211.25
personnel qualifications
211.28
personnel responsibilities
211.42
specific requirements for aseptic processes
210.3
gang-printed labeling: mass printing of labels for more than one item
cut labels - special restrictions
100% = electromechanical inspection after application
200% = visual inspection for hand-applied labels
Biologics Control Act
- 1902
- because of tetanus contaminated smallpox vaccine from horse
- pre-market approval for biologics
Pure Food and Drugs Act
- 1906, also Wiley Act
- first federal law to regulate food and drugs
- prohibits interstate commerce in misbranded and adulterated food, drink, and drugs
FFDCA
- 1938
- due to elixir sulfanilamide crisis (solvent = highly toxic antifreeze)
- prove products are safe before marketing
- first use of good manufacturing practices
Kefauver-Harris Amendments
- 1962, to FFDCA
- due to morning sickness sedative, thalidomide
- use of cGMPs became prevalent
- must prove safety and efficacy before FDA approves commercialization
FDA Amendments Act
- 2007
- post-market surveillance
211.89
Reject in process materials = quarantine
211.103
Calculation of yields
211.105
Equipment identification
211.182
Equipment logs
211.111
Time limitations on production
211.113
Control of microbial contamination
211.192
Production record review and disposition
211.196
Distribution records
211.192
Annual review of records
211.115
Reprocessing
major change control
affects product process, facility systems, or equipment process (ex. incubation time would affect product quality)
minor change control
impact some of the process but not the final product characteristics (ex. new equipment affects production time but not product)
critical change control
alters product all together and/or impacts product process quality (ex. product formulation change)
211.142
Warehouse Procedures
