Study Set Content:
Equipment should be Suitably located to facilitate:
Intended use – Cleaning – Maintenance
Standard operating procedures must be
written and followed
That describe the receipt, identification, storage, handling, sampling, testing, and approval or rejection of all drug product components, product containers, and closures must be maintained and followed
Written procedures
Written procedures.
Production and Process Controls
• Ensure correct identity, strength, quality, and purity.
Production and Process Controls
Any deviation must be recorded and justified.
Production and Process Controls
All product ingredients, equipment, and drums or other containers must be distinctively identified.
Production and Process Controls
to ensure that the drug product meets applicable standards at the time of use
Expiration dating
November 5, 1982
Tamper-evident packaging
Have one or more indicators or barriers to entry which, if breached or missing, can reasonably be expected to provide visible evidence to consumers that tampering has occurred
Tamper-evident packaging
Written procedures
Control of Components, Containers, and Closures
Expiration dating-
Tamper-evident packaging
Packaging and Labeling Control
Holding and Distribution • Written procedures
Holding – Distribution – Quarantined
Stored and shipped under appropriate conditions
Holding and Distribution
• FIFO
First In First Out
Laboratory Controls • Required for the establishment of, and conformance to written:
Specifications – Standards – Sampling plans – Test procedures – Other mechanisms
Records and Reports • Complete production, control, and distribution records – Maintained for not less than (Blank )after expiration date of the batch
1 year
Identified by lot number and product quality must be determined through appropriate testing
Returned and Salvaged Drug Products
are allowed if specifications are met
Salvaging or reprocessing
Complete records must be maintained
Returned and Salvaged Drug Products
