21 CFR 211

Current good manufacturing practice for finished pharmaceuticals

Worldwide USFDA Drug Establishment registered facilities are Inspected and by FDA. The number of facilities is increased 20% more compared to previous years.

FDA inspectors demand full compliance with GMP requirements as per 21 CFR 211. Anything less than complete adherence will cause manufactures the stamp of “adulterated” or “misbranded” in the eyes of the FDA.


Failure to comply could lead to disruptive regulatory action against a company. Many of the manufactures registered with FDA does not know what extent is compliance required?


21 Part 210 outlines minimum Good Manufacturing Practices (GMP) in manufacturing, processing, packing or holding of all type of drugs under the preview of the FDA, while CFR Part 211 refers specifically to the GMP requirements of finished pharmaceuticals.
When applicable regulations conflict, general requirements are superseded by drug-specific GMP requirements

Manufactures find difficult to correctly interpret how each clause has to be satisfied as per FDA inspectors. This kind of ambiguity, whether intended or not, regarding what the FDA inspectors will enforce in terms of GMP compliance, and what it merely recommends or desires.


This degree of uncertainty makes it vital for knowledgeable and experienced hands to be involved in guiding and interpreting standard and in the decision making process dealing with compliance issues.

I 3 CONSULTING team of hard core regulatory professionals well over 12 to 22 years of international experience in US FDA 21 CFR 211 compliance consulting for OTC & Generic drugs. Our compliance service includes the following.

US FDA 21 CFR 210 and 21 CFR 211 Guidance and Compliance consulting.

  • US FDA 21 CFR 211 Pre Inspection / Audit.
  • US FDA 21 CFR 211 Post Inspection Consultation.
  • US FDA 21 CFR 211 Post Inspection 483 Response preparation and submission.
  • US FDA 21 CFR 211 483 Response, Guidance on closing CAPA and Follow up with FDA.

Contact them to discuss your needs in meeting FDA compliance in any of the following:

  • Option 01: Regular Implementation
  • Option 02: FDA Pre-Audit Inspection GAP Analysis and Guidance (500 USD/man-day + Travel + Accommodation)
  • Option 03: Closing of 483’s (500 USD /483)

Note: Option 02 Consultants will be travelling from nearest office location [Chicago, USA or Cologne, Germany or Bangalore, India]

We also provide service for Q7 Implementation for API’s

Link to FDA. Click here>>>

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