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GMP Certificate

Good Manufacturing Practice (GMP) applicable for all healthcare manufactures such as API's, Drugs, Diagnostics, Food, Netraceutical, Medical Device & Cosmetics. Respective country guidelines the requirments to be followed for the type of products manufactured based on the impact the quality of a product can be affected.

Department of Health and Human Services, U.S. Food and Drug Administration under title 21 of Code of Federal Regulations part 111/820/210 describes about GMP.

The goal of GMP is to ensure that products have consistent and controlled production according to quality standards. Companies must fulfill several requirements to get GMP certification.

Will USFDA Issue GMP Certificate?

USFDA never issue GMP Certificate.

How can my firm Implement GMP?

# Identify the relevent guidline based on the product you manufacturer and country of orgin.

# Appoint an experienced consulting company like I 3 CONSULTING for guidance, Training and Implementation support.

# Develop Quality Mnaual, Procedures, Templets.

# Follow procedures and maintain records for each activity which effects Finished product Quality.

# Conduct Internal Audit to identify GAPS in the Good Manufacturing Practice.

Who will issue GMP Certificate?

Contact any of the government approved agencies or Certification Bodies.

What will be the tentative cost of GMP Certification?

Costing depends on Shopfloor area, Number of Employees, Type of product manufactured, Number of shifts, Number of locations etc. The major GMP Certification costs are the following.

# Guidance and Consulting Fees.

# Auditng Fees.

# GMP Certificate Fees.

# Auditor Travlelling & Accomodation.

How long the process of GMP Certification?

# Documentation & Implementation normally 3-4 months.

# Application Scrutiny, 1 month.

# Auditing and Issue of GMP Certificate, 1 month approximately.

Which Domains I 3 CONSULTING is experts to help us get GMP Certificate?

I 3 CONSULTING has a pool of experienced consultants with previous experienced in different domains. Based on the client requirment and (a) type of products manufactured (b) country of marketting intrest, we identify the consultant and allocate the project.

INDIA - Bangalore
+ 91 994 591 2081
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USA - Chicago
+1 630 696 1293
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GERMANY - Bremen
+49 (0) 2161 9908831
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enquiry@i3cglobal.com

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