GMP Procedures (SOPs)

Procedure on how to write and the requirements for standard operating procedures (SOPs).

Procedure on document change control.  Required to review and approve controlled documents.

Procedure on how to write and the requirements for forms used with SOPs and other controlled systems.

Procedure on how to keep records of personnel qualifications and training.

Procedure on how to write and the requirements for master batch records (production records) as well as the issuance of executable copies.

Procedure on how to perform audits and requirements for subsequent reports.

Procedure on how to write and the requirements for GMP-level protocols and reports.

Procedure on how to write and the requirements for logs and logbooks used to support controlled systems.

Procedure on how to receive, handle, and investigate customer complaints.

Procedure and policy on how to handle regulatory inspections. Includes the requirements for responses for regulatory agencies.

Procedure on technical change control. This manages technical (not simply one document) changes from overview standpoint.

Batch records are commonly also known as: production records, manufacturing records. Whatever your firm calls them, you need a procedure on how review such records and record that review. This procedure describes how to effectively review batch records and document the review on the appropriate forms. During the review of batch records, it’s helpful to have a checklist to guide you along the way.