Good Manufacturing Practices (cGMP), WHO, and ICH guidelines before batch disposition.

2. Scope

This SOP applies to all personnel involved in the review of QC analytical results for raw materials, in-process samples, and finished injectable products manufactured at the facility.

3. Responsibilities

• QC Analyst: Performs analysis and documents results in test reports and laboratory notebooks.
• QC Reviewer: Conducts second-level review of data, calculations, and compliance with SOPs.
• QA Officer: Verifies test results against product specifications and reviews for GMP compliance.
• Head QC: Final reviewer and approver of QC documents before batch release.

4. Accountability

The Head of Quality Control is accountable for ensuring the integrity, accuracy, and completeness of all QC test results prior to product release.

5. Procedure

5.1 Collection and Compilation of Test Results

1. All QC testing must be conducted using validated methods as per the approved specifications.
2. Analysts shall compile the raw data, chromatograms, calculation sheets, instrument printouts, and test reports in a designated folder labeled with batch number (Annexure-1).

5.2 First-Level Review by QC Reviewer

1. The assigned reviewer shall:
   • Cross-check analytical calculations and results
   • Verify chromatogram integration and peak identification
   • Ensure compliance with the standard method of analysis
   • Confirm instrument calibration and environmental log entries
2. In case of discrepancies or missing data, the folder shall be returned to the analyst for correction or justification.

5.3 Comparison with Approved Specifications

1. The reviewer shall compare each result with respective product specifications including:
   • Assay (potency)
   • pH, Osmolality
   • Particulate matter
   • Endotoxin and Sterility
   • Impurity profile and residual solvent limits
2. Record the final results in the Finished Product Specification Summary Sheet (Annexure-2).

5.4 Review of OOS, OOT, and Deviations

1. If any Out-of-Specification (OOS) or Out-of-Trend (OOT) result is observed:
   • Verify if it has been previously investigated
   • Ensure proper documentation and CAPA were implemented

5.5 QA Review and Approval

1. QC results folder is sent to QA for a second-level review.
2. QA verifies:
   • QC Reviewer’s sign-off
   • Completeness of documents
   • Test compliance with specifications
3. Once approved, QA stamps the “Approved for Release” status on the QC Report (Annexure-3).

5.6 Archival

1. All test results shall be scanned and saved electronically on the secure QA drive with backup maintained.
2. Hard copies shall be filed batch-wise and retained as per company record retention policy.

6. Abbreviations

• SOP: Standard Operating Procedure
• QC: Quality Control
• QA: Quality Assurance
• OOS: Out of Specification
• OOT: Out of Trend
• GMP: Good Manufacturing Practice

7. Documents

1. QC Data Folder Checklist – Annexure-1
2. Specification Summary Sheet – Annexure-2
3. QC Report Approval Form – Annexure-3

8. References

• ICH Q6A: Specifications – Test Procedures and Acceptance Criteria
• WHO GMP Guidelines for Pharmaceuticals
• 21 CFR Part 211 Subpart I – Laboratory Controls

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	QC Executive	QA Executive	Head QA
Department	Quality Control	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: QC Data Folder Checklist

Item	Available	Remarks
Chromatograms	Yes	All attached
Calculations	Yes	Verified
Raw Data	Yes	Signed
Specifications	Yes	Current version used

Annexure-2: Specification Summary Sheet

Test	Result	Specification	Complies
Assay	98.7%	90-110%	Yes
pH	6.5	5.5–7.0	Yes
Particulate Matter	Complies	NMT 6000 particles ≥ 10µm	Yes

Annexure-3: QC Report Approval Form

Batch No.	IVX2204
Product	Injexol 100mg
QC Reviewer	Sunita Reddy
QA Reviewer	Rajesh Kumar
Release Status	Approved for Release

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial Release	New SOP	QA Head
24/06/2025	2.0	Updated review steps and annexures	Annual Review	QA Head