Standard Operating Procedure for Batch Record Review in Creams Production
1) Purpose
The purpose of this SOP is to define the procedures for reviewing batch records generated during creams production to ensure completeness, accuracy, and compliance with regulatory requirements.
2) Scope
This SOP applies to all personnel involved in the production, quality assurance, and quality control of creams. It covers the procedures for conducting thorough and systematic reviews of batch records before product release.
3) Responsibilities
It is the responsibility of QA personnel to review and approve batch records in accordance with established procedures. Production personnel are responsible for accurately documenting all activities and data in the batch records.
4) Procedure
4.1 Preparation for Batch Record Review
4.1.1 Retrieve the batch records from production upon completion of manufacturing activities.
4.1.2 Ensure all necessary documents and forms are available for review, including batch production records, in-process testing results, and packaging records.
4.1.3 Verify the completeness of batch records, including signatures, dates, and adherence to standard operating procedures.
4.2 Review of Batch Production Records
4.2.1 Verify the accuracy of information recorded in the batch records, including batch numbers, product identification, and manufacturing dates.
4.2.2 Cross-check raw material usage against the approved formulation to ensure correct quantities and adherence to specifications.
4.2.3 Review processing steps, including critical parameters such as mixing times, temperatures, and any deviations noted during production.
4.3 Review of In-Process Testing Results
4.3.1 Evaluate in-process testing data to ensure compliance with specifications and acceptance criteria defined in the batch record.
4.3.2 Investigate and document any deviations or out-of-specification results encountered during in-process testing.
4.3.3 Confirm that all required tests and inspections, such as pH, viscosity, and particle size analysis, have been performed and documented.
4.4 Review of Packaging and Labeling Records
4.4.1 Verify the accuracy of packaging and labeling operations against approved procedures and specifications.
4.4.2 Ensure all packaging materials used are traceable to the batch and meet regulatory requirements.
4.4.3 Review labeling for correctness, including product name, strength, lot number, and expiration date.
4.5 Compliance Assessment
4.5.1 Compare the reviewed batch records against established quality standards, regulatory requirements, and company procedures.
4.5.2 Identify any discrepancies, deviations, or non-conformances noted during the review process.
4.5.3 Communicate findings to production personnel for corrective actions and follow-up as necessary.
4.6 Approval of Batch Records
4.6.1 Document the review findings and any corrective actions taken in the batch record review report.
4.6.2 Obtain QA approval to release the batch for further processing, packaging, or distribution.
4.6.3 Maintain records of batch record reviews and approvals for regulatory inspections and internal audits.
5) Abbreviations, if any
QA: Quality Assurance
SOP: Standard Operating Procedure
6) Documents, if any
Batch Production Records
In-Process Testing Results
Packaging and Labeling Records
Batch Record Review Report
7) Reference, if any
ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
US FDA CFR (Code of Federal Regulations) Part 211: Current Good Manufacturing Practice for Finished Pharmaceuticals
8) SOP Version
Version 1.0