GMP (Good Manufacturing Practice)

GMP (Good Manufacturing Practice) is a quality management system developed by the United States Food and Drug Administration (FDA) to ensure the quality of FDA regulated products like drugs (includes OTC), medical devices, food, etc.

The FDA sets forth guidelines to provide requirements that a manufacturer needs to meet to ensure that their products are consistently high in quality, from batch to batch, for their intended use. The main purpose is to prevent any harm from occurring to the end-user. Quality management systems for FDA regulated products like food, drugs, biologics and medical devices are generally known as current good manufacturing practices (cGMP).

The FDA sets standards through the Code of Federal Regulations (CFR) and carefully monitors the manufacturing practices including their methods, facilities, and controls used in manufacturing, processing, and packaging of drug products of these organizations. The FDA reviews these practices with their assessors and their inspectors determine whether the organization and their facility, equipment, and manufacturing processes comply with their regulations.

For example, facilities dealing with N95 Respirators and Surgical Face Mask must implement the medical device Quality Management System based on 21 CFR 820 and facilities dealing with Hand Sanitizers must implement a drug Quality Management system based on 21 CFR 211.

Implementation of GMP is significant in maintaining a competitive advantage for cannabis industry (Cannabis, CBD, and Hemp GMP).

21 CFR 820

21 CFR 820 is also known as medical device GMP (Good Manufacturing Practice).  These are the practices required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of devices.

These guidelines provide the minimum requirements that a manufacturer must meet to ensure that their products are consistently high quality for their intended use. The rules that govern each industry may differ significantly; however, the main purpose of GMP is always to prevent harm from occurring to the end-user. Additional tenets include ensuring the product is free from contamination, that it is consistent in its manufacture, that its manufacture has been well documented, that personnel are well trained, and the product has been checked for quality more than just at the end phase. Medical Device GMP standards are more or less the same as ISO 13485 in many ways.

21 CFR 211

21 CFR 211 is also known as the Drug GMP (Good Manufacturing Practice) for finished pharmaceuticals. Any US or foreign manufacturers or pharmaceutical companies dealing with the manufacturing, sales or distribution of pharmaceutical products in the USA are required to comply with 21 CFR Part 211. They must have implemented the GMP described in 21 CFR Part 211.

The Drug approval (NDA or ANDA) process includes a review of the manufacturer’s compliance with the cGMP. These regulations set forth the minimum requirements necessary to ensure safe and effective manufacturing practices. The FDA examines facilities around the world for compliance. Facilities that produce active ingredients and final products are also included in the inspection.

LMG New York can assist you with full implementation of a GMP Quality Management System:

• Quality Manual
• Quality System Procedures
• Internal Audit
• External Audit support
• GAP Analysis
• FDA Audit Support
• 21 CFR 211 Maintenance

QUICK LINKS