March 1, 2023
The current Good Manufacturing Practice (cGMP) regulations - originated and checked by the FDA - apply to companies operating in pharmaceutical, biotech, or med tech industries.
They require the latest standards in terms of production, manufacturing, and packaging and thereby ensure pharmaceutical quality meaning quality in biopharmaceutical processing and patient safety as the ultimate goal. The detailed guidelines, importance of cGMP, and how companies can best meet the cGMP regulations, are discussed in the following.
Current Good Manufacturing Practice, also known as cGMP, are a set of regulations that ensure the quality of pharmaceutical products, medical devices, biotechnology products, food and beverage, and dietary supplements. They therefore apply to all organizations involved in the manufacturing processes of these products.
To be compliant with the cGMP regulations, companies must meet the latest quality standards. These apply to buildings and facilities, equipment, production, process controls, laboratory controls, packaging and labeling, and returned or salvaged drug products.1
cGMP compliance is monitored by the Food and Drug Administration (FDA). It sets the rules of CFR (Code of Federal Regulation) Title 21 based on the Federal Food, Drug and Cosmetic Act. The parts addressing the cGMP, list the minimum requirements of the production process from start to finish in order to ensure that the drug product has the identity, quality, strength and purity promised.2
The cGMP guidelines are described in several parts of Title 21 and allow a good understanding of the regulatory process:
21 CFR Part 314: Applications for FDA Approval to Market a New Drug
21 CFR Part 210: cGMP for Manufacturing, Processing, Packing, or Holding of Drugs
21 CFR Part 211: cGMP for Finished Pharmaceuticals
21 CFR Part 212: cGMP for Positron Emission Tomography Drugs
21 CFR Part 600: Biological Products: General
The following three paragraphs will outline 21 CFR Part 210 in which most regulations revolve around requirements for staff, equipment, facilities, and the production process.
Especially for companies and organizations involved in drug manufacturing and therefore representing a key cGMP requirement, qualified and trained staff is crucial. The personnel must be appropriately qualified and trained and keep up-to-date with the latest training and knowledge relevant to their tasks.
To be compliant with cGMP regulations, pharmaceutical companies’ buildings and production facilities must be properly and thoroughly maintained to ensure safe and effective manufacturing conditions. Similarly, current Good Manufacturing Practices require organizations to have modern equipment that is conscientiously maintained and not outdated at any time. The same applies to the Standard Operating Procedures (SOP).
cGMP recommend that the processes used to manufacture pharmaceutical products involve the latest science and technology. In addition, it is crucial that a master formula is adhered to for each product throughout the manufacturing process without any deviations.
Like the cGMP, Good Manufacturing Practice (GMP) is part of quality assurance and ensures that companies involved in manufacturing, processing, and packaging drugs, medical devices, some sorts of food, and blood follow certain quality and effectiveness standards. Thereby they should eliminate or at least minimize any kind of contamination, mix-ups, or errors guaranteeing that customers purchase effective and safe products. They concern issues such as equipment verification, process validation, record keeping, and process improvements in form of standardization.
GMP guidelines are very general in nature, meaning that the manufacturers decide and interpret themselves how to best implement them in their business. However, they do have the force of law and can in some cases result in fines, recall, seizure, and jail time if failed to comply.
Since those regulations frequently change, the so-called current Good Manufacturing Practice (cGMP) is a more recent version of the GMP requiring companies to use technologies and systems that are up-to-date.3
Seemingly no difference, the timeliness of the regulations results in differences between GMP and cGMP in terms of quality, cost, and standards:
EU GMP Annex 1 is a regulatory guideline that sets standards for manufacturing sterile medicinal products. The guidelines are set by the European Medicines Agency (EMA) and FDA. It focuses on aseptic processing and contamination control to ensure product safety and quality. The annex covers various areas such as facility design, environmental monitoring, personnel training, and process validation. One significant aspect influenced by Annex 1 is the use of single-use assemblies in fluid management processes. It emphasizes the need for a risk-based approach to ensure the integrity and sterility of single-use systems used in closed systems for fluid management. Compliance with GMP Annex 1 is crucial for companies operating in the biopharmaceutical industry to meet regulatory requirements and maintain high-quality standards.
The FDA’s role is to first promulgate cGMP regulations and guidance documents and then to determine whether the quality of pharmaceutical products comply with those regulations. In doing so, trained FDA assessors and investigators inspect companies around the world to verify that the facilities, where active ingredients and finished pharmaceutical products are manufactured, meet the standards. Inspections follow a standard procedure and are often based on reports or concerns flagged by the public and the industry. If cGMP violations are found, the manufacturer should implement corrective and preventive actions as part of the overall quality management system.
Compliance with cGMP requirements assures end-users that products were manufactured in accordance with the most recent industry standards and are therefore pure, safe, and effective. It ensures:
In order to fulfill the cGMP guidelines, pharmaceutical companies are heavily dependent on equipment suppliers.
Companies that want to fill, freeze, and ship in a cGMP compliant manner, typically face several challenges. There is still a severe technology gap in the biopharmaceutical production that hinders manufacturers from standardizing and scaling the process. Single-use technologies in biopharmaceutical processing ensure greater safety, maintain drug substance quality, and are highly efficient and scalable. Fully automated single-use filling platforms like RoSS.FILL from Single Use Support enable standardization, which is crucial for meeting cGMP requirements.
Looking for real-time information about an active ingredient? Single Use Support’s Ultra Smart Tracking helps verify temperature, geo-position, air pressure and much more 24/7 during international shippings in adherence with 21 CFR Part 11.
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