Pharmaceutical quality is of vital importance.

Imagine getting a prescription from your doctor for drug X. You go to the pharmacy to pick it up, grab a bottle of water and then take the recommended dose hoping for the best because you have no idea what the quality of this bottle of drug X is!

This would includes not knowing if what you’re taking is:

  1. what it says on the label;
  2. safe for human consumption;
  3. effective;
  4. within a safe use-by date;
  5. of the correct strength;
  6. tested well;
  7. contaminated with microbes (anything else for that matter!)

*Merp*!

Thankfully, the FDA regulates these things (sigh of relief).

This is known as “CGMP” (Current Good Manufacturing Practice) or just “GMP” (Good Manufacturing Practice). 

What are CGMPs?

CGMPs are regulations that provide guidelines to ensure proper design, monitoring, and control of manufacturing processes and facilities.

CGMP is the main regulatory standard for ensuring pharmaceutical quality. This includes over-the-counter and prescription small-molecule drugs and biopharmaceuticals like vaccines, therapeutic blood products, gene therapies, antibodies and cell therapies (e.g. stem cell therapies).

In knowing that a company is adhering to CGMP regulations, we can rest assured that the identity, strength, quality, and purity of drug products have been tested to a high standard.

What does CGMP apply to within a company?

To follow CGMP includes establishing strong quality management systems, using good quality raw materials, implementing robust operating procedures, meticulously screening and investigating product quality deviations, and maintaining reliable testing laboratories.

Put simply, to follow CGMP a company must have:

  1. Facilities that are kept in good condition;
  2. Equipment that is carefully maintained and calibrated;
  3. Employees who are qualified and fully trained and;
  4. Operating procedures that are reliable and reproducible.

In order to reach these, a company may test for example 100 tablets for every batch of 2 million produced. It’s a careful balance between not testing so many that it’s just wasteful and needlessly arduous but testing enough that you can say with statistical strength that you’re as certain as you can be about the quality of the products you’re producing. After all, using drugs up for testing costs the company money but the public finding out that a product must be recalled because it’s unsafe and the corresponding PR nightmare and legal battles are far more costly!

What is the Difference Between CGMP and GLP?

A common misunderstanding is the difference between “GMP” and “GLP” (Good Laboratory Practice). However, the two are very distinct are illustrated below:

Similarities
  • Both are regulations governed by the FDA
  • Both are designed to ensure the safety and integrity of drugs
  • Both are given upon completion of 4 courses
Differences
GLP GMP
  • Less burdensome and costly to implement and maintain.
  • Applies to non-clinical laboratories.
  • Covers: personnel, testing facilities, equipment, testing and controls, records, reports, and protocol for and conduct of non-clinical labs.
  • Regulations were coded in 1978.
  • More burdensome and costly  to implement and maintain.
  • Based on International Conference on Harmonization of Pharmaceuticals for Human Use.
  • Applies to facilities producing products developed for use in or by humans.
  • Covers: facilities and buildings, equipment, production, process control, packaging and labeling, laboratory controls, and returned/salvaged drug and cellular products.
  • Includes: biological, biopharmaceutical, and pharmaceutical development and manufacturing industries.
  • Established in 1963.

In short, GMPs are for facilities making products intended to end up in or on you whereas GLP covers labs producing everything else.

Note: GMPs are not guidelines, they’re regulations. They are the MINIMUM STANDARDS that companies have to hit, not pie in the sky standards they strive to reach. They’re also very broad and allow for a lot of wiggle room. This gives companies some leeway in deciding how their particular product(s) and facilities should be designed and maintained to comply with GMP regulations.

What happens if a company doesn’t follow CGMPs?

If for example a drug falls short in the standards set because there is half the dose in each pill than was labeled, the FDA will advise the company to recall the product. It is very important to note that the FDA cannot force the company to do so. However it is in the company’s best interest to make sure its customers are safe. If a company refused to recall a drug, the FDA can issue a warning to the public, seize the product, and bring the company to court. Depending on the severity of the violation and the company’s response, the court case could result in fines and jail time.

You can read about some of the more recent and infamous GMP violations here (but it may make you pretty paranoid!)

Have you read of any companies who violated GMPs? How does your lab keep in line with GLPs & GMPs? Tweet us @TempoBioscience or comment below!

References:

FDA site explaining CGMP
A list of the FDA’s CGMP Regulations
More in-depth paper on GMP
Quick Summary on GMP vs. GLP