CERTIFICATION IN INDIA

GMP CERTIFICATION - GOOD MANUFACTURING PRACTICES

What is GMP?

GMP stands for Good Manufacturing Practice, & the term is used globally for managing the control and management of manufacturing, testing, and overall quality of pharmaceutical products. It defines certain guidelines that talk about the quality assurance approach. GMP certification ensures that products are produced following the quality standard norms.

Joint Commissioner is authorized by Commissioner, Food & Drug Administration, to sign & issue the certificates under the WHO-GMP certification scheme. GMP certification deals with issues like documentation, record keeping, personnel qualifications, sanitation, cleanliness, equipment verification, sanitation, complaint handling, and process validation.

GMP requirements are not peculiar in any sense instead they are open-ended and easy to implement also these requirements give liberty to the manufacturer to decide individually how to efficiently implement the necessary controls.

Benefits of GMP Certification

Empower certification holders to opt great creation

Helps boost export opportunities

Compliance with important laws and guidelines

Improve overall credibility and public image

Reduce safety risk in product quality and safety

Cost saving

Who can be certified GMP Certification?

Food & Beverages

Cosmetics

Pharmaceutical Products

Dietary Supplements

Shamkris Group

Medical Devices

Document required for GMP Certification

The extent of Documented Information differs as per:

Role of Shamkris and Process of GMP 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

Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.

Joint Commissioner is authorized by Commissioner, Food & Drug Administration, to sign & issue the certificates under the WHO-GMP certification scheme. GMP certification is given based on a finished GMP assessment of a producer working as per the GMP guidelines. The authentication is given that satisfactory documentation on the examination follow-up is submitted.

The application for GMP certification must be made by an approved individual within the organization looking for the confirmation. This is typically one with obligation, for example, a Production Manager, a Quality Assurance Manager, a Quality Control Manager or the Managing Director.