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Pharmaceutical QC lab checklist

1. Standard Operating Procedures (SOPs)

Ensure that all relevant SOPs for standard preparation and usage are current and accessible.

Confirm that all personnel are trained and familiar with the applicable SOPs.

Check that SOPs are followed consistently in the usage of working standards.

Verify that any revisions to SOPs are documented and communicated to the team.

2. Working Standard Preparation

Ensure that working standards are prepared according to the specified SOPs.

Confirm that the correct concentration and volume of standards are used.

Check that all reagents used in the preparation of standards are of appropriate quality.

Verify the labeling of working standards includes date of preparation, concentration, and analyst.

3. Standard Usage and Consumption Tracking

Ensure that a log is maintained for the consumption of all working standards.

Confirm that entries in the log include date, quantity used, and purpose of use.

Check that the consumption logs are reviewed regularly for discrepancies.

Verify that any unusual consumption patterns are investigated and documented.

4. Standard Storage and Stability

Ensure that working standards are stored under appropriate conditions as specified.

Confirm that expiration dates of standards are monitored and adhered to.

Check that any opened standards are labeled with the date of opening and user information.

Verify that stability studies are performed as necessary to ensure standard integrity.

5. Equipment Calibration and Verification

Ensure that all analytical equipment used for standard analysis is calibrated.

Confirm that verification procedures are in place for equipment performance.

Check that calibration data is documented and accessible.

Verify that any deviations in equipment performance are addressed promptly.

6. Quality Control Testing of Standards

Ensure that all working standards are subject to quality control testing before use.

Confirm that QC results for standards meet established acceptance criteria.

Check that any out-of-specification results are investigated and documented.

Verify that QC data for standards is reviewed regularly for trends.

7. Documentation and Record Keeping

Ensure that all records related to standard usage and testing are complete and accurate.

Confirm that records are stored securely and are easily retrievable.

Check that documentation complies with regulatory requirements.

Verify that any discrepancies in records are investigated and resolved.

8. Compliance with Regulatory Requirements

Ensure that all practices related to standard usage comply with regulatory guidelines.

Confirm that laboratory operations align with applicable Good Manufacturing Practices (GMP).

Check that all documentation is prepared for potential regulatory audits.

Verify that any regulatory changes are communicated and implemented promptly.

9. Personnel Training and Competency

Ensure that all personnel involved in standard preparation and usage are properly trained.

Confirm that training records include details of training dates and contents.

Check that competency assessments are conducted regularly for staff involved in QC activities.

Verify that ongoing training opportunities are available to keep staff updated.

10. Review and Continuous Improvement

Ensure that the standard operating procedures are reviewed periodically for effectiveness.

Confirm that feedback from chemists is gathered regarding standard usage and processes.

Check that improvement actions are documented and implemented based on reviews.

Verify that a culture of continuous improvement is encouraged within the QC lab.

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