiving:
   • Store paper-based records in a secure, designated storage area that is only accessible to authorized personnel.
   • For electronic records, store the data in a validated and secure electronic system. Ensure that access control is implemented to restrict unauthorized access.
   • Ensure that the records are indexed and searchable by parameters such as product batch number, test type, and date of testing to facilitate easy retrieval during audits, inspections, or investigations.
2. Ensure that all archived analytical test results are retained for the required duration as specified by company policy or regulatory guidelines. Generally, the retention period for these records is no less than 3 years after the product’s shelf life or regulatory expiration date.

5.4. Retrieving Archived Test Results

1. In the event that archived test results are needed for an audit, inspection, or investigation, the records should be retrieved in a timely manner. Ensure that the retrieval process is documented in the Archive Retrieval Log (Annexure-2).
2. Only authorized personnel should have the ability to retrieve archived records. Ensure that the retrieval process includes a sign-in and sign-out procedure to maintain an audit trail.

5.5. Documenting and Handling Deviation Results

1. If any test results fall outside the specified limits, they should be documented as deviations in the Deviation Log (Annexure-1). The following information should be included:
   • A description of the deviation
   • The root cause of the deviation
   • Corrective and preventive actions taken to address the deviation
2. Corrective actions should be tracked and verified to ensure that the issue has been addressed before the product can proceed to the next stage of production.

5.6. Archiving Electronic Test Data

1. Ensure that electronic test data is backed up regularly to prevent data loss. The IT department should ensure that proper data retention policies are followed for electronic records.
2. For records stored electronically, ensure that the file formats used for storing test results are compatible with long-term archiving systems and comply with regulatory standards for data integrity and security.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• SOP: Standard Operating Procedure
• CAPA: Corrective and Preventive Action
• BMR: Batch Manufacturing Record
• PCR: Product Control Record
• QC: Quality Control

7. Documents

1. Analytical Test Result Log (Annexure-1)
2. Archive Retrieval Log (Annexure-2)
3. Deviation Log (Annexure-3)

8. References

This SOP is based on the following regulatory guidelines and industry standards:

• Good Manufacturing Practice (GMP) Guidelines
• FDA Code of Federal Regulations (CFR) Title 21, Part 211
• ISO 9001 – Quality Management Systems

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Analytical Test Result Log

Batch Number	Test Type	Test Results	Test Date	Operator	Remarks
BN-12345	Weight Check	50g	06/02/2025	Rajesh Patel	Pass
BN-12345	Fill Volume	200ml	06/02/2025	Rajesh Patel	Pass

Annexure-2: Archive Retrieval Log

Record ID	Record Description	Requested By	Request Date	Retrieved By	Retrieval Date
AT-12345	Analytical Test Result for BN-12345	Anjali Sharma	06/02/2025	Rajesh Patel	06/02/2025

Annexure-3: Deviation Log

Deviation ID	Description	Corrective Action	Responsible Person	Status
DEV-12345	Deviation in particle size distribution	Adjusted formulation process	Rajesh Patel	Completed

12. Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By	Page No.	Ref. Point No.	Details of Revision
01/01/2024	V 1.0	Initial Release	First Issue	Anjali Sharma	Page 1	[Ref Point]	First Release
01/01/2025	V 2.0	Updated archiving procedures	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures