3. Responsibilities

• Production Chemist: Coordinate with QC for control sample collection after batch processing.
• QC Analyst: Label, log, and store control samples as per defined procedures.
• QA Officer: Ensure sample integrity, verify labeling accuracy, and approve storage location and duration.

4. Accountability

The QA Head is accountable for ensuring control sample management complies with cGMP requirements and regulatory expectations.

5. Procedure

5.1 Sample Quantity

1. Collect at least twice the quantity required for a complete retesting of the material.
2. For APIs: minimum 200 g or as per regulatory/customer-specific requirement.
3. For intermediates (if retained): 50 g to 100 g depending on material nature.

5.2 Timing and Method of Collection

1. Collect control samples after batch is declared conforming and QA-approved.
2. Use clean, dry, inert, and appropriately sized containers (glass or HDPE with screw caps).
3. Avoid exposure to air, light, or moisture during transfer.

5.3 Labeling Requirements

1. Affix a control sample label (Annexure-1) with the following details:
   • Product Name
   • Batch Number
   • Manufacturing Date
   • Retest/Expiry Date
   • Storage Condition
   • Quantity Retained
   • Sample Code / Reference No.
   • Signature and Date
2. Use indelible ink or pre-printed labels with QA verification.

5.4 Storage Conditions

1. Store samples in a designated Control Sample Room or Chamber.
2. Conditions must be 25°C ± 2°C and 60% RH ± 5% unless specified otherwise.
3. Samples must be segregated batch-wise, product-wise, and year-wise in clean labeled bins or racks.

5.5 Duration of Retention

1. Retain samples for:
   • 1 year after batch expiry/retest date
   • Or as per contract/market regulations (e.g., 5 years for regulated markets)
2. After expiry of the retention period, discard samples with QA authorization following the Sample Disposal SOP.

5.6 Documentation

1. Record control sample collection in the Control Sample Logbook (Annexure-2).
2. QA shall verify entry and sign off.
3. Attach copy of label and sampling form to the Batch Manufacturing Record (BMR).

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• QC: Quality Control
• API: Active Pharmaceutical Ingredient
• BMR: Batch Manufacturing Record

7. Documents

1. Control Sample Label Template (Annexure-1)
2. Control Sample Logbook (Annexure-2)
3. Sample Disposal Authorization Form

8. References

• ICH Q7 – GMP for APIs
• 21 CFR Part 211 – US FDA cGMP
• WHO TRS 986 – GMP Guidelines

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Control Sample Label

Product Name
Batch Number
Mfg. Date
Retest/Exp. Date
Quantity Retained
Sample Code
Storage Condition
Collected By
Date

Annexure-2: Control Sample Logbook

Date	Batch No.	Sample Code	Quantity	Storage Location	QA Verified	Remarks
13/04/2025	API-20250413	CS-104	200 g	Rack B2		Stored

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial Issue	New SOP	QA Head
13/04/2025	2.0	Label template added; retention period clarified	Audit Improvement	QA Head