What are Pharmaceutical Current Good Manufacturing Practices (cGMP)?

Posted: June 16, 2022
Category: FDA,Regulation

What are Pharmaceutical Current Good Manufacturing Practices (cGMP)?

Compliance to and awareness of pharmaceutical Current Good Manufacturing Practices (cGMP) is critical for those working with these products or hoping to work with them. In this blog post we answer the 10 most common questions we are asked by new students who have never heard of cGMP.

Q.1 What are the Pharmaceutical cGMPs?

GMPs are the main regulatory standard for ensuring pharmaceutical quality. Also abbreviated as cGMP, the small “c” meaning “current”.

The aim of the cGMPs is to assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to cGMPS assures the identity, strength, quality, and purity of drug products. they requires that manufacturers adequately control manufacturing operations.

cGMPs are intended to be flexible to allow each manufacturer to decide how best to implement controls using scientifically sound design, processing, and testing. cGMPS represent the minimum requirements a manufacturer must follow.

To get an in dept understanding of the Pharmaceutical cGMPs, complete 21 CFR 210 / 211 CGMPs for Finished Pharmaceuticals Online Training Course.

 

Q.2 Why are Pharmaceutical cGMP is important?

Consumers cannot tell on their own that a drug (or device) will be safe and that it will work. Testing alone is not adequate to ensure quality. Most testing is destructive, so it’s not practical to test every tablet, pill, or vial as there wouldn’t be anything left for patients to use. It is therefore important that manufacturing happens under cGMP conditions to assure that quality is built into the design and manufacturing process at every step.

Complying with cGMP is a mandatory aspect of pharmaceutical manufacturing

Complying with cGMPs is a mandatory aspect of pharmaceutical manufacturing.

Q.3 Where do they come from?

They  come from the federal Food Drug and Cosmetic Act. (FD&C Act).

The FD&C Act was signed into law on June 25, 1938 by President Franklin D. Roosevelt. Gives authority to the FDA to oversee safety of food, drugs, and cosmetics. Chapter 5 covers drugs and medical devices.

cGMPs are spelled out in the Code of Federal Regulations (CFR). The CFR is the codification of the rules and regulations published by the U.S. federal government. The CFR represents areas subject to federal regulation. They cover everything from Agriculture, Banking, Highways, Labor, and Patents. There are 50 distinct chapters (titles) in the CFR. Food & Drugs is covered in Title 21 and document the actions required under federal law. Title 21 is the FDAs interpretation of the Food, Drug, and Cosmetics Act and related statutes.

Stop sign for GMP noncompliance

Q.4 Who enforces the cGMPs?

The cGMP regulations are enforced by the the Food and Drug Administration (FDA). The FDA also has very important law enforcement responsibilities. The agency employs civil and criminal investigators, auditors, attorneys, and other enforcement professionals. One of the FDA’ s many enforcement functions is investigation, remediation, and prosecution of cGMP violations.

To find out more about the FDA, complete Get to know the FDA Online Training Course.

To find out more about the FDAs cGMP enforcement acts, complete FDA Enforcement Acts Online Training Course.

 

Q.5 Why do we need them?

Manufacturers need to follow the cGMPs in order to  ensure that a safe and effective product is  manufactured. Adherence to cGMP requirements provides a high level assurance that medicines are manufactured in a way that ensures their safety, efficacy and quality.

 

Q.6 What do they apply to?

GMP applies to both Active Pharmaceutical Ingredients (APIs) and Finished Pharmaceutical Products (FPPs).

 

Q.7 What are the fundamentals of cGMPs?

(a) Quality Control, safety, and effectiveness must be designed and built into the product.

(b) Quality cannot be inspected or tested into a finished product.

(c) Each step of manufacturing must be controlled to maximize the chances that the Finished Good will be acceptable.

 

Q.8 What are the Benefits of cGMPs?

(a) They outline a Quality System that reduces or  prevents errors

(b) Ensures products are safe for use in humans

(c) Prevent/control contamination and cross-contamination

(d) Minimizes variations in potency of the drug

(e) Ensures reproducible physiological activity

(f) Prevent side effects and toxicity due to  variations in drug content and potency

(g) Prevents mislabeling and adulteration

 

Q.9 What are the building blocks of GMP?

The cGMPs require manufacturers to have adequately equipped manufacturing facilities, adequately trained personnel, precisely controlled manufacturing processes, appropriate laboratory controls, complete and accurate records and reports, appropriate finished product examination, and so on. Current GMPs are not “ best practices ” ; rather, they establish threshold or minimum standards which must be satisfied in order for a pharmaceutical manufacturing operation to be compliant.

 

Current GMPs are not “ best practices ”. They establish threshold or minimum standards which must be satisfied.

 

Q.10 Do you need to be trained on cGMP requirements if you work in the pharmaceutical industry?

Regulatory agencies around the world  require that training on GMP be conducted on a regular basis for those who are involved in  producing pharmaceutical and biological products. Documentation is also needed as evidence that the training occurred. More and more frequently, regulatory agencies and their inspectors are requesting evidence that the training was effective.

 

Conclusion

cGMP compliance is not an option. Quality should be built into the product. GMP’s are really good common sense and cover all aspects of manufacturing activities prior to supply. The role and involvement of senior management in maintaining GMP standards is crucial.

 

If you want to learn about cGMP requirements for pharmaceuticals check out our selection of courses on the topic: The Learning Reservoir Pharmaceutical Product Course Catalog

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    Dr. Fiona Masterson

    Fiona is the Managing Director and founder of The Learning Reservoir. Fiona has over 20+ years of experience in the Life Sciences, Food and Drink industries and third level education. Her Doctorate focused on the regulation of drug/device combinations products in the US and European Union. She has also published peer review publication on combination products.