Standard Operating Procedure for Inspecting Nebulizer Batch Records
1) Purpose
The purpose of this SOP is to establish a standardized procedure for the inspection of nebulizer batch records to ensure compliance with regulatory requirements and consistency in product quality.
2) Scope
This SOP applies to all batch records generated during the production, packaging, and quality control processes of nebulizers within the manufacturing facility.
3) Responsibilities
Production Team: Ensure complete and accurate documentation of batch records.
Quality Assurance (QA): Inspect and review batch records for completeness, accuracy, and compliance with SOPs and regulatory guidelines.
Documentation Control Team: Archive approved batch records for traceability and audits.
4) Procedure
4.1 Receipt of Batch Records
- Collect batch records from the respective production, packaging, and quality control teams at the end of each batch.
- Verify that all relevant sections of the batch records are included, such as production logs, equipment usage logs, and quality control test results.
4.2 Initial Review
- Check for the completeness of records, ensuring no sections or fields are left blank.
- Verify that all entries are legible, signed, and dated by the responsible personnel.
- Ensure that any corrections made in the records are properly documented, dated, and signed, as per Good Documentation Practices (GDP).
4.3
- Compare production data, such as raw material usage and yield, against the approved batch manufacturing instructions.
- Review quality control test results to ensure they meet the defined specifications and standards.
- Inspect equipment usage logs for proper calibration and maintenance records during the batch.
- Cross-check deviations or non-conformances reported during the batch and verify the implementation of corrective actions.
4.4 Approval Process
- Summarize findings in the Batch Record Inspection Report and categorize any issues as minor or critical.
- Discuss critical issues with the production and QA teams and ensure corrective actions are implemented before record approval.
- Approve the batch records only when all sections are complete, accurate, and compliant with SOPs and regulations.
4.5 Archiving of Records
- Stamp the batch records as “Approved” and forward them to the Documentation Control team for archiving.
- Archive records in a secure location with access restricted to authorized personnel.
- Maintain a Batch Record Index to ensure quick retrieval during audits or investigations.
4.6 Handling Non-Conformance
- Document non-conformance in the Batch Record Non-Conformance Report.
- Initiate an investigation and root cause analysis for critical issues and document findings.
- Ensure corrective and preventive actions (CAPA) are implemented and reviewed before closing the non-conformance.
5) Abbreviations
- QA: Quality Assurance
- GDP: Good Documentation Practices
- CAPA: Corrective and Preventive Actions
6) Documents
The following documents should be maintained:
- Batch Record Inspection Report
- Batch Record Non-Conformance Report
- Batch Record Index
7) References
Relevant regulatory guidelines and references include:
- ISO 13485: Medical Devices Quality Management Systems
- Good Manufacturing Practices (GMP) Guidelines
- Good Documentation Practices (GDP) Guidelines
8) SOP Version
Version: 1.0
Annexure
Annexure Title: Batch Record Inspection Report
Date | Batch No. | Inspection By | Issues Identified | Action Taken | QA Approval |
---|---|---|---|---|---|
DD/MM/YYYY | Batch Identifier | Inspector Name | Details of issues | Corrective actions taken | QA Name |
Annexure Title: Batch Record Non-Conformance Report
Date | Batch No. | Non-Conformance | Root Cause | CAPA | QA Approval |
---|---|---|---|---|---|
DD/MM/YYYY | Batch Identifier | Description of non-conformance | Root cause analysis | Corrective actions | QA Name |
Annexure Title: Batch Record Index
Batch No. | Product Name | Production Date | Archived By | Location | Remarks |
---|---|---|---|---|---|
Batch Identifier | Product Name | DD/MM/YYYY | Archivist Name | Storage Location | Additional details |