GMP vs. non-GMP
What does cGMP mean?
cGMP refers to the current Good Manufacturing Practice regulations enforced by the U. S. Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act. The regulations are in 21 CFR, parts 210 and 211.
The purpose of these regulations is to assure the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. This would include strong quality management systems, robust supply chain management and risk mitigation, obtaining appropriate quality raw materials, establishing and validating operating procedures, detecting and investigating product quality deviations, and maintaining validated testing laboratories.
What are some of the requirements for a cGMP Manufactured Product?
The supplier of cGMP manufactured products must adhere to the following:
- FDA registration and inspection.
- Validated processes for manufacturing products along with impurity profiles for those products.
- Validated test methods.
- Stability testing and documentation of stability.
- QA (Quality Assurance) review of final QC (Quality Control) results.
- cGMP training for all employees.
- Packaging, handling, storage and distribution of the product, and a system to enable recall of a product when necessary.
- Traceability of raw materials.
- Yearly internal and external quality audits.
- Product sample retention and a system to manage them.
- Calibrated instrumentation with maintenance logs for critical or quality determining parameters.
- Comprehensive documentation.
Are cGMP Manufactured Products better than non-GMP Manufactured Products?
This question is not as simple to answer as it might seem, depending on one’s definition of “better.” If your definition is based on rigid compliance with processes and procedures, along with prolific documentation, then you might infer that cGMP manufactured products are “better” than non-cGMP manufactured products. But this is still not a simple comparison, especially for a manufacturer that follows cGMP practices and is ISO certified. Many of the requirements for ISO 9001 certification are also components of cGMP compliance.
Another aspect of your definition of “better” may have to do with analytical testing, such as the number of tests, impurity limits, test result tolerances, and test methods. Unlike ACS Reagent chemicals, which are listed in the Reagent Chemicals, Specifications and Procedures, 10th Edition, cGMP manufactured products do not always have a compendium to be tested against. As long as a manufacturer and their customer define the processes, properties, and results that are important to the customer, a cGMP manufactured product can have as many or as few analytical requirements as the customer deems necessary. ACS Reagent products have no requirements for how a product is manufactured, only requirements for analytical methods and results. cGMP products must be manufactured using documented, validated processes. Any deviation from these processes can cause the product to be considered “adulterated” and therefore be rejected, even if it meets all of the analytical specifications.
Why do cGMP Manufactured Products cost more than non-GMP Manufactured Products?
There are several things that add to the cost of most cGMP manufactured products. Among those are the requirements for QA review, process validation, stability studies, and recurring personnel cGMP training. In some cases, products that meet multiple compendial monographs may require more than 25 individual tests consuming 2-4 days of a technician’s time. cGMP products often require special packaging precautions such as tamper-evident seals, as well. As the saying goes, “Time is money,” and the more time needed to get a product out the door, the more it is going to cost.