GMP Procedures (SOPs)

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

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

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

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!

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

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.

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.

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

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.

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.