Standard Operating Procedure (SOP)

1. Purpose

This SOP describes the selection criteria and step-by-step procedure for choosing appropriate samples for dissolution profile studies to ensure accurate, reproducible, and scientifically justified results.

2. Scope

This procedure applies to all dosage forms (e.g., tablets, capsules) intended for dissolution profile studies in the [Department/Laboratory Name].

3. Definitions

• Dissolution Profile: The release pattern of the active pharmaceutical ingredient (API) from a dosage form over time under specified conditions.

• Sample Selection: The process of choosing representative units for the dissolution study to reflect batch uniformity and quality.

4. Responsibilities

• Analysts: Follow the procedure for sample selection and ensure documentation is accurate.

• Supervisors/Team Leads: Review and approve sample selection records before starting dissolution studies.

• Quality Assurance (QA): Ensure compliance with SOP and regulatory guidelines.

5. Materials and Equipment

• Sampling plan or batch record

• Analytical balance (calibrated)

• Sample containers

• Dissolution apparatus (USP I or II)

• Data recording templates or software

• Gloves and PPE as required

6. Procedure

6.1 Selection Criteria

• Samples must be representative of the entire batch.

• Select samples randomly unless otherwise specified (e.g., stratified sampling for critical lots).

• Include:

  • Beginning, middle, and end of the batch during manufacturing (if applicable).

  • Different manufacturing equipment lots, if multiple equipment were used.

  • Different container/closure systems, if applicable.

• Samples must be within the batch release specifications (e.g., weight variation, hardness, disintegration time).

Specific Considerations:

• For stability studies: Use stability-challenged samples.

• For validation studies: Use worst-case formulations if applicable (e.g., high/low API loads).

6.2 Number of Samples

• Follow pharmacopeial and regulatory requirements (e.g., USP, ICH):

  • Generally, 6 units for standard dissolution testing.

  • For detailed profile studies, 12 or more units may be selected to ensure statistical significance.

6.3 Sample Handling

• Handle samples with care to prevent any physical damage (e.g., chipping, abrasion).

• Store samples in labeled, appropriate containers under specified conditions until testing.

6.4 Documentation

• Record the following in the Sample Selection Record:

  • Batch number and manufacturing details

  • Sample ID numbers

  • Date and time of selection

  • Selected by (name and signature)

  • Any special conditions or observations during selection

• Attach the Sample Selection Record to the dissolution study file.

7. Precautions

• Always wear PPE when handling samples.

• Ensure that the samples are not exposed to humidity, light, or temperature variations before testing.

• Avoid bias in the selection process.

• Follow Good Laboratory Practice (GLP) at all times.

8. References

• USP <711> Dissolution

• ICH Q6A Specifications: Test Procedures and Acceptance Criteria

• FDA Guidance for Industry: Dissolution Testing of Immediate Release Solid Oral Dosage Forms

• Internal Laboratory Quality Manuals.

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