Guidance for Industry, Q7A Good Manufacturing Practice Guidance for Active
Pharmaceutical Ingredients. ... Quality Management (17.3); Repackaging,
Relabeling, and Holding of APIs and Intermediates (17.4) .... The stringency of
GMP in API manufacturing should increase as the process proceeds from early
API steps to ...
Keywords: Documentation and records, good manufacturing practices, quality
assurance ... Worldwide, there are different official regulatory statements and
guidelines, ... Manufacturing, Processing, or Holding Active Pharmaceutical
Ingredients. ... Any correction made to a document or record must be signed or
initialed and ...