This is a summary of a customer presentation I make frequently for work.

Good Laboratory Practice (GLP) is a set of requirements that provide a framework within which laboratory studies are planned, performed, monitored, recorded, reported and archived. GLP studies are performed to collect high-quality data and are commonly used in the field of safety pharmacology and to test medical devices. GLP applies to both in-vivo and in-vitro studies. GLP validation helps assure regulatory authorities that the data obtained by that system is a true reflection of the study results and can therefore be relied upon when making risk/safety assessments.

The basic concept behind GLP is that if trusted and proven methods are used to generate data, the data from those methods can be trusted as well. It sounds easy, but getting a system from 'untrusted' to 'trusted' can be difficult, depending on how stringently your Quality Assurance Department interprets the 21 CFR Part 11 and Part 58 regulations.

First, systems that are to be used to this standard must be validated to show they can produce accurate data reliably. The level of validation will depend of the nature of the system involved; off-the-shelf equipment is not as heavily scrutinized than a custom-built system or a specialized software package. Some common, off-the-shelf software packages or pieces of hardware are not even subjected to cursory validation prior to use because it is assumed that the vendor has performed this validation. This is usually reserved for very large, well-known vendors, regardless of their product quality.

Validation can take several forms. One common validation method uses known inputs to generate data, then compares the produced data to the expected outputs. Boundary conditions are also commonly tested, as are exceptions or possible error conditions. Writing useful validation scripts requires a good understanding of the system from a user's level. Most of the wasted time in system validations happens because the system is tested in too great detail; the FDA only expects a user-level validation.

After the system has been validated, all potential users must be trained in how to use the system correctly with the approved methods. Once trained, they can then use the system with the procedures they have been trained in. Every step of the process is heavily documented. The GLP laboratory's mantra is "If it isn't documented, it isn't done."

The FDA requires that GLP-produced data be available for review as long as the drug/medical device/etc is still commercially available. As a result, most GLP-produced data is retained indefinitely. Retaining this information in an easily accessible form is becoming a greater concern as time passes. Some companies retain ancient, unused systems for the sole purpose of providing access to previously collected data in case of a FDA audit. Other companies are developing migration and archival strategies to eliminate that need.

GLP is not appropriate for every study. The cost of running a study under GLP is approximately twice that of a non-GLP study of the same scope, and that figure does not include the cost of initial validation. Most of the additional cost is in extra person-hours, training, and documentation time. GLP studies are usually not done during early stages of pharmaceutical development (aka drug discovery). Later-stage feasibility studies are commonly done under GLP conditions; safety pharmacology studies are always done to a GLP standard.

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