Analysis & QC
cGMP – Good Manufacturing Process
cGMP (Good Manufacturing Practice)
Good manufacturing practices (GMP) are the step-by-step activities needed to comply with the guidelines to provide an audited log of each step of the manufacturing process. GMP guidelines provide a minimum standard to mitigate any error during any step of the manufacturing process.
The main purpose of GMP guidelines is to produce an audited log of each step of the manufacturing process and prevent harm from occurring to the end-user.
Why use cGMP?
To provide a system that ensures that proper monitoring and quality control are enforced during the manufacturing process.
Factories that follow cGMP test and log the identity, strength, quality, and purity of the products that they produce in a traceable manner. In the event of any unexpected occurrence during the manufacturing process, cGMP guidelines provide a traceable log that will allow the manufacture to pinpoint the occurrence within the manufacturing process.
cGMP mainly entails the following quality-focused operations:
- • Management Systems
- • Quality Raw Materials
- • Operating Procedures
- • Detecting Deviations
- • Investigating Deviations
- • Reliable Testing
- • Batch related numbering system
cGMP vs GMP
The “c” stands for “current”, meaning that manufacturers are required to stay up to date with their systems and technologies. For example, testing equipment and machines used to prevent contamination may have been first rate 20 years ago but have been replaced by more reliable equipment.
Why does cGMP matter?
The end customer is not able to detect if a chemical was contaminated during the production or packaging phases by using their senses and opinions. An audited log of production, testing, and handling of each chemical provides the customer with assurance of quality.
While, it is extremely important and required by cGMP that testing is done on all products, testing alone is not enough to ensure quality. As in most cases, testing is only conducted on a small sample of a production run (for example, a manufacturer may only test 100 tablets from a batch of 1 million). Hence, all products must be manufactured in conditions and practices that comply with cGMP to assure that quality is built into the design and manufacturing process at every step.
In addition to the extensive testing methods that cGMP requires, high standards of sanitation, property conditions, equipment must be properly maintained and calibrated, the employees have received the correct safety and production training, and that each process has a verification process.
If you have any questions regarding cGMP, please contact us.