📋 Procedure for Sampling in Process Validation

1. Preparation Stage

• Review the approved Process Validation Protocol for sampling details (points, number of samples, method).

• Ensure that sampling tools and containers are clean, calibrated, and labeled.

• Train personnel involved in sampling to avoid cross-contamination and errors.

2. Identification of Sampling Points

• Define critical process stages where variability can impact product quality.

• Typical sampling stages include:

  • Raw materials and intermediates

  • Blend uniformity (beginning, middle, end of batch)

  • Granulation (wet & dry samples)

  • Compression / encapsulation (in-process checks at intervals)

  • Coating samples at different stages

  • Final product sampling

3. Sampling Methodology

• Use statistically justified sampling plans (e.g., stratified random sampling).

• Follow specific SOPs for each dosage form (solid, liquid, semisolid, parenteral).

• Collect samples in triplicate where required (e.g., content uniformity, blend uniformity).

• Ensure that sampling does not affect the integrity of the batch.

4. Sample Handling and Labeling

• Transfer samples into clean, labeled containers (with batch number, date, stage, sampler’s initials).

• Protect samples from light, moisture, and contamination.

• Maintain chain of custody for traceability.

5. Documentation

• Record sampling activity in Batch Manufacturing Record (BMR) or validation logbook.

• Include details such as:

  • Sampling date and time

  • Process stage

  • Equipment used

  • Quantity sampled

  • Sample location/point

  • Personnel signature

6. Testing and Analysis

• Send samples to QC for analysis as per the validation protocol (e.g., assay, dissolution, uniformity, microbiological tests).

• Compare results with acceptance criteria defined in the protocol.

7. Review and Reporting

• Compile test results and sampling records in the Process Validation Report.

• Investigate deviations or OOS results, if any.

• Conclude whether the process is capable of consistently producing quality product.

✅ Key Principles

• Sampling must be representative of the batch.

• Must follow Good Manufacturing Practices (GMP).

• Should be scientifically justified and documented.

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