CERTIFICATION IN INDIA

Current Good Manufacturing Practices (cGMP)

What is cGMP?

In the United State, Current Good Manufacturing Practices known as CGMP, refer to legislation that falls under the purview of the U.S. Food and Drug Administration (FDA).

These laws ensure that all pharmaceuticals and most food and beverage, cosmetic, and dietary supplement companies follow industry and best practices like hygiene, quality control, and more to ensure all products manufactured are safe and effective.

Current Good Manufacturing Practices are not limited to companies located within the U.S. Foreign companies that produce food, medical, and cosmetic products for distribution in the U.S. must comply with these standards.

The World Health Organization (WHO) has Good Manufacturing Practice guidance in place for pharmaceuticals and biological medicinal products. While the WHO is a separate organization from the FDA, these guidelines help ensure the global supply of medication and medical products meets safety guidelines.

Benefits of cGMP Certification

Product Quality

Safety Assurance

Reduce safety risk in product quality

Improves customer confidence

Improves efficiency and lower costs

Timely detect production and management problems

Who can be certified cGMPD Certification?

Foods

Cosmetics

Dietary Supplements

Beverages

Storage

Packaging

Document required forcGMP Certification

The extent of Documented Information differs as per:

Role of Shamkris and Process of cGMP Certification

Shamkris adopts a results-oriented approach to effective system implementation in the organization. A simple and practical method of system implementation helps organizations increase business efficiency and sustainability. Shamkris supports 100% documentation to obtain an accreditation body of success in addition to enhanced performance.

The implementation process is described below:

Time Frame

Task

Process

Day 1

GAP Analysis
Certification Body
Selection
Cost Estimates

Week 1

Developing Documents

Week 4

Implementing Management System

Week 8

Internal Audit
MRM
CAPA

Week 10

Certification Body
Audit
N-C Closing

Week 12

Certification Body

Year on Year

Yearly Compliance

FAQ

Current good manufacturing practices (CGMPs) are general practices and procedures recommended by the Food and Drug Administration (FDA) to ensure product safety and quality. … CGMPs help prevent food safety hazards in your facility and ensure that your food products are safe to eat.
CGMP refers to the Current Good Manufacturing Practice regulations enforced by the FDA. CGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities.
CGMPs can be applied to any food manufacturing, packing or storage operation, regardless of the type of food or manufacturing process. In contrast, each HACCP control plan is specifically designed for a particular food or a related group of foods or food processes.
 

CGMP is the main regulatory standard for ensuring pharmaceutical quality. This includes over-the-counter and prescription small-molecule drugs and biopharmaceuticals like vaccines, therapeutic blood products, gene therapies, antibodies and cell therapies (e.g. stem cell therapies).