CERTIFICATION IN INDIA

GLP CERTIFICATE - GOOD LABORATORY PRACTICES

What is GLP?

In the experimental (non-clinical) research arena, good laboratory practice or GLP is a quality system of management controls for research laboratories and organizations to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of products in development for human or animal health (including pharmaceuticals) through non-clinical safety tests; from physiochemical properties through acute to chronic toxicity tests.

GLP was first introduced in New Zealand and Denmark in 1972, and later in the US in 1978 in response to the Industrial BioTest Labs scandal. It was followed a few years later by the Organization for Economic Co-operation and Development (OECD) Principles of GLP in 1992; the OECD has since helped promulgate GLP to many countries.

Benefits of GLP Certification

Increased confidence in the reliability and trustworthiness of laboratory data

Increased production of right first time results.

Increased overall productivity.

Increased laboratory reputation.

Reduced need for re-work

Reduced time spent on non-revenue earning investigations.

Who can be certified GLP Certification?

Food Additives

Shamkris Group

Food Packaging

Shamkris Group

Colour Additives

Animal Food Additives

Non-Pharmaceutical Products

Ingredients

Shamkris Group

Biological Products

Shamkris Group

Electronic Products

Document required for GLP Certification

The extent of Documented Information differs as per:

Role of Shamkris and Process of GLP 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 laboratory practice or GLP is a set of principles intended to assure the quality and integrity of non-clinical laboratory studies that are intended to support research or marketing permits for products regulated by government agencies.

GLP Recognition

Compliance with the OECD GLP principles helps ensure that non-clinical studies follow internationally accepted requirements.

GLP helps to ensure the credibility and traceability of data submitted, thereby addressing the issue of non-reproducibility in many biopharmaceutical experiments. GLP is intended to minimise adverse drug effects and improve human health and environmental safety profiles.