FDA Regulation and Inspection Guide


Are you a 503B trying to understand the FDA Regulation and Inspection Guide?  Do you feel like these guys?

I have a limited number of FDA Guidebooks that contain the FDA regulations 21 CFR parts 210 and 211 cGMPs in Manufacturing, Processing, Packing, or holding of drugs and finished pharmaceuticals AND the Drug Manufacturing Inspections: Compliance Manual for FDA Staff (7356.002) Drug inspections.

This guidebook is available to you free of charge and all you need to do to obtain one is to request it via our Contact Us Page.  If you cannot wait the FDA regulations 21 CFRF 211 are available here, the drug inspection guide is available here, and the sterile inspection guide is available here.

There is no reason to go into an FDA inspection blind to what the inspector will be looking for. For Example:

Did you know there are 6 quality systems that may be inspected?  And these systems encompass or address the following cGMP areas:

1) Quality System. This system assures overall compliance with CGMPs and internal procedures
and specifications. This system includes the quality control unit and all of its review and
approval duties (e.g., change control, reprocessing, batch release, annual record review,
validation protocols, and reports, etc.). It includes all product defect evaluations and
evaluation of returned and salvaged drug products. See the CGMP regulations, 21 CFR 211
Subparts B, E, F, G, I, J, and K.
2) Facilities and Equipment System. This system includes the measures and activities which
provide an appropriate physical environment and resources used in the production of the drugs
or drug products. It includes:

a) Buildings and facilities along with maintenance;
b) Equipment qualifications (installation and operation); equipment calibration and
preventative maintenance; and cleaning and validation of cleaning processes as
appropriate. Process performance qualification will be evaluated as part of the
inspection of the overall process validation which is done within the system where the
process is employed; and,
c) Utilities that are not intended to be incorporated into the product such a HVAC,
compressed gases, steam and water systems.

See the CGMP regulations, 21 CFR 211 Subparts B, C, D, and J.

3) Materials System. This system includes measures and activities to control finished products,
components, including water or gases that are incorporated into the product, containers and
closures. It includes validation of computerized inventory control processes, drug storage,
distribution controls, and records. See the CGMP regulations, 21 CFR 211 Subparts B, E, H,
and J.
4) Production System. This system includes measures and activities to control the manufacture
of drugs and drug products including batch compounding, dosage form production, in-process
sampling and testing, and process validation. It also includes establishing, following, and
documenting performance of approved manufacturing procedures. See the CGMP regulations,
21 CFR 211 Subparts B, F, and J.
5) Packaging and Labeling System. This system includes measures and activities that control
the packaging and labeling of drugs and drug products. It includes written procedures, label
examination and usage, label storage and issuance, packaging and labeling operations
controls, and validation of these operations. See the CGMP regulations, 21 CFR 211 Subparts
B, G, and J.
6) Laboratory Control System. This system includes measures and activities related to
laboratory procedures, testing, analytical methods development and validation or verification,
and the stability program. See the CGMP regulations, 21 CFR 211 Subparts B, I, J, and K.

For new facilities undergoing a first inspection, or facilities that have not consistenly demostrated compliance,  – the FDA will implement a full inspection option where at least 4 of the 6 above systems would be inspection – One of which MUST BE THE QUALITY SYSTEM.

You do not have to “go it alone”.  Performance Validation has over 30 years of working with FDA regulated companies to help insure compliance with the qualification of manufacturing equipment and the validation of manufacturing processes.  PV has assisted with and particiapted in FDA remediation following FDA inspections.  Need help? Have a question? Not sure where to start? Contact PV.