1. In Warehouse
a. Control of Components and Drug Containers and Closures
i. Receipt and storage of untested components, drug product containers, and closures.
ii. Testing and approval or rejection of components, drug product containers, and closures.
iii. Use of approved components, drug product containers, and closures.
iv. Retesting of approved components, drug product containers, and closures.
v. Rejected components, drug product containers, and closures.
vi. Drug product containers and closures.
2. Make Tablets
a. Production and Process Controls
i. Written procedures; deviations.
ii. Charge-in of components.
iii. Calculation of yield.
iv. Equipment identification.
v. Sampling and testing of in-process materials and drug products.
vi. Time limitations on production.
vii. Control of microbiological contamination.
viii. Reprocessing.
3. Fill and Label
a. Packaging and Labeling Controls
i. Labeling issuance
ii. Packaging and labeling operations.
4. Package and cartons
a. Packaging and Labeling Controls
i. Materials examination and usage criteria.
ii. Packaging and labeling operations.
iii. Tamper-evident packaging requirements for over-the-counter (OTC) human drug products.
iv. Drug product inspection.
v. Expiration dating.
5. Testing
a. Laboratory Controls
i. Testing and release for distribution.
ii. Stability testing.
iii. Special testing requirements.
iv. Reserve samples.
v. Laboratory animals.
vi. Penicillin contamination.
6. Shipping
a. Holding and Distribution
i. Warehousing procedures.
ii. Distribution procedures
7. General and relatively short
a. Organization and Personnel
b. Buildings and Facilities
c. Equipment
d. Records and Reports
i. Equipment cleaning and use log.
ii. Component, drug product container, closure, and labeling records.
iii. Master production and control records.
iv. Batch production and control records.
v. Production record review.
vi. Laboratory records.
vii. Distribution records.
viii. Complaint files.
e. Returned and Salvaged Drug products
