Standard Operating Procedure (SOP) for Batch Production Record (BPR)

SOP Number: [Insert SOP Number]

Effective Date: [Insert Effective Date]

Review Date: [Insert Review Date]

1.0 Purpose:

This SOP outlines the procedures to be followed for the creation, review, approval, and maintenance
of Batch Production Records (BPRs) to ensure consistency, accuracy, and compliance with regulatory
requirements in the manufacturing process.

2.0 Scope:

This SOP applies to all personnel involved in the generation, review, approval, and maintenance of
BPRs within [Company Name] for all manufacturing activities.

3.0 Responsibilities:

The Production Department is responsible for creating and maintaining BPRs.

The Quality Assurance Department is responsible for reviewing and approving BPRs.

The Regulatory Affairs Department is responsible for ensuring compliance with regulatory
requirements.

4.0 Procedure:

4.1 Creation of BPRs:

BPRs shall be created by the Production Department in accordance with approved manufacturing
procedures and batch records.

BPRs should include information on raw materials, equipment, process steps, in-process controls,
and any deviations encountered during production.

4.2 Review of BPRs:

The Production Department shall review the BPR for accuracy and completeness before submitting it
for review.

The Quality Assurance Department shall review the BPR for compliance with cGMP (current Good
Manufacturing Practices) regulations, accuracy, and consistency.

4.3 Approval of BPRs:

BPRs must be approved by the Quality Assurance Department before the batch is released for
distribution or further processing.

The approved BPR should be signed and dated by the authorized personnel.

4.4 Maintenance of BPRs:

BPRs should be maintained in a secure and controlled environment to prevent unauthorized access
or alterations.

BPRs should be retained as per regulatory requirements and company policies.

5.0 Records:

All BPRs, including any revisions or updates, must be maintained as controlled documents in
accordance with company policies and regulatory requirements.

6.0 Training:

All personnel involved in the creation, review, approval, and maintenance of BPRs shall receive
training on this SOP as part of their onboarding and ongoing training requirements.

7.0 References:

[List any relevant references, documents, or regulations]

8.0 Revision History:

[List all revisions and their respective dates]