GMP and cGMP are two common and important terms used in pharmaceutical industry. As a pharmacist we should have clear knowledge on these terms to ensure current good manufacturing practices in pharma industries. Here we try to clear the difference between GMP and cGMP within practical knowledge and examples.


GMP

GMP stands for 'Good Manufacturing Practice'. It is ensuring that products are consistently produced and controlled according to quality standards.  It is also minimize the risks involved in  pharmaceutical production that cannot be eliminated through finished product testing.


 cGMP

cGMP stands for 'current Good Manufacturing Practice'. It is the update version of GMP. Where includes establishing strong quality management systems, available quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories.


GMP and cGMP in pharmaceutical industry (GMP vs cGMP)

  • GMP regulations are a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mixups, and errors.
  • cGMP reminding manufacturers that they must make use technologies and systems which are up-to-date in order to comply with the regulation. 

  • Failure to comply with GMP regulations can result in very serious consequences including recall, seizure, fines, and jail time.
  • Failure to comply with cGMP can result contamination, mixups, and errors.

  • GMP ensure the fundamental requrements of the company.
  • cGMP ensure the up-to-date technology and system of the company.


  • cGMP is more expensive when compared to GMP.
  • The compliance of quality with CGMP is more reliable when compared to the same of GMP.


Why C is small in cGMP?

A very common answer of this question is “c” is written in small letters as it is dynamic and it changes. On the otherhands “c” stands for “current,” indicates manufacturers make use technologies and systems which are up-to-date in order to comply with the regulation.


cGMP FDA

21 CFR Part 211 of US describes the 'Current Good Manufacturing Practices (cGMP)' for pharmaceutical industry. This is deemed to be dynamic, so that updated principles can be facilitated for implementation.


cGMP Examples

  • It is cGMP for a manufacturer to establish and follow written SOPs to operate and clean production equipment in a manner that precludes contamination of current and future batches.


The terms GMP and cGMP are somewhat interchangeable. Because technically, when systems are updated, and new regulations are put into place, the new ones become the current, i.e., cGMP. However, cGMP regulations always refer to the newest and updated technologies available at the time of manufacturing.


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