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21 CFR Part 211

21 CFR Part 211 - GMP for Finished Formulations

21 CFR Part 211 details the current good manufacturing practice (cGMP) requirements of finished pharmaceuticals by the FDA. It ensures the quality of finished drug products meets the specification in terms of safety, quality, strength, and purity by carefully monitoring drug manufacturers’ compliance with its cGMP instructions.

 

21 CFR Part 211 details the minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing the drug product. The regulations make sure that a product is safe for use and that it has the ingredients and strength it claims to have. FDA inspectors demand full compliance with GMP requirements as per CFR 211. Anything less than complete adherence will give the manufacturer the stamp of “adulterated” or “misbranded.”.

 

Full compliance with guidelines is mandatory for manufacturers, including new and generic drug marketing applications and private label distributors shipping drugs to the United States. Anything less than or in partial compliance will be put under the banner of “adulterated” or “misbranded” drugs.

21 CFR Part 211 Guidelines For Pharmaceuticals

21 CFR Part 211 guidelines are tough to interpret correctly and judge how each one has to be actually implemented on the floor. An experienced regulatory consulting company, we can guide and solve this kind of ambiguity. This makes it vital that knowledgeable and experienced technical experts’ hands be involved in the standard interpretation and compliance issues.

 

Following are the requirements for the first-timers:

  • Process owner interaction
  • Preliminary gap assessment
  • Retrospective analysis across all processes covering document management, data management, reports, etc.
  • Development of a comprehensive action plan for closing identified gaps
  • Development of a Quality Manual
  • Development of mandatory procedures and important templates
  • Development organization structure and roles and responsibilities
  • Join and conduct an internal audit.

US FDA Post-Inspection Consulting and Closing of Observations and Findings

This service is designed to suit manufacturers who have completed an FDA inspection with single or multiple findings. Our team of expert 21 CFR Part 211 Consultants can be helpful in the following ways:

  • Preliminary root cause analysis for the FDA findings/observations.
  • Development of CAPA plan after a thorough understanding of root cause
  • Drafts initial response to the FDA with a timeline
  • Plans, Monitors, Reviews and guides objective evidence collected as part of CAPA

Service Fee for 21 CFR Part 211 Consultants

Our technical experts and consultants travel across the globe from Germany, India, and the USA. We do not have representation in any other location. The tentative 21 CFR Part 211 fees are detailed below:

  • Drafting of the quality manual, mandatory procedures, and important record templates: 2500 USD in 14 working days
  • Implementation support starts at 8500 USD (fees will vary depending on travel time, number of products, shop-floor manufacturing area, etc.).
  • FDA response/closing observation/483’s: 1000 USD–3000 USD per NC, depending on the gravity of the NC.

Frequently Asked Questions

What will be the estimated time for FDA 21 CFR Part 211 implementation?

The 21 CFR Part 211 implementation timeline depends on the following factors, but generally, 4-6 months are considered appropriate for mid-sized organizations.

 

  • Quality and experience of technical staff
  • The level of documentation followed
  • Number of products manufactured
  • Facility Size
  • Facility and environment

Important areas and clauses of 21 CFR 211

  • Sub-part A: General Provisions
  • Sub-part B: Organization and Personnel
  • Sub-part C: Buildings and Facilities
  • Sub-part D: Equipment
  • Sub-part E: Control of Components and Drug Product Containers and Closures
  • Sub-part F: Production and Process Controls
  • Sub-part G: Packaging and Labeling Control
  • Sub-part H: Holding and Distribution
  • Sub-part I: Laboratory Controls
  • Sub-part J: Records and Reports
  • Sub-part K: Returned and Salvaged Drug Products

FDA Post Inspection and Consultants role in handling 483's

  • Understand 483 and identify the root cause.
  • CAPA initiation, with the joint support of multiple departments and QA
  • Submit an initial response to the FDA with a clear and actual plan for closing the 483s.
  • Identify the process owner and develop an action plan with a firm timeline for closing the NCs.