cGMP EXAM QUESTIONS AND ANSWERS

What does CFR and HPFB stand for? What do they do? - Answer-CFR = Code of federal regulations HPFB = Health products and food branch set regulations that contain the minimum requirements for cGMP What is the goal of cGMP regulations? - Answer-To have a consistent process that will lead to a safe product that is of the quality and purity that it is purported to have What are the areas that must be compliant according to part 211 of cGMP regulations? - Answer-1) General Provisions 2) Organization and personnel 3) Buildings and facilities 4) Equips 5) control of components and drug product containers/closures 6) Production and process controls 7) Packaging and labeling control 8) holding and distributing 9) Lab cotrols 10) records and reports 11) returned and salvaged drug products What are the responsibilities of the Quality Control Unit? - Answer--Approve or reject all components (ex. materials, drug products, containers) -Review production records for errors What is dry labbing? - Answer-When contracted testing labs don't actually do the analysis How can dry labbing be prevented? - Answer--Retest critical analytes and compare to the certificate of analysis to make sure the variations correlate with the values on the certificate -Check baseline noise of chromatograms to make sure that they aren't identical What are some personnel qualifications? - Answer--Education, training, and experience -training must be done in cGMP by qualified individuals How can insufficient training be detected? - Answer-Inspectors will look at notes for errors which are indicators of lack of training What are some personnel responsibilities - Answer--Must be in clean, appropriate PPE -Can only enter authorized areas -Must not be in contact with drug or components if ill