21 CFR 211 – cGMP for Finished Pharmaceuticals

Worldwide USFDA establishment registered facilities are Inspected / Audited by FDA inspectors. The number of facilities are increased 20% more compared to previous years. FDA inspectors demands 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 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 When applicable regulations conflict, general requirements are superseded by drug-specific GMP requirements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 clauses 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 GMP manufacturing solutions in the medical device and pharmaceutical industries provide supporting services for those to be audit by FDA or planning for Establishment Registration and 21 CFR 211 compliance.

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 (400 USD/man-day + Travel + Accommodation)
Option 03: Closing of 483’s (400 USD /483)

Note: Option 02 consultants has to travel either from Chicago, USA or Bangalore, India.

We also provide service for Q7 Implementation for API’s

Link to FDA. Click here>>>

 

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