GMP Procedures (SOPs)

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

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.

This document is an example Batch Record Review checklist.  It provides a proper template for how a well-designed checklist could work.  We recommend this document in conjunction with our Batch Record Review SOP.

Certificates of Analysis are required documents for most batches to be QA Released by an organization. This product contains 2 templates for a Certificate of Analysis. The first document is just a blank template/shell for a properly and cleanly formatted CofA. The second document is a filled in example template with example tests and result specifications for a typical biopharmaceutical product.

Procedure identifying the responsibilities and requirements for performing QA audits of operations related to the items that the firm/function oversees. This audit procedures applies to a higher / “corporate” level of oversight.

Procedure on corrective and preventative actions (CAPAs). Covers how to investigate for root cause, tracking of implementation of correction actions, and closure.

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

Procedure on how to write and the requirements for equipment installation qualification (IQ) protocols.

Procedure on how to write and the requirements for Item Specifications.

Procedure on how to write and the requirements for simple list documents.

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

Procedure on how to write and the requirements for equipment operational qualification (OP) protocols.

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.