What is required in Section 211.80 General requirements?
Written procedures, preventing contamination during handling and storage, bags and boxes to be stored off the floor and suitable spaced, and a coding system
What is in section 211.82 Receipt and storage of untested components, drug product containers, and closures?
Visual examination for appropriate labelling, contamination and container damage
What is section 211.84 Testing and approval or rejection of components, drug product containers, and closures?
All will be withheld from use until the lot has been tested and released for use by QCU. Representative samples of each shipment shall be collected for testing.
What does it mean in section 211.86 Use of approved components, drug product containers, and closures?
First in first out, whereby oldest approved stock is used first
When does section 211.87 Retesting of approved components, drug product containers, and closures apply?
Retesting after storage for long periods, or exposure to heat and air.
What is section 211.89 Rejected components, drug product containers, and closures?
Rejected materials are identified and controlled under a quarantine system.
What is required of section 211.94 Drug product containers and closures?
Drug product containers and closures are not reactive, additive and absorptive. Cleaned to remove pyrogenic properties, and all procedures are written and followed.
Why is drug container and closure analysis important?
They can affect product shelf life, may be an additive, accelerate degradation reactions, and they protect contents from environmental conditions
What is required of section 211.100 Written procedures; deviations
Procedures reviewed by QCU, production records must be documented at time of activity, any deviations are recorded and justified
What is the purpose of written procedures?
To ensure drug manufacturing are the same standard and production is reproducible
What is the benchmark for a good written procedure?
An experienced person from another department can follow the procedure without doubts
Procedures are satisfactory if?
Working practice reflects written procedures, and they are easily accessible for reference
What should SOPs contain?
What are the procedures objectives, what is included, who to review and approve
What is the process and requirements to change or review SOPs
There is no direct impact to drug quality, and are only in effect after all outdated copies are replaced and staffed are retrained.
What is in section 211.101 Charge-in of Components?
The batch formulation should be 100% the quantity of each ingredient on the label.
What is in section 211.103 Calculation of yield?
Actual yields and theoretical yields shall be determined by 1 person, and verified by another.
What is in section 211.105 Equipment identification?
All compounding and storage containers, processing lines, and major equipment used are to be properly identified to indicate their contents and processing phase
What is in section 211.110 Sampling and testing of in-process materials and drug products?
Written control procedures for tests that are to be conducted. In-process materials shall be tested, rejected in-process materials are identified and controlled in a quarantine system .
What is required in section 211.111 Time limitations on production?
Time limits for each production phase are established, and any deviations are recorded and justified.
What is in section 211.113 Control of microbiological contamination?
Written procedures to prevent objectionable microorganisms in non sterile products and microbiological contamination of sterile products
What is section 211.115 Reprocessing?
It is a system that does not conform to standards or specifications, but requires approval of QCU
What is in section 211.122 Materials examination and usage criteria?
Written procedures for the labelling and packaging of materials,
products that meet specifications may be released, and products that do not will be rejected to prevent usage.
Records are to be kept.
Labels for each drug will be stored separately, and storage access will be limited to authorized personnel
Outdated labels are destroyed
Gang printing is prohibited
Printing devices are monitored
What is in section 211.125 Labeling issuance?
Labelling materials are carefully examined, quantities of labels are reconciled. Excess labelling should be destroyed, and returned labelling are stored to prevent mix ups and to provide identification
What are the rules for label use?
Writing is legible, old labels are removed, labels that come of must be replaced, and labels must be placed on body of container, never on lid
