samples are collected for analysis and quality evaluation.

3. Responsibilities

• Production Officer: Responsible for collecting samples as per defined plan.
• IPQA Officer: Verifies correct sampling, labels, and documentation.
• QC Analyst: Receives samples and performs required tests.

4. Accountability

The Head – Quality Assurance is accountable for overall compliance and ensuring sampling procedures are followed during manufacturing operations.

5. Procedure

5.1 Sampling Plan

1. Sampling must be performed based on approved sampling plan and batch manufacturing record (BMR).
2. Sampling stages may include:
   • Raw material sampling
   • In-process bulk sampling
   • Post-filtration sample
   • Finished product sample
   • Environmental and rinse water sample

5.2 Sample Collection Procedure

1. Ensure clean and sterile containers for sample collection.
2. Use sterile tools (pipettes, sampling needles) and handle with gloves.
3. Label each sample immediately with:
   • Batch No.
   • Sample Type
   • Date/Time
   • Sampler Name
4. Enter sample details in the Sampling Logbook (Annexure-1).
5. Transfer the samples promptly to the Quality Control laboratory.

5.3 Sample Labeling

1. Use pre-printed or computer-generated labels where applicable.
2. Ensure clear legibility and tamper-evident labeling.

5.4 Sampling Precautions

1. Do not sample from damaged or leaking containers/vials.
2. Ensure aseptic techniques are used during all sampling.
3. Avoid cross-contamination between samples.

5.5 Sample Quantities

1. Follow BMR or SOP-defined quantity for each sample type.
2. Minimum quantity must be sufficient for complete testing and retention sample (if applicable).

5.6 Documentation

1. All samples must be recorded in the Sampling Logbook and annexure forms.
2. Details to be entered include:
   • Date and Time
   • Sampler Name
   • Batch and Sample Details

6. Abbreviations

• SOP: Standard Operating Procedure
• IPQA: In-Process Quality Assurance
• QC: Quality Control
• BMR: Batch Manufacturing Record

7. Documents

1. Sampling Logbook – Annexure-1
2. Sample Label Template – Annexure-2
3. Sample Transfer Form – Annexure-3

8. References

• WHO TRS 986 Annex 2: GMP for Sterile Products
• ICH Q7: GMP for Active Pharmaceutical Ingredients
• 21 CFR Part 211 – Current Good Manufacturing Practice

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Manufacturing Executive	QA Executive	Head QA
Department	Production	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: Sampling Logbook

Date	Batch No.	Sample Type	Quantity	Sampler Name	Remarks
18/06/2025	INJ-BT-3021	In-process	20 mL	Rajesh Kumar	Complies

Annexure-2: Sample Label Template

Label Field	Example Entry
Sample Type	Bulk Solution
Batch No.	INJ-BT-3021
Date	18/06/2025
Sampler	Sunita Reddy

Annexure-3: Sample Transfer Form

Date	Sample Type	Transferred By	Received By	QC Comments
18/06/2025	Post-filtration	Rajesh Kumar	Vinay Pawar	Accepted

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial Issue	New SOP	QA Head
18/06/2025	2.0	Updated documentation and annexures	Periodic Review	QA Head