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.

This document describes the procedure for performing post marketing surveillance and market actions (i.e., recalls) affecting products cleared for commercial distribution by the firm. It creates the requirements and sets the responsibilities for appropriate functional groups during a product recall.

This document describes the steps for initiating, processing, and closing Quality Assurance (QA) Hold Reports associated with suspect non-conforming product or material. It allows for the quarantine of materials so that they can be investigated and given final disposition (approve or reject). This package includes the standard operating procedure (SOP) as well as the associated QA Hold Report form.

Procedure on how to disposition / release products and processes for various uses, including commercial release.

This document describes the process for the receipt, disposition, and release of raw materials used in or supporting GMP production at a manufacturing facility.  It covers the controls necessary for proper material flow and labeling as well.  This document can apply for pharmaceutical or medical device manufacturing firms.

This package contains two separate SOPs that work in conjunction with each other.  The first document is a general reagent and powder filling procedure.  It is appropriate for most manufacturers of chemicals, medical devices, or pharmaceuticals that have reagent or powder filling operations.  The second document is a hardware-specific SOP for the operation of an automated powder filling system (the Hierath & Andrews ISO-G 4104 Direct-Weight Filler). Note that these documents need to be customized and tailored to your specific operations, but do provide an excellent template/example for how these documents should be drafted.

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

Standard operating procedure describing how to analyze risk for products manufactured at the firm.  This document is more directed towards medical device manufacturers, but can be tailored for any type of product with inherent risks.

Procedure for creating an official record of signatures and initials for employees. This document is provided ABSOLUTELY FREE to see if you like our documents!

Operation of a Thermolyne Stir Plate. This is an SOP we provide ABSOLUTELY FREE to show our procedure template!

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

This document describes the procedures and requirements for the oversight of changes and the maintaining of adequate historical records of such changes from Third Party Manufacturers (TPMs) where API intermediates and API are manufactured and/or tested.

Procedure describing the process for qualifying and approving vendors and contractor operators for GMP operations at the firm.