FDA 21 CFR Part 210 and 211:
CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS
- Subpart A–General Provisions.
- Subpart B–Organization and Personnel.
- Subpart C–Buildings and Facilities.
- Subpart D–Equipment.
- Subpart E–Control of Components and Drug Product Containers and Closures.
- Subpart F–Production and Process Controls.
- Subpart G– Packaging and Labeling Control
- Subpart H– Distribution and Holding.
- Subpart I–Laboratory Controls.
- Subpart J– Reports and Records.
- Subpart K–Returned and Salvaged Drug Products.
Operon Strategist helps in maintaining compliance with 21 CFR 210 and 211 which is critical to the pharmaceutical industry. This includes observation of current good manufacturing practice (cGMP) by understanding and planning the processes and methods defined in FDA Guidelines. We also help in the development of training modules for comprehension to various parts of the regulations, and also in the guide in strategic review and assessment of the organization for personal optimization.
We also help our client In-depth system audits and recommendations for improvements, site inspection preparation activities and mock inspections.