CGMP is Current Good Manufacturing Practice regulations enforced by the FDA and other regulatory authorities. CGMP standards provide for systems that assure the most updated and proper design, monitoring, and control of manufacturing processes (supply chain included) and facilities. The CGMP regulations reassure the identity, purity, quality of consistently manufactured goods by requiring that manufacturers adequately control operations.
This includes strong quality management systems, obtaining appropriate quality raw materials, establishing and specific operating procedures, detecting and investigating product quality deviations, and reliable testing laboratories. This formal system of controls at a GMP company, if adequately put into practice, helps to prevent instances of issues, problems, risks, contamination, mix-ups, failures, and errors assuring meeting quality standards.
The CGMP requirements have been established to be flexible (because this also is a management system standard) to allow each manufacturer to decide individually how to best implement the necessary controls by using scientific and technological design, processing methods, and testing procedures. The flexibility in these regulations adheres to companies to implement advanced technologies/ innovative approaches to achieve higher quality making continual improvement. Accordingly, the “C” in CGMP stands for “current,” requiring companies to use current(up-to-date)technologies and systems that comply with the regulations. Systems and equipment and machinery that may have been “up-to-date” to prevent contamination and errors 5 or 10 years ago maybe less than adequate by today’s standards.
Why CGMPs are important?
A consumer or the end-user usually cannot detect (through smell, touch, or sight) that a particular product is either safe or if it will work. While CGMPs require testing, testing alone is not enough to ensure quality. In most instances, testing is done on a sample of a batch (for example, a drug manufacturer may test 200 tablets from a batch that contains 2 million tablets). Therefore, products must be under conditions and practices required by the CGMP/FDA/WHO regulations wherever required to assure that quality. Technologically updated and modern facilities that are in good condition, equipment that is properly maintained, qualified, and calibrated, employees who are competent, qualified, and fully-trained, are a few criteria how CGMP requirements help in assuring the safety and purity of drug products.
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How does FDA regulate if a company acts under CGMP regulations?
FDA generally doesn’t inspect manufacturing facilities. Certification Bodies that have expertise in auditing, inspection GMP facilities worldwide, generally do that, including for facilities that manufacture active ingredients and the finished product. Inspections follow a standardized approach and are conducted by highly trained and qualified staff. Certification Bodies also relies upon reports of potentially defective drug products from the public and the industry. They also often use these reports to identify sites for which an inspection or investigation is needed.
Without CGMPs, are pharma/drug products/medical products safe for use?
For drug/pharma manufacturers, CGMP is mandatory. If a company is not complying with CGMP regulations, it is considered “adulterated” under the law of land. This kind of adulteration means that the drug was not manufactured under conditions with CGMP, prescribed by legal and regulatory bodies
If a consumer takes medicines violating the CGMPs regulations then FDA usually advises the consumers not to interrupt their drug therapy, which might have serious implications for their health. Consumers should then, seek advice from professionals before stopping or changing medications.
Regulatory actions against companies with poor CGMPs by the Government, are often intended to prevent the possibility of unsafe and/or ineffective drugs. In rare cases, FDA or the Government regulatory action is often intended to stop the distribution or manufacturing of the violated product. The impact of CGMP failure depends on the nature of those violations and the specific drugs involved. A drug manufactured in violation of CGMP may If the drug still meets its labeled specifications but a violation of CGMPs regulation then the drug is unsafe or ineffective could be minimal. Thus, FDA’s advice is more often very specific to the circumstances, and health care professionals are best able to balance risks and benefits (as relevant) and make the right decision for their patients.
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What can FDA or Government do to safeguard the public when there is a failure in CGMPs?
If the company fails to meet CGMPs results in the distribution of a drug, for example, it has a too less active ingredient, the company may subsequently recall back that product. Removing the drug from the market protects the public from any health issues. While FDA/GOVERNMENT/GOVERNMENT AGENCY-BODY/REGULATORY BODY cannot force a company to recall a drug, companies usually recall voluntarily or at FDA/GOVERNMENT/GOVERNMENT AGENCY-BODY/REGULATORY BODY’s request. If a company refuses to recall a drug, FDA/GOVERNMENT/GOVERNMENT AGENCY-BODY/REGULATORY BODY might warn the public and can seize the drug.
CGMP violations can be addressed or sued to court by FDA/GOVERNMENT/GOVERNMENT AGENCY-BODY/REGULATORY BODY even where there is no direct evidence of a defect affecting the drug’s performance. When FDA/GOVERNMENT/GOVERNMENT AGENCY-BODY/REGULATORY BODY brings a seizure case, the agency asks the court for an order that allows federal officials to take possession of “adulterated” drugs. When FDA/GOVERNMENT/GOVERNMENT AGENCY-BODY/REGULATORY BODY brings an injunction case, FDA/GOVERNMENT/GOVERNMENT AGENCY-BODY/REGULATORY BODY asks the court to order a company to stop violating CGMPs. Both seizure and injunction cases often lead to court orders that require companies to take many steps to correct CGMP violations, which may include repairing facilities and equipment, improving sanitation and cleanliness, performing additional testing to verify quality, and improving employee training. FDA/GOVERNMENT/GOVERNMENT AGENCY-BODY/REGULATORY BODY can also bring criminal cases because of CGMP violations, seeking fines and jail time.