standards.

5. Procedure

5.1 General Guidelines for Sampling Plan Development

1. Regulatory Requirements:
   • Sampling plans must comply with:
     • ICH Q7 – Good Manufacturing Practices for Active Pharmaceutical Ingredients
     • WHO GMP Guidelines
     • ISPE Guidelines on Material Sampling
2. Factors Affecting Sampling Plans:
   • Type of raw material (API, excipient, solvent, etc.)
   • Batch size and number of containers
   • Supplier history and material criticality
   • Storage conditions and material sensitivity (e.g., temperature, moisture)
   • Regulatory classification (e.g., hazardous, sterile, or controlled substances)

5.2 Sampling Plan Structure

1. Sampling Plan Components:
   • Material Description: Identify material type and critical attributes.
   • Batch Size: Total weight/volume of the batch and number of containers.
   • Sampling Method: Random, stratified, or systematic sampling.
   • Sample Size: Determine based on batch size and material criticality.
   • Tools and Equipment: Specify tools (e.g., sampling thieves, pipettes) and cleanliness requirements.
   • Documentation Requirements: Detail how to record sampling data.

5.3 Sampling Plan for Different Raw Material Types

5.3.1 Active Pharmaceutical Ingredients (APIs)

1. Sampling Method:
   • Stratified random sampling to ensure homogeneity.
   • Sample from top, middle, and bottom layers of containers.
2. Sample Size:
   • Minimum 10% of containers, not less than 2 containers, per regulatory guidelines.
3. Special Considerations:
   • For sterile APIs, use aseptic sampling techniques in a cleanroom environment.

5.3.2 Excipients

1. Sampling Method:
   • Random sampling for non-critical excipients.
   • Stratified sampling for functional excipients (e.g., disintegrants, binders).
2. Sample Size:
   • 5% of containers, with a minimum of 1 sample per batch.

5.3.3 Solvents and Liquids

1. Sampling Method:
   • Use sampling taps or draw samples from different levels (top, middle, bottom).
   • Ensure containers are grounded to prevent static discharge for flammable solvents.
2. Sample Size:
   • One sample per container for small batches; at least three containers for larger batches.

5.3.4 Hazardous and Temperature-Sensitive Materials

1. Sampling Method:
   • Follow specific safety protocols, including PPE and fume hood use.
   • For temperature-sensitive materials, maintain required storage conditions during sampling.
2. Sample Size:
   • Sample size should be minimized to reduce exposure risk but sufficient for accurate testing.

5.4 Documentation and Record-Keeping

1. Sampling Plan Approval:
   • Sampling plans must be documented and approved by QA before implementation.
2. Sampling Records:
   • Document all sampling activities in the Sampling Record Log (Annexure-1).
   • Include date, material name, batch number, sampling method, sample size, and personnel involved.

5.5 Handling Deviations in Sampling Plans

1. Deviation Reporting:
   • Report deviations such as incorrect sample size or missed containers to the QA Manager.
   • Document deviations in the Sampling Deviation Report (Annexure-2).
2. Corrective Actions:
   • Identify the root cause of deviations and implement corrective measures.
   • Document corrective actions in the Corrective Action Log (Annexure-3).

5.6 Training and Compliance

1. Personnel Training:
   • All personnel involved in sampling must be trained in the proper application of sampling plans.
   • Document training in the Training Log (Annexure-4).
2. Compliance Monitoring:
   • QA must conduct periodic audits to ensure compliance with sampling procedures.
   • Document audit findings in the Compliance Audit Log (Annexure-5).

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• QC: Quality Control
• API: Active Pharmaceutical Ingredient
• PPE: Personal Protective Equipment

7. Documents

1. Sampling Record Log (Annexure-1)
2. Sampling Deviation Report (Annexure-2)
3. Corrective Action Log (Annexure-3)
4. Training Log (Annexure-4)
5. Compliance Audit Log (Annexure-5)

8. References

• ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• WHO GMP Guidelines on Sampling
• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Sampling Record Log

Date	Material Name	Batch Number	Sampling Method	Sample Size	Sampled By
01/02/2025	API-X	API-X-2025-001	Stratified Random Sampling	5 Containers	Ravi Kumar

Annexure-2: Sampling Deviation Report

Date	Material Name	Batch Number	Deviation Description	Reported By
02/02/2025	API-X	API-X-2025-001	Incorrect Sample Size	Ajay Singh

Annexure-3: Corrective Action Log

Date	Deviation Description	Corrective Action	Implemented By	Verified By (QA)
03/02/2025	Incorrect Sample Size	Revised Sampling Plan and Retrained Staff	Ravi Kumar	Anjali Mehta

Annexure-4: Training Log

Date	Training Topic	Trainer	Attendee Name	Signature
04/02/2025	Sampling Plan Development	QA Manager	Sunita Sharma

Annexure-5: Compliance Audit Log

Date	Audit Type	Findings	Corrective Actions Taken	Audited By
05/02/2025	Sampling Plan Compliance Audit	Deviation in Sample Size Documentation	Updated SOP for Clearer Guidelines	Anjali Mehta

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP	QA Head
01/02/2025	2.0	Updated Sampling Procedures for Various Raw Materials	Regulatory Compliance	QA Head