1.0 Purpose:
1.1 This Standard Operating Procedure (SOP) outlines the procedure for creating Master Batch Records (MBRs) to ensure consistency and accuracy in the manufacturing process.
2.0 Scope:
2.1 This SOP applies to all personnel involved in the creation of MBRs within the manufacturing department.
3.0 Responsibilities:
3.1 The Quality Assurance (QA) department is responsible for overseeing the creation and approval of MBRs.
3.2 The Production Supervisor is responsible for providing the necessary information for MBR creation.
3.3 The Manufacturing Technician is responsible for drafting the MBR based on provided information.
3.4 The QA Manager is responsible for final approval of the MBR before it is implemented.
4.0 Procedure:
4.1 Gathering Information:
4.1.1 The Production Supervisor provides the Manufacturing Technician with the necessary information for the MBR, including product specifications, formulation details, and manufacturing instructions.
4.1.2 The Manufacturing Technician reviews the provided information to ensure completeness and accuracy.
4.2 Drafting the MBR:
4.2.1 Using the provided information, the Manufacturing Technician drafts the MBR document in accordance with company templates and formatting guidelines.
4.2.2 The MBR includes sections for product identification, formulation, manufacturing process, equipment requirements, and quality control procedures.
4.2.3 The Manufacturing Technician ensures that all information included in the MBR is clear, concise, and follows regulatory requirements.
4.3 Review and Approval:
4.3.1 Once the MBR is drafted, it is submitted to the QA department for review.
4.3.2 The QA department reviews the MBR to ensure compliance with regulatory requirements and company standards.
4.3.3 Any discrepancies or errors identified during the review process are communicated back to the Manufacturing Technician for revision.
4.3.4 Once all issues have been addressed, the QA Manager provides final approval of the MBR.
4.4 Implementation:
4.4.1 Once approved, the MBR is distributed to relevant personnel involved in the manufacturing process.
4.4.2 The Manufacturing Technician ensures that all personnel are trained on the contents of the MBR and understand their responsibilities.
4.4.3 The MBR is stored in a secure location to prevent unauthorized access or modification.
5.0 Documentation:
5.1 A copy of the approved MBR is maintained in the Quality Assurance department.
5.2 Any revisions or updates to the MBR are documented and approved through the same process outlined in this SOP.
6.0 References:
6.1 Relevant company policies and procedures.
6.2 Regulatory guidelines applicable to the manufacturing of pharmaceutical products.
7.0 Definitions:
7.1 MBR: Master Batch Record – a comprehensive document that provides instructions for the manufacture of a specific product batch.
8.0 Revision History:
8.1 Version 1.0 – Date: [Insert Date]
8.2 Version 1.1 – Date: [Insert Date] – [Brief Description of Changes]
9.0 Attachments:
[List any attachments relevant to this SOP, such as templates or forms.]
10.0 Approval: This SOP was reviewed and approved by:
Name: [QA Manager] Signature: ___________________ Date: [Insert Date]
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