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FDA 21 CFR 211
FDA 21 CFR 211 details current Good Manufacturing Practices (cGMP) requirements of finished pharmaceuticals by the FDA.
FDA inspectors demand full compliance with GMP requirements as per 21 CFR 211. Anything less than complete adherence will cause the manufacturers the stamp of “adulterated” or “misbranded” in the eyes of the FDA.
Compliance with the 21 CFR 211 guidelines for finished pharmaceuticals is necessary to ensure finished drug products meets the specification in terms of safety, quality, strength, and purity.
Full compliance to 21 CFR 211 requirements is mandatory for FDA registered establishments shipping drugs to the United States. Anything less or partial compliance with the standard will be put under the banner of “adulterated” or “misbranded” drugs.
FDA Pre-Inspection and Role of I3CGLOBAL Consultants
21 CFR 211 requirements are tough to interpret correctly and judge how each one has to be actually implemented on the floor. An experienced consultant can guide and solve such 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 activities for the first timers:
- Process owners 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 Quality Manual
- Development of mandatory procedures and important templates
- Development organization structure and roles & responsibility
- Join and conduct Internal Audit
FDA Post-Inspection and Role of I3CGLOBAL Consultants
This service is designed to suit manufacturers who have completed an FDA inspection and single or multiple findings. Our team of experts 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
21 CFR 211 Consulting Service Fees
Our technical experts and consultants travel across the globe from Germany, India & USA. We do NOT have representation in any other location. The tentative fees are detailed below:
- 21 CFR 211 Implementation Support starts at 6500 USD ( Fees will vary between travel time, number of products, shop-floor manufacturing area, etc.)
- Post Inspection Service – 1000 USD – 3000 USD / Observation / 483’s.
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21 CFR 211 - What will be the estimated time for implementation?
- Quality and Experience of technical staff
- Level of documentation followed
- Number of products manufactured
- Facility Size
- Facility and Environments
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 Initial response to FDA with a clear and actual plan for closing the 483’s.
- Identify process owner and develop an action plan with a firm timeline for closing the NC’s