Standard Operating Procedure for In-process Quality Control
1) Purpose
This SOP outlines the procedures for monitoring and controlling the quality of pharmaceutical products during the manufacturing process to ensure they meet specified standards and regulatory requirements.
2) Scope
This SOP applies to all in-process quality control activities conducted during the manufacturing of pharmaceutical products within the company.
3) Responsibilities
The Quality Control (QC) department is responsible for implementing and maintaining this SOP. The production staff is responsible for adhering to the in-process quality control procedures outlined in this SOP.
4) Procedure
4.1 Preparation for In-process Quality Control
- Review the batch production record (BPR) and identify critical control points (CCPs) for in-process testing.
- Ensure that all necessary equipment and materials are available and calibrated before starting the in-process tests.
4.2 In-process Testing
- Conduct in-process tests at specified intervals as outlined in the BPR. Typical tests may include weight variation, hardness, and uniformity of dosage units.
- Document all test results in the in-process control records (IPCR).
- Compare the results against predefined specifications to ensure they meet quality standards.
4.3 Handling Deviations
- Identify and document any deviations observed during in-process testing.
- Investigate the root cause of deviations and implement corrective actions to prevent recurrence.
- Record all deviations and corrective actions in the deviation report.
4.4 Final In-process Review
- Review all in-process test results and deviation reports at the end of the production batch.
- Approve the batch for further processing if all results meet the specified criteria.
- Quarantine and investigate the batch if any results do not meet the criteria.
4.5 Documentation and Records
- Maintain complete and accurate records of all in-process tests, results, and deviations.
- Ensure that all documentation is readily accessible for audits and reviews.
5) Abbreviations, if any
QC: Quality Control
BPR: Batch Production Record
CCP: Critical Control Point
IPCR: In-process Control Records
6) Documents, if any
Batch Production Records, In-process Control Records, Deviation Reports
7) Reference, if any
Regulatory guidelines such as FDA, EMA, ICH Q8 (Pharmaceutical Development), and ICH Q10 (Pharmaceutical Quality System)
8) SOP Version
Version 1.0
