What does following the cGMP regulations assure?
The identity, strength, quality and purity of drug products
When are the CFR Titles refreshed
Approximately 1st April every year
What does FPP mean?
Finished pharmaceutical product, it means a medicine presented in its finished dosage form that has undergone all stages of production including packaging in its final container labelling.
What is section 210.1 - Status of current good manufacturing practice regulations?
It covers the methods, facilities and controls used in the manufacturing, processing, packing or holding of drugs to assure that each drug are safe, and they meet the quality and purity characteristics that it purports.
What is section 210.2 - Applicability of current good manufacturing practice regulations
Different regulations for various drug types shall be considered to supplement, not supersede each other unless the regulations explicitly provide otherwise. If there are any conflicts, the regulation for the drug product in question shall supersede the more general.
What does section 210.3 - Definitions, batch refer to?
Batch refers to a specific quantity of a drug intended to have uniform character and quality, and is produced in a single manufacturing order during the same manufacturing cycle.
What does section 210.3 - Definitions, component refer to?
Component means any ingredient intended for use in the manufacture of a drug product including those that may not appear in such drug product.
What does section 210.3 - Definitions, drug product refer to?
Drug product means a finished dosage form such as tablets or solutions, that contains the active drug ingredient, generally in association with inactive ingredients.
What is section 211.1 - Subpart A, scope?
The regulations in this part contain the minimum cGMP for preparation of drug products for use in humans.
What is Subpart B - Organization and Personnel
It defines how the company must function, and the training personnel should perform their job.
What does Subpart B - Organization and Personnel consist of?
- QA and QC (Quality assurance, control)
- Appropriate qualification, education and training
- Personnel responsibilities - cleanliness, health, hygiene, PPE
What is the role of a QA and QC.
- Their role is to set standards and to physically control drug quality .
- They have the responsibility and authority to approve and reject all drug components, product containers, packaging materials, or any procedures and specifications impacting on the safety, identity, strength, quality and purity of the drug product.
- Authority to review production records, and they consist of qualified pharmacists, microbiologists and chemists.
What are the responsibilities of quality assurance (QA)?
To review and approve all systems and procedures, oversee total quality and products, and to set standards used in manufacturing processes.
What are the responsibilities of QC?
To perform inspection and testing for drug components. Also to sample, test and verify every activity associated with sampling and testing. Lastly, to check the quality and condition of equipment and monitor the environment for each process.
All these should be documented
What are examples of section 211.25 - Personnel Qualifications
They should have education, experience, and training in the particular operation and GMP.
What are examples of section 211.28 - Personnel responsibilities
Cleanliness, personal hygiene, PPE, health conditions
What is subpart 211.34 - Consultants
Consultants shall have enough education, training and experience to advice on the subject. Any services they provided should be recorded
What are the features of Section 211.42 - Design and construction features: Environment
Environment is up to standard, appropriate plant design, correct temperature and humidity for both comfort and function
What are the features of Section 211.42 - Design & Construction Features: Construction Materials
Walls and floors durable with epoxy paint and flooring. No holes and cracks to prevent dirt accumulation. Ceilings are smooth with seamless plaster and non brittle. Easy maintenance access for water etc.
What are the features of Section 211.42 - Design & Construction Features: Aseptic processing
Environmental control through HEPA air filters (0.3nm particles at 99.97%)
What are 3 examples of precautions in preventing contamination and mixups?
Separate holding areas for rejected materials, packaging and labelling, quarantine storage before release
What is required in section 211.46 Ventilation, Air Filtration, Air Heating and Cooling
Sufficient ventilation. Equipment for controlling parameters such as pressure, humidity, temperature
What is required in section 211.48 - Plumbing
Potable water supplied under positive pressure to prevent contamination. Drains are big enough and have air breaks to prevent backflow
What is in section 211.50 Sewage & Refuse
All waste is to be disposed in safe and sanitary matter
