Understanding 21 CFR Part 211

What is 21 CFR Part 211?

The Code of Federal Regulations Title 21 Part 211 (21 CFR Part 211) refers to the current Good Manufacturing Practices (cGMPs) set by the FDA for finished pharmaceuticals. These requirements are meant to ensure that finished drug product is handled in a way that does not affect its efficacy or cause harm to the end user and bring modern quality assurance and control principles to drug manufacturing.

Requirements for FDA 21 CFR Part 211

Requirements include:

  • A quality control system to approve or reject drug products
  • Adherence to written procedures for production and process control
  • Detailed records and reports written and maintained throughout processing of all batches
  • Quality controlled records and signatures for all documentation
  • Proper equipment in-house for drug handling, packaging, and labeling compliant with federal standards
  • A quality system in place to ensure correct function and calibration of all equipment
  • Adequate ventilation and sanitation throughout all storage and processing facilities
  • Appropriate training, education, and experience for all personnel engaged in drug product manufacturing, processing, and packaging
  • Ability to examine and test components, drug product containers, and closures
  • Ability to properly distribute finished packaged products
  • Ability to properly destroy and dispose of any corrupted drug product

21 CFR Part 211 Compliance

In order to become 21 CFR Part 211 compliant, a manufacturer must demonstrate that their facility, employees, and equipment are in line with the requirements listed previously. Along with these requirements, the manufacturer must have a plan and quality team in place to ensure that these standards are maintained for the foreseeable future, or as long as the manufacturer wishes to remain compliant. By following these regulations, a medical device manufacturer will be able to handle finished drug products within their facility for services such as kitting and packaging.

Does Gilero Follow 21 CFR Part 211?

Gilero expects to become compliant to applicable parts of 21 CFR Part 211 that pertain to combination device development and manufacturing by October 2021. Our manufacturing facility in Pittsboro, NC abides by current Good Manufacturing Practices and has been working to better serve our pharmaceutical customers through expanded drug handling capabilities. The ability to handle finished drug products will broaden Gilero’s drug kitting and packaging services for drug delivery and combination product devices.

Gilero Pittsboro is a 40,000 square foot manufacturing facility with over 9,000 square feet of cleanroom space. This location provides assembly, kitting, and packaging services for medical devices, drug delivery systems, and combination products. To learn more about Gilero’s manufacturing capabilities, contact us today!

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