21 CFR 111
FDA 21 CFR 111 regulation detailed about Good Manufacturing Practice (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. We are the US FDA consultants for supporting Food Supplements manufacturers to implement 21 CFR 111.
21 CFR 110
Current GMP is for those involved in manufacturing, packing or holding human food.
21 CFR 111
Current GMP is for those involved in manufacturing, packing or holding human food supplements. The regulation must be followed by all domestic and foreign companies involved in the manufacturing, testing, packaging, labeling, warehousing of dietary supplements, including those involved with testing, quality control, and dietary supplement distribution in the U.S.
Why I3CGLOBAL should be preferred for FDA Pre-Inspection Support?
Generally, the FDA intimate the owner/operator of registered facility about the inspection at-least 2 months in advance. Followed by the intimation, manufactures/regulatory team will be in a hurry to make everything to be aligned with 21 CFR requirements.
I3CGLOBAL team has successfully supported hundreds of companies across the globe in this gesture by providing technical solutions such as:
- Documentation review and guidance
- Facility Inspection and Guidance
- Environmental Controls
- Quality Control & Quality Assurance compliance
- Batch Tractability & Recall
Our consultants are located in Germany, India & USA.
- CFR Implementation start @ $4500. ( Fees depends on type of products, shop-floor area, number of employees etc.
- Pre-Inspection $450 / man-day + Travelling and Accommodation.
- Post Inspection service based on number of Observation. The fees for closing per observation /483 is $1000
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What is the expected time required to complete cGMP as per 21 CFR 111?
There are various factors which decides the time line, few are the following
- Type of products manufactured
- Number of products manufactured in the same facility
- Shop floor area
- Technical Skill and understanding capabilities of employees
- Equipment’s and utensils used
- Air handling system
- Shop-floor layout
- Disposal of waste etc.
Is there any need of manual and procedures?
- Quality Manual
- Mandatory Procedures
- Standard Operating Procedures
- Validation Protocols and records
- Batch Manufacturing Records
- Quality Plans
- Test Reports etc..