A recent guide to clean room design for Good Manufacturing Practices (GMP) and Current Good Manufacturing Practices (CGMP).
Good Manufacturing Practices GMP
What is GMP?
Good Manufacturing Practices standardize production variables with minimum requirements for cleanliness, packaging, and ingredients for products that require licensing and authorization for market sale. Related industries include food and beverage, cosmetics, pharmaceuticals, dietary supplements, medical devices, and tobacco-related delivery systems. These recommended procedures and standards ensure that products maintain true-label ingredients and characteristics, such as identity, strength, composition, ingredient quality, and purity.
What is CGMP?
Current Good Manufacturing Practices (CGMP) apply specifically to pharmaceutical products. FDA inspectors verify that an entity has the necessary facilities, equipment, standards, and training for consistently delivering quality drugs to market.
- Application & Licensing: 21 CFR Part 314 and Part 600.
- Manufacturing Processing, Packing, or Storage: 21 CFR Part 210.
- Standards for Finished Products: 21 CFR Part 211.
For any product seeking market approval, GMP standards provide a technically sound approach to consistent and high-quality manufacturing processes.
Sterile Drug Products Produced by Aseptic Processing (CGMP)
Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice (CGMP) is a document guided by 5 regulatory bodies:
- U.S. Department of Health and Human Services
- Food and Drug Administration (FDA)
- Center for Drug Evaluation and Research (CDER)
- Center for Biologics Evaluation and Research (CBER)
- Office of Regulatory Affairs (ORA)
The document tackles specific guidances for aseptic processing of sterile drugs and biological products. The guidance document pertains to new or abbreviated drug applications (NDA or ANDA), or a biologic license application (BLA).
The document describes procedures and practices that enable sterile drug manufacturing to meet CGMP requirements. The scope includes facility design, equipment sustainability, process validation, and quality control.
Recommendations vs Suggestions
The guidance is not legally binding nor legally required for compliance. Guidance remains as a suggestion (should) or recommendations, not a requirement. Unless, specific statutory or regulatory requirements apply.
“This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations”
“The use of the word should in Agency guidance means that something is suggested or recommended, but not required.”
