“Complete” seems like a simple unambiguous word. So why do so many firms struggle with complying with the following two predicate rules of cGMP compliance?
- 21 CFR 211.188 Batch production and control records (here)
“Batch production and control records shall be prepared for each batch of drug product produced and shall include complete information relating to the production and control of each batch.”
- 21 CFR 211.194(a) Laboratory records (here)
“Laboratory records shall include complete data derived from all tests necessary to assure compliance with established specifications and standards,