SOP FOR BATCH RELEASE

Title: Standard Operating Procedure for Batch Release

Objective: To establish a standardized procedure for releasing batches of products for distribution or
further processing, ensuring compliance with quality and regulatory requirements.

Scope: This SOP applies to all personnel responsible for batch release at [Your Organization's Name].

Responsibilities:

[Name], [Job Title]: Responsible for conducting batch release.

[Name], [Job Title]: Responsible for reviewing and approving batch release documentation.

Procedure:

Batch Documentation Review

Describe the process for reviewing batch records, including production, testing, and quality
assurance documentation.

Quality Assessment

Explain the criteria and checks to be performed to ensure the batch meets quality standards.

Regulatory Compliance

Specify regulatory requirements that must be met before batch release.

Decision Making

Outline the process for approving or rejecting batch release.

Documentation and Archiving

Detail the process for documenting batch release decisions and archiving related records.

Communication
Explain how batch release information is communicated to relevant stakeholders.

Training and Competency

Define training and competency requirements for personnel involved in batch release.