Things You Need To Know About cGMP

CGMP or Current Good Manufacturing Practice regulations are enforced by the US Food and Drug Administration (FDA). They provide for systems which can assure proper monitoring, design and control of manufacturing processes and facilities. By adhering to CGMP regulations, you can assure the quality, strength and purity of any product manufactured by a company. You can reduce instances of errors, contamination, failures and deviations by having a system of regulations and controls in place. CGMPs are flexible enough to allow different manufacturers to individually and independently decide on how to implement the regulations and controls required by their organization.

Importance of CGMPs

It isn’t possible to detect whether a product is safe, of low quality or if it’ll function the way it is intended to just by sight, touch or smell. Without CGMPs, determining the quality of any product would get tricky. When products are manufacturers complying with CGMPs, the quality and safety of those products can be assured.

Determining if a company is complying with CGMP regulations

FDA carries out inspections in various companies worldwide, including all those units that produce active ingredients and the finished product. These inspections are extremely thorough and are carried out by highly trained FDA staff. They create corresponding reports and also take the help of reports pertaining to potentially defective drug products from the public and the industry. FDA will determine which companies need an inspection and recognize all those that are fully compliant with the CGMP regulations.

Is it safe to use products manufactured by those not following CGMPs?

Products manufactured by companies that aren’t complying with CGMP regulations are considered ‘adulterated’ under the law. This means that the product wasn’t manufactured using the required regulations, but that doesn’t necessarily mean that the product is entirely unsafe to use. A drug can be manufactured with violation of CGMP but it may still meet the labeled specifications, thus reducing the risks of it being unsafe. However, it is advised to use only those products manufactured by companies complying with CGMP. Consult with your doctor and health care professionals before using any new drugs.

How Does FDA protect the public in case of CGMP Violations?

If a company produces a drug that doesn’t comply with CGMP, they may have to recall that product on the request of FDA to protect the public. Though FDA cannot force a company to recall products, they can warn the public and seize the products. However in most cases, companies oblige and carry out recall operations. FDA can also bring injunction or seizure cases in the court if they find a company violating CGMP regulations. They can also bring criminal cases because of CGMP violations, and may seek fines and jail time.

Where can you learn about CGMPs as a new company?

A new company may log onto the FDA’s website (www.fda.gov) which contains links referring to the latest CGMP regulations and guidance documentations. They also publish the same in the Federal Registry. You can also find various resources that will help drug companies comply with the law. Apart from these, you can also take advantage of the public outreach programs and presentations conducted by FDA at national and international meetings and conferences where CGMP requirements and the latest policy document are discussed.

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