GMP Procedures (SOPs)

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!

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.

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 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 logs and logbooks used to support controlled systems.

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

Procedure describing the issuance and tracking of laboratory notebooks.

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 keep records of personnel qualifications and training.