What is GMP?
GMP is an abbreviation for the Good Manufacturing Practice regulations for Drugs/Finished Pharmaceuticals. It is often referred to as CGMP where “C” denotes “current”.
What are the GMP Regulations and Why Do They Exist?
The GMP regulations establish a minimum set of requirements governing the manufacturing, processing, packing, labeling, testing, and holding of drug products to assure that they are safe, and have the identity, strength, quality and purity characteristics that each purports or is represented to possess.
Why do the GMP Regulations Apply to Sunscreen Products?
Sunscreen products are classified as drug products within the USA and in many countries around the world. This is based on the fact that sunscreen products make claims of protecting the user from harmful effects that the sun’s UV radiation may have on the human body. Here in the USA, sunscreen products fall into either of two categories of drugs:
*Over-the-counter (OTC) Drugs which are manufactured in accordance with the GMP regulations and are formulated, tested and labeled in accordance with the OTC Drug Monograph for sunscreen products as published within the Code of Federal Regulations.
*Prescription Drugs which are manufactured in accordance with the GMP regulations and have received FDA approval as a new drug.
What are some of the Major GMP Requirements for OTC Sunscreen Products?
*Manufactured in an FDA-registered, GMP-compliant facility.
*Manufacturing and Cleaning processes are validated.
*SPF value has been determined within a GMP-compliant testing laboratory.
*Analytical testing procedures are validated.
*Expiration dating established in each marketed container per FDA/ICH Guidelines.
*Annual Product Reviews are conducted.
How does GMP Compliance affect me if my Sunscreen Product is Manufactured for me by a CMO?
The owner of a drug product is legally responsible for ensuring its safety and compliance with all applicable GMP requirements, even if it is manufactured by a CMO. This is why CMO’s should be carefully selected, qualified, and regularly monitored to ensure their continued compliance with GMP.
Your CMO’s compliance record directly affects the compliance with your product, so it is in your best interest to actively monitor the manufacturing of your Sunscreen product and all testing that is conducted upon it.