Standard Operating Procedure for Batch Record Review in Aerosol Production
1) Purpose
The purpose of this SOP is to establish a standardized process for reviewing batch records in aerosol production to ensure accuracy, compliance, and completeness. This review ensures that all production steps were performed according to the approved procedures and that the final product meets quality standards.
2) Scope
This SOP applies to all batch records generated during aerosol production at [Company Name]. It includes the review of documentation related to raw materials, production processes, quality control tests, and final product release.
3) Responsibilities
Production Operators: Complete batch records accurately and promptly.
Quality Control (QC) Analysts: Verify test results and document them in batch records.
Quality Assurance (QA) Personnel: Conduct thorough reviews of batch records for compliance and completeness.
Production Supervisors: Ensure batch records are completed and submitted for review in a timely manner.
4) Procedure
4.1 Preparation for Review:
4.1.1 Collect all batch records and associated documents for the batch under review.
4.1.2 Ensure that all entries in the batch records are complete, legible, and signed by the responsible personnel.
4.2 Review of Production Records:
4.2.1 Verify that all raw materials used are listed, and their quantities match the Bill of Materials (BOM).
4.2.2 Check that production steps were followed as per the standard operating procedures (SOPs).
4.2.3 Confirm that any deviations from standard procedures are documented and justified.
4.3 Review of Quality Control (QC) Records:
4.3.1 Ensure that all QC test results are recorded and meet the specified acceptance criteria.
4.3.2 Verify the calibration status of equipment used for QC testing.
4.3.3 Review any out-of-specification (OOS) results and their investigation reports.
4.4 Review of Final Product Records:
4.4.1 Confirm that the final product meets all quality specifications and release criteria.
4.4.2 Ensure that the final product quantity matches the theoretical yield.
4.4.3 Verify the documentation of final product packaging and labeling.
4.5 Documentation and Approval:
4.5.1 Document any discrepancies or issues identified during the review in the batch record.
4.5.2 QA personnel approve the batch record by signing and dating the review section.
4.5.3 Forward the approved batch record to the appropriate department for archiving.
4.6 Recordkeeping:
4.6.1 Maintain batch records in a secure and organized manner as per the document retention policy.
4.6.2 Ensure that batch records are easily accessible for audits and inspections.
5) Abbreviations, if any
QA: Quality Assurance
QC: Quality Control
BOM: Bill of Materials
OOS: Out of Specification
SOP: Standard Operating Procedure
6) Documents, if any
Batch Records
Bill of Materials (BOM)
Quality Control (QC) Test Records
Deviation Reports
7) Reference, if any
GMP Guidelines
Pharmacopeial standards (e.g., USP, EP)
Regulatory Requirements (e.g., FDA, EMA)
8) SOP Version
Version 1.0
