Standard Operating Procedure for In-process Testing for Creams
1) Purpose
The purpose of this SOP is to outline the procedures for conducting in-process testing during creams production to ensure product quality, consistency, and compliance with specifications.
2) Scope
This SOP applies to all personnel involved in creams production, including production operators, quality control (QC) technicians, and supervisors. It covers procedures for conducting in-process tests at critical stages of creams manufacturing.
3) Responsibilities
It is the responsibility of production supervisors to oversee in-process testing activities, QC technicians to perform tests according to this SOP, and all production staff to follow defined procedures to maintain product quality.
4) Procedure
4.1 Sampling and Testing Frequency
4.1.1 Establish sampling plans based on production batch size and critical process parameters (CPPs).
4.1.2 Determine testing frequency for in-process samples, ensuring representative sampling throughout the production process.
4.1.3 Document sampling locations and procedures in batch records or testing logs.
4.2 In-process Testing Methods
4.2.1 Select appropriate testing methods based on the critical quality attributes (CQAs) of creams being produced.
4.2.2 Perform tests such as viscosity measurement, pH determination, active ingredient assay, and any other relevant tests specified in the batch record.
4.2.3 Use validated testing methods and calibrated equipment for accurate and reliable results.
4.3 Documentation and Recordkeeping
4.3.1
4.3.2 Document deviations from specifications and any corrective actions taken during testing.
4.3.3 Maintain traceability of samples and testing records for batch review and quality assurance purposes.
4.4 Reporting and Review
4.4.1 Review in-process testing results against acceptance criteria defined in batch records or specifications.
4.4.2 Report results promptly to production supervisors and QC personnel for review and approval.
4.4.3 Take appropriate actions based on test results, including adjustments to process parameters or additional testing as needed.
5) Abbreviations, if any
CPPs: Critical Process Parameters
CQAs: Critical Quality Attributes
SOP: Standard Operating Procedure
6) Documents, if any
Batch Records
In-process Testing Logs
Validation Reports for Testing Methods
7) Reference, if any
USP (United States Pharmacopeia) General Chapter on In-process Testing
ICH Q2: Validation of Analytical Procedures
8) SOP Version
Version 1.0
