Discover what U.S. federal mandates apply for finished pharmaceuticals sold in the U.S. and how digitisation makes compliance easier.
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European pharmaceutical manufacturers that market products in the U.S. are required to comply 21 CFR 210 and Part 211, regulations which outline production practices and controls for finished pharmaceuticals.
Part 210 outlines CGMP to maintain drug integrity. Part 211 outlines controls for finished pharmaceuticals sold in the U.S. Together they provide a framework to safely distribute drugs in the U.S.
U.S. Food and Drug Administration (FDA) inspections ensure that pharma companies who wish to sell products in the U.S. are compliant with regulations. Manufacturers are required to give regulators access.
Non-compliance with regulations can lead to regulatory actions and sanctions by the U.S. Food and Drug Administration (FDA). Companies risk being prevented from legally marketing products in the U.S.
European pharmaceutical manufacturers must achieve 21 CFR compliance in order to market their products. Major points of 21 CFR parts 210 and 211 are listed below.
All responsibilities and procedures relating to any pharmaceutical manufacturing practice and quality control must be in writing and followed. Reports must be made available to inspectors.
Manufacturers’ facilities must be a suitable size, cleaned, maintained, and facilitate orderly operations. Environmental conditions must serve to preserve drug integrity and prevent contamination.
Equipment design, size, and location must be suitable for intended use and uniquely identified. Equipment must be regularly cleaned, sanitised, maintained, and calibrated as necessary.
Manufacturers must handle raw materials, components, and closures properly to ensure drug quality and prevent contamination and mix-ups.
In-process controls, tests, and/or examinations must be conducted on appropriate samples to assure batch uniformity and integrity of drug products.
Prior to distribution, products must clearly identified and traceable. Complaints must be registered and responded to. Quality reviews must be conducted at least annually.
Get clear on the FDA’s definitions, current good manufacturing practices, and related regulations for finished pharmaceuticals.
Learn about 21 CFR Parts 210 and 211Digitisation plays a significant role in helping companies adhere to 21 CFR part 210 and 211 guidelines for pharmaceuticals. It also enables manufacturers to modernise their operations, improve efficiency, manage change control, and produce consistently higher-quality products.
Digital systems provide robust audit trail capabilities, ensuring the integrity and traceability of data.
Automated workflows can ensure that changes follow proper approval routes and are implemented consistently, reducing the risk of non-compliance.
Training materials can be stored, tracked, and assigned based on roles. Automated reminders ensure that personnel stay up -to -date with required training.
Companies can electronically record and track any quality event, including deviations and non-conformances, as well as automate and route corrective action/preventive action (CAPA) processes.
Digitised systems must be validated to ensure they perform as intended and meet regulatory requirements. Reputable software vendors can offer validation tools for use with their products to streamline validation and facilitate more frequent upgrades.
Use electronic batch records to automate core processes, document management activities, promote collaboration, improve decision making, and accelerate time to market.
Compliant pharmaceutical manufacturing must take place in a controlled environment. Find out how quality management software makes this possible.
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