Batch Manufacturing Record Procedures for MDIs

1) Purpose

The purpose of this SOP is to establish procedures for maintaining batch manufacturing records (BMRs) for metered-dose inhalers (MDIs) to ensure accurate documentation of production processes, traceability, and compliance with regulatory requirements.

2) Scope

This SOP applies to all personnel involved in the preparation, review, and maintenance of BMRs within the MDI production facility, including production supervisors, quality assurance personnel, and documentation specialists.

3) Responsibilities

The responsibilities for this SOP include maintaining accurate BMRs, documenting production activities, verifying data accuracy, and ensuring compliance with SOPs. Specific roles include:
Production Supervisors: Oversee BMR completion and review for accuracy and completeness.
Quality Assurance Personnel: Verify BMRs against batch records and approve for product release.
Documentation Specialists: Maintain BMR documentation and ensure archival according to regulatory requirements.

4) Procedure

4.1 BMR Preparation
4.1.1 Initiate BMR documentation at the start of batch manufacturing.
4.1.2 Include batch details, formulation specifications, and process parameters in the BMR.
4.2 Recording Production Activities
4.2.1 Document each step of the manufacturing process, including material reconciliation and equipment used.
4.2.2 Record in-process testing results, deviations, and any corrective actions taken during production.
4.3 Review and Approval
4.3.1 Review completed BMRs for accuracy and compliance with SOPs and specifications.
4.3.2 Obtain approvals from designated personnel (e.g., quality assurance) before batch release.
4.4 Archival and Documentation
4.4.1 Archive BMRs according to regulatory requirements for future reference and audits.
4.4.2 Maintain electronic and/or physical copies of BMRs in a secure and accessible manner.

5) Abbreviations, if any

MDI: Metered-Dose Inhaler
SOP: Standard Operating Procedure
BMR: Batch Manufacturing Record

6) Documents, if any

Batch manufacturing record templates, completed BMRs, in-process testing results, and batch release certificates should be maintained.

7) Reference, if any

Refer to regulatory guidelines from agencies such as the FDA, EMA, and ICH for BMR requirements in pharmaceutical manufacturing.

8) SOP Version

Version 1.0