SOP for Inspection of Nebulizer Batch Records

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

Detailed Inspection

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

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

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