Standard Operating Procedure (SOP)

Here’s a comprehensive Standard Operating Procedure (SOP) for the Testing, Release, or Rejection of Finished Product. This SOP ensures quality control and compliance with industry regulations (e.g., pharmaceutical, cosmetic, food, or chemical manufacturing).

1. Purpose

To outline the procedure for sampling, testing, and determining the release or rejection of finished products to ensure they meet predefined specifications and regulatory requirements.

2. Scope

This SOP applies to all finished products manufactured at [Company/Plant Name] and covers sampling, testing, release, and rejection processes.

3. Responsibilities

• Quality Control (QC): Responsible for sampling and testing finished products.

• Quality Assurance (QA): Responsible for final review and approval of release or rejection.

• Production: Responsible for notifying QC upon batch completion and ensuring sample availability.

• Warehouse: Responsible for holding finished products under quarantine until release.

4. Definitions

• Finished Product: A product that has completed all manufacturing stages and is ready for packaging or dispatch.

• COA: Certificate of Analysis

• Quarantine: Status assigned to products awaiting QC approval.

5. Materials and Equipment

• Sampling tools (sterile scoops, containers, etc.)

• Laboratory instruments (HPLC, GC, balance, etc.)

• Approved specifications and test methods

• Logbooks and sample labels

• Computer systems for documentation (e.g., LIMS)

6. Procedure

6.1 Sampling

1. QC receives notification of batch completion from production.

2. Collect samples as per sampling plan (random, stratified, or statistical method).

3. Label samples with product name, batch number, date, and sampler initials.

4. Store samples under specified conditions until testing.

6.2 Testing

1. Perform testing in accordance with the approved specifications and validated methods (e.g., appearance, pH, assay, microbial limits, etc.).

2. Record all raw data and results in laboratory notebooks or electronic systems.

3. Review test results against product specifications.

4. If out-of-specification (OOS) results occur, follow the OOS SOP for investigation.

6.3 Release

1. Prepare Certificate of Analysis (COA) upon successful test completion.

2. QA reviews test reports, COA, and batch records.

3. If compliant, QA releases product by signing batch release form and updating inventory status to “Released”.

4. Notify warehouse and production of product release.

6.4 Rejection

1. If test results do not meet specifications or batch fails investigation:

   • Document reason for rejection.

   • Label product as “Rejected” and segregate it.

   • Initiate non-conformance report (NCR) and follow corrective action procedures.

2. Inform relevant departments (QA, production, warehouse).

7. Documentation

• Sampling logs

• Test reports

• COA

• Batch manufacturing records

• Non-conformance or deviation reports

• Final release or rejection form

8. Precautions

• Ensure all sampling and testing is done in accordance with GMP.

• Prevent cross-contamination during sampling.

• Handle rejected materials securely to prevent unintended use.

9. References

• Product specifications

• Good Manufacturing Practices (GMP) guidelines

• SOP for Out-of-Specification (OOS) Results

• Equipment calibration and validation records.

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