GMP Procedures (SOPs)

Procedure on how to write and the requirements for equipment performance qualification (PQ).

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

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

Procedure for handling deviations (also known as non-conformances) to controlled procedures.

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

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

This document describes gowning requirements for a manufacturing area. This procedure is appropriate for pharmaceutical, biopharmaceutical, chemical, and even medical device manufacturers / producers.

Procedure describing the issuance and tracking of laboratory notebooks.

Procedure on management reporting and quality review. Required by the FDA.

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

Procedure on reporting to the FDA for adverse events for medical devices. Required by the FDA for medical device manufacturers.

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