Current Good Manufacturing Practices (cGMPs) are regulations called Code of Federal Regulations (CFRs) set by the United States Federal Drug Administration (US FDA). cGMPs are important to ensure that drug products made for human use meet the minimum quality requirements for the safety of patients.
What does it take to be considered a GMP Facility?
In order to be considered a Facility run in compliance with the GMP requirements, the facility must establish processes and procedures under the requirements in 21 CFR Part 210 and 211 (at a minimum) and other CFR parts are necessary dependent on the specific type(s) of business(es). In addition, the FDA may perform an inspection at a frequency of a "reasonable time" to ensure the GMP requirements are in place and are maintained in a satisfactory fashion.
The specific CFRs applicable to the GMP Facility with regard to Clinical Trials use with Human Cellular Products are:
cGMP or Current Good Manufacturing Practices refers to the FDA Code of Federal Regulations which provides minimum requirements for methods to be used in, and the facilities or controls to be used for, the manufacture, processing, packing, or holding of a drug meets the requirements of the act as to safety, and has the identity and strength and meets the quality and purity characteristics that it purports or is represented to possess.
• This purpose of this Part of the CFR lists the cGMP processes and systems necessary.
• Part 211 provides the basic minimum requirements by subpart as follows:
|A||General Provisions||Purpose, scope, definitions|
|B||Organization and Personnel||Responsibilities; functions of quality; training qualifications|
|C||Buildings and Facilities||Washroom facilities; sanitation; maintenance; design and construction; lighting; venting and air filtration; plumbing; sewage and refuse|
|D||Equipment||Equipment design size and location; construction; cleaning and maintenance|
|E||Components and Drug Product Containers and Closures||Receipt, storage testing and approval/rejection of materials; use of approved materials; retesting of approved materials; containers and closures|
|F||Production and Process||Written procedures; deviations; charge-in of components; yield calculation; equipment identification; sampling and testing of in-process materials and drug products; time limits on production; microbial contamination control; reprocessing|
|G||Packaging and Labeling||Material examination and usage criteria; labeling issuance; packaging and labeling operations; drug product inspection; expiration dating|
|H||Holding and Distribution||Warehousing procedures; distribution procedures|
|I||Laboratory||General requirements; testing and release for distribution; stability testing; special testing requirements; reserve samples; lab animals; penicillin contamination|
|J||Records and Reports||General requirements; equipment clean and use log; labeling records; master production and control records; batch production and control records; production record review; lab records; complaint files|
|K||Returned and Salvaged Drug Products||Returned drug products; drug product salvaging|
This purpose of this Part is to create a unified registration and listing system for establishments that manufacture human cells, tissues, and cellular and tissue-based products (HCT/P's) and to establish donor-eligibility, current good tissue practice, and other procedures to prevent the introduction, transmission, and spread of communicable diseases by HCT/P's).
In association with 21 CFR 211, for Cellular Products, Subpart D - Current Good Tissue Practice requires the following subparts in greater detail specific to Cellular Products:
Personnel; Procedures; Facilities; Environmental Control and Monitoring; Equipment; Supplies and Reagents; Recovery; Process Changes; Process Validation; Labeling Controls; Storage; Receipt, predistribution shipment, and distribution of an HCT/P; Records; Tracking; Complaint File.