Standard Operating Procedure for Quality Control Testing and Release in Otic Manufacturing Unit
1) Purpose
To establish procedures for conducting quality control testing and releasing raw materials, intermediates, and finished Otic (Ear) Dosage Forms products to ensure compliance with specifications and regulatory requirements.
2) Scope
This SOP applies to all quality control testing activities, including raw materials, in-process samples, intermediates, and finished products within the Otic manufacturing unit.
3) Responsibilities
Quality Control (QC) Department: Responsible for performing testing, analyzing results, and making release decisions.
Quality Assurance (QA) Department: Responsible for oversight, review, and approval of quality control activities and release decisions.
Production Department: Responsible for providing samples and facilitating testing as per the production schedule.
4) Procedure
4.1 Sampling and Testing
4.1.1 Raw Materials
4.1.1.1 QC samples incoming raw materials according to sampling plan.
4.1.1.2 Conduct testing for identity, purity, and other specified parameters.
4.1.2 In-process Samples
4.1.2.1 Collect samples during critical stages of manufacturing (e.g., blending, granulation).
4.1.2.2 Test samples for compliance with in-process specifications.
4.1.3 Finished Products
4.1.3.1 Sample finished products as per sampling plan.
4.2 Analytical Testing
4.2.1 Test Methods
4.2.1.1 Use validated analytical methods for all testing activities.
4.2.1.2 Ensure equipment used is calibrated and maintained as per SOP.
4.2.2 Data Review
4.2.2.1 QC reviews test results for accuracy and compliance with acceptance criteria.
4.2.2.2 Document all results and observations in the appropriate records.
4.3 Quality Control Release Decision
4.3.1 Review and Approval
4.3.1.1 QA reviews all test data and documentation for completeness.
4.3.1.2 Approve or reject materials or products based on test results and compliance assessment.
4.3.2 Release Authorization
4.3.2.1 QA authorizes the release of materials or products that meet specifications.
4.3.2.2 Generate release documentation (e.g., Certificate of Analysis) and attach to batch records.
4.4 Retesting and Non-Conformance
4.4.1 Retesting
4.4.1.1 Conduct additional testing if initial results are inconclusive or out-of-specification.
4.4.1.2 Document reasons for retesting and results obtained.
4.4.2 Non-Conformance Handling
4.4.2.1 Initiate investigation for any non-conforming results.
4.4.2.2 Implement corrective and preventive actions as necessary.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance
6) Documents, if any
Certificate of Analysis template
Testing protocols and specifications
Non-conformance report form
7) Reference, if any
GMP guidelines for quality control testing and release in pharmaceutical manufacturing
8) SOP Version
Version 1.0