WHO GMP CERTIFIED
The “World Health Organization (WHO)” is a specialized agency of the “United Nations (UN)” that is concerned with international public health. WHO addresses government health policy with two aims:
Firstly, “to address the underlying social & economic determinants of health through policies and programs that enhance health equity and integrate pro-poor, gender-responsive, and human rights-based approaches” and secondly “to promote a healthier environment, intensify primary prevention and influence public policies in all sectors so as to address the root causes of environmental threats to health”.
It is often referred to as the certification against the ISO 9001:2008 standard. The “ISO” certificate is awarded to the organization for showing the compliance at the times of certification audits against the said standard.
The organization has to Establish, Document, Implement and Maintain and Monitor the management system before proceeding for the certification audit. The certification audit is conducted by the selected Certification Body or the Conformity Assessment Body. However, it is not mandatory to opt for the certification audit to implement the said standard.
GMP – GOOD MANUFACTURING PRACTICE
“Good manufacturing practice” or “GMP” is part of a quality system covering the manufacture and testing of active pharmaceutical ingredients, diagnostics, foods, pharmaceutical products, and medical devices.
GMPs are guidelines that outline the aspects of production and testing that can impact the quality of a product. Many countries have legislated that pharmaceutical and medical device companies must follow GMP procedures, and have created their own GMP guidelines that correspond with their legislation.
GLP – GOOD LABORATORY PRACTICE
“GLP – GOOD LABORATORY PRACTICE “Good Laboratory Practice” (GLP) is an internationally recognized set of principles, which provides a framework within which laboratory studies are planned, performed, monitored, recorded, reported and archived.
Laboratories undertake studies to generate data, on the basis of which, hazards and risks to users, consumers and others including environment, can be assessed. Studies can be conducted on a variety of subjects including pharmaceuticals, agro-chemical, veterinary medicines, industrial chemicals, cosmetics, food, food additives and biocides.
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