The GMP 210/211 regulations address issues including recordkeeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling. Compiled and developed by John Cuspilich, Sr. Auditor for The Auditing Group.
GMP Publications Quality Compliance Publications Helping Companies Meet and Exceed FDA and Total Quality Management Standards.
This is a great training and information tool to provide all employees with the CFR requirements for the Food, Drug, Medical Device, Cosmetic, Healthcare, Electronic Records and Good Laboratory Practice.
US FDA Title 21 CFR Parts
Part 11 - Electronic Records/Electronic Signatures (ERES)
Part 210/211 - cGMP in Manufacturing, Processing, Packaging or Holding of Drugs and Finished Pharmaceuticals
21 CFR Part 820 - Quality Systems Regulations
QSR Audit Checklist
Medical Device Quality Systems Manual
For persons who purchased this item, you may also be interested in: GMP Auditor’s Basic Handbook