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