CERTIFICATION IN INDIA

WHO GMP CERTIFICATION

What is WHO GMP?

Good Manufacturing Practices (GMP, also referred to as ‘cGMP‘ or ‘current Good Manufacturing Practice‘) is the aspect of quality assurance that ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the product specification.

GMP defines quality measures for both production and quality control and defines general measures to ensure that processes necessary for production and testing are clearly defined, validated, reviewed, and documented and that the personnel, premises, and materials are suitable for the production of pharmaceuticals and biologicals including vaccines.

GMP also has legal components, covering responsibilities for distribution, contract manufacturing and testing, and responses to product defects and complaints. Specific GMP requirements relevant to classes of products such as sterile pharmaceuticals or biological medicinal products are provided in a series of annexes to the general GMP requirements.

Benefits of WHO GMP Certification

Prevent Damage to Health

Avoid Harmful Skin Conditions

Defined and Controlled Hygiene Protocols

Improved Processes and Production Environment.

Cut Profit Loss

Boost Export Opportunities

Who can be certified WHO GMP Certification?

Food & Beverages

Cosmetics

Pharmaceutical Products

Dietary Supplements

Shamkris Group

Medical Devices

Document required for WHO GMP Certification

The extent of Documented Information differs as per:

Role of Shamkris and Process of WHO 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 Practices
 
Good Manufacturing Practices (GMP, also referred to as ‘cGMP’ or ‘current Good Manufacturing Practice’) is the aspect of quality assurance that ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the product specification 
Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards.

Joint Commissioner (HQ) is authorized by Commissioner, Food & Drug Administration, Maharashtra State, to sign & issue the certificates under the WHO-GMP certification scheme online.