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Gibraltar Laboratories, Inc is a CGMP, Current Good Manufacturing Practices, laboratory.  All operations of the laboratory are regulatory by this guidance.  In conjunction with 21 CFR Part 210 & 211, the Quality Assurance department is responsible for internally reviewing and auditing all testing conducted prior to release.  The Quality Assurance group being independent of the laboratory has the authority to reject reports in support of our customers as well as ourselves to assure quality and compliance. 

In collaboration with our Sponsor’s needs, Gibraltar Laboratories also provides GLP, Good Laboratory Practices, services. GLP testing includes all of the above CGMP and in addition is more thorough in its documentation and auditing. This type of testing is often requested when data is to be submitted to a regulatory body for approval such as IND, NDA, ANDA EPA disinfectant/sanitization registrations.  All study records are required to be maintained for the lifetime of the product and therefore additional regulatory scrutiny is likely for GLP studies

At the beginning of project, our Study Director prepares a protocol to detail all procedures planned. Testing cannot begin until both parties agree to its contents by formally signing the protocol.  At the conclusion of the study, a "package" of data will be included as part of the final report. 

Contrasting GMP reports, GLP final reports will additionally include copies of all raw data, certificates of calibration of equipment and an auditing checklist of testing. 

In some cases, GLP testing is requested based on a conservative philosophy or general theory of, “Better safe than sorry.”

Whether or not GLP testing is necessary or ultimately decided upon, Gibraltar Laboratories follows strict, rigorous and consistent time proven practices in regard to offering excellent, reliable and trustworthy testing services to the pharmaceutical, medical device, orthopedic, tissue bank, biopharmaceutical, chemical, and cosmetic industries in the areas of microbiology, chemistry and virology.