What do we need to do to be certified as a GLP lab?

GOOD MANUFACTURING PRACTICE (cGMP) US FOOD AND DRUG ADMINISTRATION (FDA)
1

Dear colleagues,

How does a lab apply for GLP certification or establish a record of compliance?

I work for a small life sciences company with main focus on R&D, non-clinical efficacy and safety test studies of medical devices. The goal is to establish GLP compliant test facility (for internal use).

We already have started stepwise implementation of GLP requirements recommended in handbook for non-clinical R&D which makes a lot of practical sense even for “in house” record keeping.

What are the steps to gain official status?

Thank you,

2

Since you are in the FDA regulated industry, did you have a look at 21 CFR Part 58 - Good Laboratory Practice for Non clinical Laboratory Studies ?