Drug or Pharmaceutical GMP SOP
A complete range of SOPs to comply with FDA drug 21 CFR 211 and Eudralex / orange guide pharmaceutical GMP regulations for the USA and Europe.
Includes risk approach and assessment, the quality management system requirements and responsibilities, prevention of contamination, complaints and recall, good distribution practice, and much more
Food or Dietary Supplement GMP SOP
A complete range of SOPs to comply with FDA 21 CFR 111 and European food and dietary supplement GMP regulations.
Plus our easy to use, detailed, step by step implementation plan for food or dietary supplement GMP which can also be used for internal audits, self-inspection and monitoring. Also serves as a good basis for drug and homeopathic drug compliance.
Laboratory GMP SOP
For drug and supplements, includes overviews of the chemistry, microbiology, and stability requirements; and sampling, specifications, and OOS investigations.
All laboratory test procedures comply with USP/EP and include a detailed report form that ensures consistency in records of chemicals, equipment, calibration, results, and calculations; eliminating common inspection deficiencies in lab notebooks from one analyst to another.
Key Features
We have provided for you a complete range of Standard Operating Procedures required for full compliance to all USA and EU Good Manufacturing Practice regulations and requirements for Drugs, Pharmaceuticals, Food, Dietary Supplements, or Cosmetics, including FDA 21 CFR 111, 21 CFR 211 and Eudralex; written by experts, and immediately available for you to download in Microsoft Word format.
Every SOP is automatically page numbered, indexed, includes a competency test to serve as a record of training, and are fully editable; you can add your company logo, change to your preferred company format, change to your business specific wording, or remove or add sections (provided you do not duplicate, send, sell or distribute the procedure outside the intended end use company address).
Search for a specific procedure on our site by either keyword, 111.x, 211.x, for USP by <xyz> or for EP by x.y.z
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