What is cGMP?
Good Manufacturing Practices (GMPs) are regulations that apply to the methods, equipment, facilities, and controls required for manufacturing various products, including foods, pharmaceutical products, veterinary products, and medical devices. Most GMPs vary by country. In the United States, GMPs relating to pharmaceutical forumlation is referred to as Current Good Manufacturing Practices (cGMP). United States’ cGMP regulations are promulgated by the United States Food and Drug Administration (FDA). Title 21 of the Code of Federal Regulations is dedicated to the rules of the FDA. The regulations set forth in Part 210 as well as Parts 211 through 226 of Chapter I, Title 21 “contain the minimum current good manufacturing practice for methods to be used in, and the facilities or controls to be used for, the manufacture, processing, packing, or holding of a drug to assure that such drug meets the requirements of the act as to safety, and has the identity and strength and meets the quality and purity characteristics that it purports or is represented to possess.” (21 CFR 210.1(a)).
FDA cGMP regulations are mandatory. All drug related products, whether prescription or over-the-counter, which are intended for commercial use in the United States must be produced according to the FDA’s cGMP regulations. “The failure to comply with any regulation set forth in this part and in parts 211 through 226 of this chapter in the manufacture, processing, packing, or holding of a drug shall render such drug to be adulterated [meaning contaminated] . . . and such drug, as well as the person who is responsible for the failure to comply, shall be subject to regulatory action.” (21 CFR 210.1(b)). The regulatory action can range from the recall or seizure of the non-compliant products to fines and even jail time.
New drug development that is carried out according to cGMP regulations is considered safe, effective, properly identified, of the appropriate strength or potency, pure, and of high quality. cGMP regulations require not only manufacturers, but also processors and packagers, of a variety of pharmaceuticals to take proactive steps to ensure adherence to cGMP regulations. Manufacturers, processors, and packagers must take a top-quality approach in performing their responsibilities in order to minimize, and more importantly, eliminate instances of contamination and errors. In turn, the company as well as the consumer is protected. The company can be protected from legal action. The consumer is protected from purchasing or using a product that may be hazardous or ineffective.
What Falls Under cGMP Regulations?
cGMP regulations identify a variety of responsibilities for manufacturers, processors, and packagers of pharmaceuticals to follow. For example, cGMPs necessitate specific documentation and other recordkeeping, quality control unit responsibilities, personnel qualifications and responsibilities, design and construction standards, sanitation and cleanliness standards, equipment verification, process validation, and standards for complaint handling, equipment, and product testing. It is argued that the documentation requirements are an extremely important aspect of cGMP. Manufacturers, processors, and packagers must detail every aspect of the process, activities, and operations they utilize during their individual pharmaceutical related tasks. If the documentation showing how a product was made and tested is not correct, the product will not meet the required cGMP manufacturing specification. Consequently, the product will be considered contaminated or adulterated and cannot be distributed within the United States.
Many cGMP requirements are considered general or vague, which allows each company the flexibility to decide how to implement the necessary controls in that specific company. cGMP rules also regulate the training necessary to perform duties relating to the manufacture, processing, and packaging of pharmaceuticals. The cGMP requirements for dosage form development in the United States requires individuals to be explicitly educated, trained, and experienced, or any combination thereof, to enable that person to perform the assigned functions. Training must be related to the particular operations the individual will perform. Additionally, each individual must be trained in cGMP policies and regulations on a continuing basis to assure they remain familiar with cGMP manufacturing rules and requirements.
IriSys cGMP Formulation Services
IriSys’ formulation development scientists and manufacturing
unit work together to optimize the formulation and scale-up for
the cGMP manufacturing of clinical trial materials for Phase I
and Phase II trials. IriSys cGMP manufacturing team is under
the jurisdiction of the Quality Assurance Unit and complies with
IriSys’ Standard Operating Procedures and FDA Guidelines. IriSys
provides the following cGMP manufacturing services.
- Scale up from R&D to cGMP manufacturing
- Technology transfer
- Drug Development Process
- Formulation optimization for manufacturing of drug product
- Clinical trial materials manufacturing for Phase I and Phase
- Release testing
- Certificates of Analysis
- Formal stability studies according to ICH guidelines
IriSys has the capability to manufacture the following dosage
forms for Phase I and Phase II clinical trials.
- Capsules, hard gelatin or HPMC liquid-filled
- Capsules, hard gelatin or HPMC, powder-filled
- Capsules, controlled or sustained release
- Tablets, immediate release
- Tablets, controlled or sustained release
- Tablets, enteric coated
- Topical gels, creams, ointments
- Oral liquids
- Over encapsulation