21 CFR Part 211

21 CFR is the FDA regulation for finished drugs and medications. It is considered the current Good Manufacturing Practice for these medications by the FDA. It is one of the most important regulations set up by the FDA as it contains specific regulatory requirements regarding drug manufacturing facilities, equipment, production, packaging, storage, etc.

What is 21 CFR Part 211 in simple words?

21 CFR part 211 is a section of the Code of Federal Regulations (CFR), a document containing the code of all regulations (permanent and others) imposed by the Federal Register and the Federal Government.

The CFR is an extensive collection of regulations covering different sectors. Title 21 of CFR applies to food and drugs, with subchapter C dedicated to medications in general. Subchapter C of title 21 of CFR contains part 211, titled “Current Good Manufacturing Practice for Finished Pharmaceuticals.” This part regulates the expected minimum standards for drug manufacturing and marketing in the USA.

21 CFR Part 211 outlines the FDA-enforced regulatory requirements for drug manufacturing in the USA and provides details for each requirement. The regulation applies to all drugs for administration to humans and animals and is one of the most important regulations for pharmaceutical manufacturers.

Get a clear breakdown of complex GMP requirements for the pharmaceutical and life sciences industries.

What is the importance of 21 CFR Part 211?

21 CFR part 211 is the gold standard for drug manufacturing in the USA. The FDA expects manufacturers to adhere to these guidelines and will assess an organization’s manufactured pharmaceutical products. Following at least the minimum requirements set in this regulation is also considered a standard practice to ensure the production of safe, effective, and strong drugs.

What are the requirements of 21 CFR Part 211?

21 CFR part 211 is divided into eleven subparts. Each subpart provides regulatory requirements for manufacturers to ensure the production of safe, effective, and high-quality drugs.

General provisions

This subpart outlines the scope and definitions relevant to the regulations. The regulation applies to all drugs (except PET drugs), including both human and animal medications. However, if there is a more specific regulation for a drug, the more specific regulation will apply.

Organization and personnel

This part of 21 CFR part 211 provides detailed requirements regarding quality control, staff qualification, consultancy, etc. It requires having a quality control unit with access to the drug manufacturing process, packaging, and storage, and adequate laboratory access for testing. This subpart also emphasizes having adequately trained personnel, preventing contamination from staff, and hiring qualified consultants.

Buildings and facilities

21 CFR part 211 discusses detailed requirements for facility designs, including construction, ventilation, air cooling, plumbing, sanitation, and other related areas. The regulations require pharmaceutical manufacturers to perform proper maintenance.

Equipment

All equipment must have the correct design and size and be stored correctly according to the regulations. If equipment is constructed on-site, it should be appropriately designed so as not to affect the safety, efficacy, or quality of the drugs. Proper maintenance of all equipment is crucial for safe pharmaceutical production.

Control of components and drug product containers and closures

To prevent contamination and mislabeling, all drug components and product containers must be inspected, labeled, and stored concisely with detailed receipts. The regulations also require component testing. Manufacturers are expected to regularly test samples of each drug component lot and approve or reject them based on the results. Until cleared, the components must be quarantined to prevent contamination. Moreover, the FDA requires manufacturers to maintain sterility and follow specific sampling, storing, and closure methods.

Production and process controls

The FDA and most regulatory organizations require thorough documentation. All production procedures and process controls should be in written format. The written process should be verified and any changes documented. The written document should include necessary details like the weight of the components, calculation of yield, all equipment used, time limitation, important parameters, and packaging instructions.

Packaging and labeling control

Proper packaging might affect drug safety and efficacy. 21 CFR part 211 requires written procedures and records to ensure correct labeling control, material examination, and prevention of mislabeling and cross-contaminations.

Holding and distribution

All warehousing and distribution procedures must be done according to written procedures and with proper supervision.

Laboratory controls

All laboratory controls (for example, standards, tests, and sample collection processes) should be in written format and approved by the quality control unit. Proper testing before release for distribution should be maintained. The FDA also requires frequent stability testing, sample testing, and contamination prevention.

Records and reports

As per this regulation, any drug production, control, or distribution should be recorded along with drug components, containers, batch info, storing details, distribution details, complaints, etc. All associated processes, such as equipment cleaning and use, should also be logged. Lab results that show compliance should also be documented.

Returned and salvaged drug products

The FDA provides specific instructions on whether and how to store or dispose of returned drug products and drug product salvaging.

This sums up 21 CFR part 211. You can get the specifics of the regulations here.