Differences between GMP and GLP are important to understand for professionals who work in areas which involve these two different, yet related practices. Since the two appear somewhat similar in terms of their application and nomenclature; there is considerable scope for misunderstanding and confusion.
It is necessary to understand the nature of the differences between GMP and GLP because those who are involved in these two practices have different roles to perform in the course of their work.
Differences between GMP and GLP are pronounced in laboratory testing
The differences between GMP and GLP are pronounced in laboratory testing, in which they serve different purposes.
This is how one can understand the differences between GMP and GLP: While GLP is concerned with preclinical development; GMP is related to manufacturing. In other words, GLP is based on study, while GMP is based on process.
Another area of understanding the differences between GMP and GLP is that the chief purpose behind designing GMP is to show to the regulatory bodies such as the FDA or the EPA whether or not individual lots or batches of any regulated manufactured product have met the criteria for manufacturing set out by these agencies.
On the other hand, the core purpose of GLPs is the protection of the integrity of scientific data. They are meant to provide regulatory agencies with data that helps the agencies scrutinize and audit the scientific validity of research studies.
Not so clear-cut in the areas of validation
However, the differences between GMP and GLP are not so clear-cut in the area of the application of validation. There is some lack of clarity on which areas of validation studies should be done under GLP and which, under GMP. When it comes to this area, it all depends on what is being validated. This factor dictates whether it is a GMP or a GLP is to be applied, based on what the professional considers appropriate for the occasion.
GMP precedes GLP
The fact that GMP precedes GLP is a commonsensical way of understanding the differences between GMP and GLP. Generally, GMP governs the earlier stage of testing. The testing of release lots and the proof of their conformity to standards set out by the regulatory bodies are done by GMP.
The next stage of this process, namely the testing of these products’ safety and efficacy, is done as part of GLP. This is another aspect at which the differences between GMP and GLP can be highlighted.
A learning session
Compliance4All, a leading provider of professional trainings for areas of regulatory compliance, will be organizing a webinar, at which the differences between GLP and GMP will be explained. Joy McElroy, a senior professional in the pharmaceutical industry, will be the speaker at this learning session.
To enroll for this webinar, just visit http://www.compliance4all.com/control/w_product/~product_id=501116LIVE/~sel=LIVE/~Joy_McElroy/~GLPs:_How_are_they_Associated_with_GMPs_and_SOPs
At this webinar, while explaining the difference between GLPs and GMPs and how they are associated with SOPs; Joy will cover the following areas:
o What are Good Laboratory Practices
o Why were they created
o What is the objective of GLPs and how are they associated with GMPs and SOPs
o Statistical Procedures for data Evaluation
o Instrumentation Validation
o Analytical and laboratory Certification
o Documentation and Maintenance of Records
o Consequences of Noncompliance
o Disqualification and Reinstatement