cGMP Audits

QC2 offers the following  cGMP audits:

QC Laboratory Audits

Audits of QC laboratories to assess compliance with US FDA cGMP regulations, 21 CFR Parts 11, 210, and 211, United States Pharmacopeia-National Formulary (USP-NF), Electronic Records: Electronic Signatures, IEEE Software Development Life Cycle principles, and current industry concepts in computerized system validation.

Investigational Product Packaging and Labeling Facility Audits

Audits of investigational product (IP) packaging, labeling, and distribution centers and depots to assess compliance with applicable FDA regulations and guidelines, as listed in 21 CFR Parts 210 and 211 (drug cGMP regulations), 312, and 11, Electronic Records/Electronic Signatures, the FDA and ICH GCPs and cGMPs, IEEE Software Development Life Cycle principles, and current industry concepts in computerized system validation.

Depot / Distribution Audits

Audits of investigational product depot facilities including receipt, handling, storage, distribution, and inventory services to assess compliance with applicable FDA regulations and guidelines, ICH GCPs, and cGMPs.  Systems for returns and destruction are assessed, as applicable.

 

QC2 audits are customized for your specific project and budget needs.  We can provide assistance with all aspects of your projects, including audit plan consulting and development, audit scheduling, conduct, and reporting, and audit follow-up services (e.g., review of audit responses).  We conduct both general qualification audits and in-study audits.