Medical Device manufacturing has to comply with FDA guidelines and regulations for tracking each and every step of the manufacturing process, including raw material sourcing. These guidelines are known as current good manufacturing practices (cGMP) and each facility that is FDA certified is also regularly inspected. The cGMP regulations are published in the Federal Register in 21 CFR Part 820 for Medical Devices.
The FDA enforces cGMP regulations by monitoring the facilities, equipment, employees, and processes of manufacturers. This includes ensuring that facilities are in good condition, that equipment is properly maintained and calibrated, that employees are qualified and fully trained, and that processes are reliable and reproducible. By doing this, the FDA assures that manufacturing processes meet these basic requirements:
Compliance with manufacturing regulations and certain standards is a critical part of advancing a safe and effective product through approval to market. cGMP are defined as “a set of current, scientifically sound methods, practices, or principles that are implemented and documented during product development and production to ensure consistent manufacture of safe, pure, and potent products.” The cGMP regulations apply to both manufacturing processes and facilities, and require complete process documentation.
Documentation is key to GMP compliance and ensures traceability of all development, manufacturing, and testing activities. To be able to track all documentation, there must be revision control when a document is updated; including a signature and date of the appropriate reviewers. Adequate documentation also provides auditors with what they need to fully assess the overall quality and performance of operations within a company.
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Different GMP levels are observed throughout the manufacturing areas at Boyd Biomedical and are defined by environmental cleanliness levels; with the ISO Class 7 cleanroom being the cleanest. The cleanliness is reflected in the processes and knowledge from operators to executive management. Additionally, there are written procedures for cleaning manufacturing areas and equipment. Changes to sanitation practices should be communicated throughout an organization and are critical to maintaining a clean and sustainable facility that is well-maintained and approachable.
Validation may apply to a specific product, equipment, or process. All processes where the output cannot be fully verified by subsequent monitoring or measuring should be validated, and there should be complete documentation surrounding the validation activities. Equipment should be monitored for calibration regularly and should be revalidated if results aren’t consistently meeting defined requirements. Validation is important to help determine what process controls are required to meet the defined requirements and assure conformance to specifications.
The raw material manufacturers should be continuously evaluated based on given supplier requirements. The team should review and determine the purchase requirements and standardize them for all suppliers. The performance of the raw material supplier must be monitored for ongoing consistency.
SOPs maintain cGMP documentation, which are written guidelines that explain each step of the production process. The purpose is to ensure that employees complete every step of an operation in a consistent manner, in a controlled environment, and with quality standards guiding their intended use. SOPS and records are critical to the product development process. SOPs should also include departmental responsibilities, for example; the quality assurance department maintains documents and record keeping, which includes training records and other related documentation.
Manufacturers can meet the cGMP regulations of the FDA by ensuring that manufacturing processes, equipment, personnel, and facilities are in good working order and remain in compliance with cGMP regulations. It is important to note that continual evaluation of these processes is critical to maintaining compliance with the FDA and remaining aligned with your current business and manufacturing practices.