Written By Adam Friend – Laboratory Analyst I
cGMP, cGLP, and ISO/IEC 17025 are different quality frameworks that exist to ensure laboratory work is reliable, controlled, properly documented and equipped to function as intended. The main differences between these systems primarily revolve around what each system is specifically designed to protect and control.
What is cGMP?
Current Good Manufacturing Practice or cGMP is built on the idea that pharmaceutical products need to be manufactured and controlled in a consistent manner that is in compliance with all appropriate quality standards. cGMP mainly controls equipment, personnel, production, packaging, quality control, documentation, and laboratory testing/ procedures.
Specifically in a contract laboratory setting, cGMP may not necessarily refer to the production of a physical product but rather the means by which quality testing is performed and results are obtained. The overall objective is to provide confidence that laboratory data used to make pharmaceutical quality decisions are reliable, traceable, and generated under appropriate controls.
What is cGLP?
Current Good Laboratory Practice or cGLP is primarily concerned with data integrity, accuracy, and reproducibility of laboratory studies, particularly studies that are geared around product safety in pre-clinical settings. cGLP controls things like study plans, SOPs, proper data handling, quality assurance and much more. The main goal of the cGLP quality system is to ensure that the entire life cycle of a study is documented correctly, and the data is generated and stored appropriately.
Specifically in a contract laboratory setting, cGLP is meant to make laboratory data in this space as trustworthy as possible. When a new drug is undergoing approval, nonclinical studies are run to evaluate properties like drug toxicity, pharmacology, absorption, metabolism, excretion, and overall safety among other things. cGLP regulations ultimately exist to protect the human users of newly developing drugs.
What is ISO 17025?
International Organization for Standardization 17025, or ISO 17025 refers to a specific standard titled General Requirements for the Competence of Testing and Calibration Laboratories. In an ISO 17025 regulated environment, emphasis is put on things like appropriate calibration, traceability, proper data handling, and overall technical competence. If a laboratory is ISO 17025 accredited, it means the laboratory has proven to a 3rd party accreditation body that it is technically competent to perform the specific tests within the defined scope of accreditation.
Specifically in a contract laboratory setting, ISO 17025 as a quality system is not specifically limited to pharmaceutical laboratories. It can apply to laboratories performing testing or calibration across many industries including pharmaceutical, medical device, environmental, food, materials, and many more.
Is cGMP, cGLP, or ISO 17025 more applicable to pharmaceutical laboratories?
cGMP is directly associated with pharmaceutical manufacturing and quality control. cGLP mainly applies to regulated laboratories doing nonclinical, or preclinical studies. ISO 17025 is primarily concerned with testing and calibration across a multitude of industries, and is often referenced in medical device applications. These frameworks are not simply alternatives to one another. For example, a laboratory performing routine quality-control testing on a pharmaceutical product may operate under applicable cGMP requirements. A laboratory performing a regulated preclinical toxicology study may operate under cGLP requirements. A contract laboratory performing technical testing may also maintain ISO/IEC 17025 accreditation to demonstrate its competence for specific testing activities. Laboratories can also follow multiple quality systems at the same time depending on the work that is performed.
Is one quality system more stringent than the others?
It is not accurate to say one quality system is inherently more stringent than another. Instead, it must be acknowledged that these systems are specifically designed for particular applications. The question to be asked is "Which quality requirements apply to the specific laboratory activity being performed?" There is overlap of these systems as well, especially with things like traceability and organization of records. However, each quality system is tailored to certain use cases which makes it difficult to compare how "stringent" one is compared to another. With that said, cGMP, with its scope intended for clinical and commercial pharmaceutical manufacturing and associated processes, including quality control testing, can often encompass and extend beyond general requirements for documentation practices found in ISO 17025.
How does CS Analytical apply these quality systems?
CS Analytical is the only cGMP, FDA-regulated laboratory built to serve the container and packaging testing needs of the pharmaceutical, biotechnology, medical device industries and more. CS Analytical uses the cGMP quality framework to provide standard and custom laboratory solutions that can be used for regulatory submissions and engagements. Whether it be USP/EP/JP physical performance and physicochemical testing, container closure integrity testing (CCIT), ISO medical device packaging or functionality testing, or more unique evaluations including ASTM and ISTA distribution, CS Analytical is committed to performing work in accordance with cGMPs, industry best practices, and regulatory expectations.