Understanding 21 CFR Part 211
What is 21 CFR Part 211?
The Code of Federal Regulations Title 21 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 21 CFR Part 211
The requirements for FDA 21 CFR Part 211 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 prove to the FDA 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. Once all requirements are met, the manufacturer may then seek authorization of 21 CFR Part 211 compliance, allowing them to handle finished drug products for services such as kitting and packaging within their facility.
Is Gilero Compliant with 21 CFR Part 211?
Gilero expects to earn 21 CFR Part 211 compliance by October 2021. Our manufacturing facility in Pittsboro, NC abides by current Good Manufacturing Practices and has been working towards 21 CFR Part 211 compliance in order to better serve our pharmaceutical customers. With this compliance, Gilero will be able to handle finished drug products, expanding our drug kitting and packaging capabilities 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!