INTRODUCING: Current Good Manufacturing Practice (cGMP) Training with TLC Regulatory and Laboratory Consulting.
Special Topic Camps:
Structured into manageable, effective ½-day camp courses that build on each other, are designed for different levels of cGMP experience, and cover a variety of cGMP topics.
Current Good Manufacturing Practices (cGMPs) are the regulations that are issued and enforced by the United States (U.S.) Food and Drug Administration (FDA) to control and supervise companies that manufacture, package, hold, and distribute foods, drugs, and cosmetics to the public. The FDA has promulgated cGMPs for Food, Dietary Supplements, Pharmaceutical Drugs, Medical Devices, Blood for Transfusion, Animal Foods and Feed, and Veterinary Medicines; and has proposed cGMPs for Cosmetics and Tobacco. All of these cGMPs have common requirements that apply to personnel, facility, equipment, process controls, and overall operations for manufacturing, packaging, labeling, storage, and distribution. This training CAMP provides an overview of the issuance, enforcement, and basic principles of cGMPs.
Dietary Supplement cGMPs
Current Good Manufacturing Practices (cGMPs) specific for dietary supplements are dictated in 21 CFR 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. This training CAMP builds on the Basic cGMPs camp by providing specific information on the 21 CFR 111 requirements for the establishment of specifications, determining whether those specifications are met via testing, ensuring that a Master Manufacturing Record (MMR) is created for each product and each batch size, a Batch Production Record (BPR) is prepared for every manufactured and packaged dietary supplement product, and that Quality Unit (QU) personnel are assigned to develop and implement a Quality Management System (QMS) and oversee all operations.
All pharmaceutical drugs must be approved by the FDA through a New Drug Application (NDA), Abbreviated New Drug Application (ANDA), or Over the Counter (OTC) Drug Review (OTC monograph) process for a nonprescription drug to ensure that the drug is safe and effective in its proposed use(s), and the benefits of the drug use(s) outweigh the risks. Regardless of the approval process, the Current Good Manufacturing Practices (cGMPs) that apply are 21 CFR 210, Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General, and 21 CFR 211, Current Good Manufacturing Practice for Finished Pharmaceuticals. These cGMPs dictate strict requirements for control of the entire manufacturing and packaging process, and testing of raw materials, in-process materials, and finished drug products. Quality Unit (QU) personnel are also essential to develop and implement a Quality Management System (QMS) and oversee all operations. This training CAMP elaborates on the Basic cGMPs and provides details on the requirements for compliance with the drug cGMPs in 21 CFR 210/211.
cGMPs for Cannabis
The Agriculture Improvement Act of 2018, referred to as the Farm Bill, defined “hemp” as a category of Cannabis sativa with a (delta-9) tetrahydrocannabinol (THC) content of not more than 0.3% on a dry weight basis. The Farm Bill also removed hemp from the Controlled Substances Act, but it did not change the fact that the FDA has authority over food and dietary supplement products that hemp may be added to; and that doing so is currently illegal. Notwithstanding the FDA’s position, cannabis products are cultivated, processed, and intent of these requirements is to ensure that products are consistently manufactured to meet pre-assigned quality standards. The best way to ensure that this is the case is to establish a Current Good Manufacturing Practice (cGMP) Quality Management System (QMS). This can be challenging given the nature of the Cannabis sativa raw material and strict requirements for THC of the finished cannabis product, but the application of the Basic cGMPs and broad use of other cGMPs is an excellent approach that will be discussed in this training CAMP.
Laboratory operations, whether internal at a manufacturing facility or external at a contract laboratory, are an essential part of Current Good Manufacturing Practice (cGMP) requirements. All Quality Unit (QU) disposition decisions to accept or reject materials and products are made based on results generated by the laboratory. Laboratory facilities, equipment, operational procedures and processes, and test methods must therefore, be appropriate for their intended use and conducted in compliance with cGMPs; and laboratory personnel must be qualified to perform their assigned job functions. Written procedures must also be in place for all laboratory operations, including for valid test methods, and documentation of the performance and results of each test method must be provided contemporaneously. This training CAMP will cover the overall Quality Management System (QMS) that is required in the unique, laboratory environment.
TLC Regulatory and Laboratory Consulting is happy to be part of the regulatory educational training program for clients.