Guidance Documents

Good Manufacturing Practices Guidelines

Good Manufacturing Practices (GMP) are the part of quality assurance that ensures
that drugs are consistently produced and controlled in such a way to meet the
quality standards appropriate to their intended use, as required by the marketing
authorization

SUPAC guidelines are FDA guidelines for Scale-Up and Post-Approval Changes for manufacturing of drugs.

Collection of Process Validation, Cleaning Validation, Analytical Method Validation, Computer Validation Guidelines.

Our pick: Collection
of FDA Guidance Documents Organized by year from 1970