Assume you are a bioprocess engineer in a large company working on a
large volume biological compound (such as human insulin). Assume you
are working on its manufacture, process improvement, and development of
a second generation product). Please send your manager (Dr. Young) an
interoffice memorandum showing that you understand what information
you may need to be aware of at the following two regulatory internet sites.
This will be put in your file as supplemental documentation of training in
these areas (assuming it is of acceptable quality).
2 Pages Memo to me describe key US FDA Internet Reference (FDA.gov)
Information relevant to a Bioprocess Engineer.
What does FDA mean?
What is their function?
What does cGMP mean?
Also in a short paragraph for each item below, describe important
points noted in each item:
1. CFR 21 Part 211 – what is this and what are the subparts
2. Lookup Guidance for Industry #216 Chemistry, Manufacturing, and Controls (CMC) Information —Fermentation-Derived Intermediates …–what is this for and what are some of the sections that are relevant to a process engineer. Does this guidance apply to your project above?
3. Lookup Guidance for Industry, Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients (Drugs) – what is this for and what are some of the sections that are relevant to a process engineer. Does this guidance
apply to your project above?