GMP refers to the Good Manufacturing Practice
Regulations published by the FDA under the Federal Food, Drug, and Cosmetic
Act. As a response to concerns about substandard drug manufacturing practices occurring
at the time, Congress enacted the 1962 Drug Amendments. These amendments
instructed the FDA to require all drugs to be made according to Good
Manufacturing Practice (GMP) as defined under FDA 21 CFR Part 210-211.
The first set of Good Manufacturing Practices (GMP) or
custom manufacturing regulations
were published in 1963. These regulations are meant to guide companies in the
production of safe and effective drugs. The regulations outlined in the GMPs
are the minimum requirements necessary to ensure safe and effective products.
In this blog, we'll discuss the definition of GMP,
various regulatory components, and why it's important for companies in the life
sciences space.
Trained inspectors for the FDA examine facilities
around the world, including those facilities that produce the active
ingredients and final products. The FDA also reviews consumer and industry
complaints filed about the drug, using these reports to identify sites that
could benefit from the inspection.
About GMP
GMP is a set of regulations that ensures the quality
of drugs, medical devices, blood, and some types of food. The regulations cover
manufacturing, facilities, and controls for the manufacturing, processing,
packaging, or holding of a drug product.
When discussing current good manufacturing practices,
many agencies use the acronym cGMP, with the letter ‘c’ standing for ‘current.’
This nomenclature reminds companies to use the most up-to-date technologies and
systems in order to comply with current regulations. Many older GMP practices,
specifically those designed to prevent errors, mix-ups, and contamination, are
now outdated and inadequate.
About Part
210 and 211
21 CFR Part 210 and 211 outline the manufacture,
processing, packing, or holding of a drug specifically, although supporting
companies and services can benefit from compliance with these standards as well.
Part 210.2 applies to drug products intended for human
use and lays out definitions for terms used within the document. Part 211
describes important issues.
Its 11 subparts discuss all sections of drug
manufacturing operations:
1.
General Provision
2.
Organization and Personnel
3.
Building and Facilities
4.
Equipment
5.
Control of Components and Drug
Product Containers and Closures
6.
Production and Process Controls
7.
Packaging and Labelling Controls
8.
Holding and Distribution
9.
Laboratory Controls
10. Records and Reports
11. Returned and Salvaged Drug Product
Each section of code outlines a different GMP
activity. 211.22 details the responsibilities of a quality control unit, for
example, while 211.25 discusses personnel qualifications, 211.28 deals with
sanitation, clothing, protective apparel, hygiene and health habits and 211.34
offers guidelines on working with consultants. Part 1271 subparts C and D
describes donor-eligibility and applicable current good tissue practice
procedures for owners and operators of establishments engaged in the recovery,
donor screening, donor testing and other types of testing, processing, storage,
labeling, packaging, or distribution of human cells, tissue samples, and
cellular and tissue-based products (HCT/Ps).
What GMP
Means for Companies in the Life Sciences Space
GMP regulations address a wide range of production
activities, including starting materials, sanitation, and cleanliness of the
premises, equipment verification, and process validation. GMP regulations even
extend into human resources and general offices, offering practice guidelines
for record-keeping, personnel qualifications, complaints, training, and
personal hygiene of staff working in regulated areas. GMP requires documented
proof of consistent adherence to established procedures at every step in the
production process.
While stringent in their requirement for quality, most
GMP regulations are open-ended and flexible in that they allow individual
companies the latitude to decide on the best way to implement the controls
necessary to achieve the highest quality within each organization. Failure to
comply with these regulations may result in regulatory action for the drug and
for the company responsible for the failure.
Virtually every person in the United States is
affected by the quality of pharmaceuticals. Nearly 70 percent of Americans take
a prescription drug, according to Mayo Clinic, and almost half take two. The
use of non-prescription or over-the-counter (OTC) drugs and supplements is also
widespread. cGMPs are important because consumers cannot
easily detect an unsafe or ineffective product simply by looking, smelling, or
touching it. GMP testing, typically performed on small samples from a batch,
ensures that the rest of the batch provides the high-quality medication or
supplementation desired by these consumers.
Your work holds the potential to deliver life-changing
treatments. Our mission is to help you succeed. Ensure the integrity of your
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