21 CFR Part 210 | 211 Quality Assurance -Operon Strategist

 In the 21 CFR Part 210 and 211, 21 CFR Part 210 deals with the Manufacturing, Processing, Packaging or  Holding of drugs, while 21 CFR Part 211 deals with finished pharmaceuticals. This cGMP Guidance related to the pharmaceutical and drug-related industry.

21 CFR Part 210 and 211

The move was in response to concerns about substandard drug manufacturing practices at the time. The 1962 Drug modification brought modern quality assurance and control principles to drug manufacturing. The word “current” was later added to make it “CGMP” (or cGMP) to imply that the regulation allows for changing technology in attaining GMP.

Operon Strategist helps in maintaining compliance with 21 CFR Part 210 and 21 CFR Part 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.

Read More -  21 CFR Part 210 and 211

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Contact details –

Phone  no -  93702 83428

Mail id – enquiry@operonstrategist.com

If  You Want Medical Devices Services Consultation For Following.

1. Medical Device Consulting 
2. cdsco registration 
3. FDA 510k Clearance 
4. ce mark medical device 
5. CDSCO Manufacturing License 
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8. medical device manufacturing 
9. iso 15378 certification 
10. 21 cfr part 210 and 211 
11. ISO 13485 Medical Device Consultant 
12. Primary Packaging Turnkey Project Consultant 
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