Standard Operating Procedure (SOP)

1. Purpose:
To establish a standard procedure for the sampling, testing, and quality assessment of finished products before their release for distribution or sale.

2. Scope:
This SOP applies to all finished products manufactured in the facility that require quality control approval before release.

3. Responsibility:

1. QC Analysts: Perform sampling and testing of finished products.
2. QC Supervisor/Manager: Review test results and approve/reject batches.
3. Production Team: Provide samples and necessary documentation.
4. QA Manager: Authorize final batch release.

4. Procedure:
4.1 Batch Completion Notification
Production department notifies QC upon completion of a batch, providing the Batch Manufacturing Record (BMR).

4.2 Sampling

1. QC personnel collect samples following the approved sampling plan and sampling SOP.
2. Label samples with product name, batch number, and date of sampling.
3. Store samples under appropriate conditions until testing.

4.3 Testing

• Conduct tests as per the product specification and Standard Test Procedures (STPs).
• Typical tests include:
• Physical characteristics (appearance, weight, volume, etc.)
• Chemical assays (potency, pH, etc.)
• Microbiological testing (if applicable)
• Record results in the Finished Product Test Report (FPTR).

4.4 Review and Approval

• Compare results against product specifications.
• If results meet all criteria, the batch is marked as “Approved”.
• If any parameter fails, initiate OOS (Out-of-Specification) procedure and mark as “Rejected” or “Under Investigation”.

4.5 Batch Release

• Submit complete testing records to QA for review.
• QA issues a Batch Release Certificate or Release Note for distribution.
• Store approved products in the Released Finished Goods Area.

4.6 Retention Samples and Documentation

• Retain samples of approved batches as per retention policy.
• File and archive all documents for traceability and audits.

5. References:

• Product Specifications
• Standard Test Procedures (STPs)
• Sampling SOP
• Out-of-Specification (OOS) SOP
• Batch Manufacturing Record (BMR)

6. Attachments:

1. Finished Product Test Report (FPTR) Template
2. Batch Release Certificate Format
3. Sample Labels (QC Approved / Rejected / Under Testing).

🎓 Discover one of the best Quality Assurance courses available — click below to explore the course that’s shaping future QA skills.

https://trcjw.on-app.in/app/oc/306166/trcjw