Why hire GxP Compliance Consultants?
To answer this question, one first needs to know what GxP is. The “G” stands for “Good,” and the “P” stands for “Practices.” The “x,” just as in mathematics, is a variable—it can stand for many things. Like mathematics, the trick is to “solve for x.” That’s where Compliance Team’s GxP consultants can help.
Here are few possible solutions for x:
GMP: Good Manufacturing Practices—Depending on the product manufactured, the regulation for GMP will differ.
21 CFR 210/211 (GMPs for Finished Pharmaceuticals)
21 CFR 110 (GMPs for Human Foods)
21 CFR 111 (GMPs for Dietary Supplements)
GLP: Good Laboratory Practices—These are the best practices for laboratory testing, in 21 CFR 58.
GCP: Good Clinical Practices—The standards for ensuring safe clinical trials that yield unbiased, truthful information. Numerous standards apply here, including 21 CFR parts 50, 58, 312, 320, 511, and 812.
GDP: This is not Gross Domestic Product, but can mean two things:
Good Documentation Practices—Requirements for ensuring that documentation meet the ALCOA principle: Documentation is Attributable, Legible, Contemporaneous, Original, and Accurate. 21 CFR Part 11, Annex 11 (Europe) and the GDP Guidance.
Good Distribution Practices—Standards for ensuring that products are stored, shipped, and identified during transit so they safeguarded from adulteration. The standards for distribution include VAWD, & DSCSA for drugs, and the UDI Final Rule for medical devices.
That’s where GxP Compliance Consultants can help your team make sure they are on top of the latest regulations and requirements.
The regulations cannot be implemented at face value, in fact they are worded vaguely to allow flex as the state-of-the-art in the subject area evolves. For example, 211.58 states, “Any building used in the manufacture, processing, packing or holding of a drug product shall be maintained in a good state of repair.” A layperson may not know how to implement this rule into a meaningful standard, because what constitutes “a good state of repair”? A Consultant can assist the company with how to convert this vague statement into tangible requirements.
In fact, GxPs are often referred to as cGxP. The little “c” in front stands for “current.” That little “c” is a reminder that the GxPs change over time, as the state-of-the-art for a particular technology evolves. For example, laboratory instruments are now built with controlled logins, unique to individual equipment users. In the past, instruments may have been built to enable a single “departmental” login, or no logins at all. The Current GLP expects a unique login and password for each authorized user.
Why talk with Compliance Team’s GxP Compliance Consultants?
Compliance Team will provide a subject-matter expert who can relate to your business challenges and help you achieve your GxP compliance goals. The expert we assign will understand the subject area and identify the GxP standards suit the situation. Then, our experts can perform a gap assessment to find the highest-impact areas for focus, based on gap size and its relative importance. Compliance Team GxP Compliance Consultants will then customize a plan to help your team meet their GxP goals and requirements.
Let us know a little more about your specific goals.