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21 CFR 211, Good Manufacturing Practices
21 CFR 211 details current Good Manufacturing Practice (cGMP) requirements of finished pharmaceuticals by the FDA. FDA 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 Current Good Manufacturing Practice (CGMP) instructed in 21 CFR 211.
The 21 CFR 211 details minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing for the drug product. The CFR 211 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 cause the manufacturers the stamp of “adulterated” or “misbranded”.
Full compliance to 21 CFR 211 requirements is mandatory for manufactures includes new and generic drug marketing applications and private label distributors shipping drugs to the United States. Anything less or partial compliance with the 21 CFR 211 will be put under the banner of “adulterated” or “misbranded” drugs.
FDA Pre-Inspection Consulting & Implementation Support
21 CFR Part 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 Consulting
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 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:
- Drafting of Quality Manual, mandatory procedures and important record templates : 1500 USD in 14 working days
- Implementation Support starts at 6500 USD ( Fees will vary between 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 NC.
What will be the estimated time for implementation?
21 CFR 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
- Level of documentation followed
- Number of products manufactured
- Facility Size
- Facility and Environments
Important areas and clauses of 21 CFR Part 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