Understanding The 5 Elements Of cGMP
Current Good Manufacturing Processes (cGMP) are outlined by the FDA, which defines them as the “minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product.”
Together, cGMPs help ensure consumers get a product that’s safe to use, and that it has the ingredients, strength, and other elements that it claims to have.
At Andelyn Biosciences, we always follow all cGMPs required by the FDA to maintain product safety, so let’s discuss the basic elements of cGMP, also known as the or “5 Ps” of CGMP.
The 5 Ps Of CGMP – What You Should Know
Obviously, the full requirements and regulations related to CGMP are too complex to explain in full here. But there are 5 basic elements that go into it, which we’ll discuss briefly now.
- Products & Materials – All products and raw materials must have specifications and requirements for safety for each part of the production process, and must be tested and for quality, with records kept to ensure product quality and safety. This is important because it ensures proper overall quality and functionality of the end product – and allows potential production issues to be recognized quickly.
- Premises & Equipment – Premises and equipment must meet requirements for safety, sanitation, and preventing cross-contamination, and must be maintained, cleaned, and used properly. Records, schedules, and other information must be kept about their use to verify compliance. This also helps to help track the source of any issues found in products.
- People – All people working on a product must have clear roles and responsibilities, follow all procedures properly, and be properly trained for the work that they are doing. This ensures safety issues caused by poor training or compliance are avoided.
- Procedures – All procedures must be properly recorded and documented, and all critical processes must be covered. They must be properly followed, and any deviations from normal procedures must be documented, investigated, and reported to make corrections, if necessary. This is important because it helps eliminate human error during the production process.
- Processes – All processes used to produce a product must be clearly defined, consistent, validated, and safe. Critical steps must be identified, and change control procedures must be in place to ensure that processes are not changed without fully understanding the impact this may have on product production.
What Is The Purpose Of The “5 Ps?”
In a word? Safety. Especially for pharmaceutical products, safety is of the utmost importance when creating any kind of product for medical use – from basic drugs like aspirin to complex products like AAVs for gene therapy.
The elements of cGMP outline safety procedures for every basic part of the production process – defining what needs to be done to keep products safe, to operate machinery properly, to validate processes, to maintain consistent procedures, and so much more.
These regulations, when properly followed and adopted by drugmakers and other pharmaceutical and biopharma companies, ensure that everyone is operating with safety in mind – and is creating high-quality products that will function properly and effectively in a medical environment.
We Use cGMP In Our Clinical Manufacturing Facility At Andelyn Biosciences
At Andelyn Biosciences we use cGMP when creating viral vectors and in all other aspects of the services we provide at our clinical manufacturing facility. If you need assistance developing AAVs for gene therapy or have any other type of biopharma project, we’d be happy to hear from you and discuss your needs in further detail. Contact us today to get started and get the assistance you need from our team.