A COMPREHENSIVE REVIEW ON COMPARISON OF GDOCP IN PHARMACEUTICAL MANUFACTURING UNIT AS PER EUROPEAN AND WHO GUIDELINES
Keywords:Good documentation practice, European union, World health organisation, Regulatory authorities
To review the good documentation practices in the pharmaceutical industry as per the guidelines provided in the European Commission and WHO (World Health Organisation). GDocP is a systematic method of planning, evaluating, approving, issuing, documenting, preserving, and archiving records. GDocP is a must when operating in an atmosphere of existing GMP. To provide an overview of good documentation practices for those employed in the pharmaceutical and healthcare sectors. The GDocP stands for good documentation practice which can be described as an integral part of quality assurance (QA) and thus related to all aspects of GMP. There are very few articles related to the comparison of GDocP in the pharmaceutical manufacturing unit as per European and WHO guidelines hence we are trying to develop a study on the comparison of GDocP guidelines. Public and private organizations, institutions, and regulatory authorities working and cooperating and with the pharmaceutical industry are involved at the international and national level to reach a consensus on the guidelines and laws for the production of medicinal products for human. This article explains how these participants work and cooperate and set out current regulations along the lines of the European community and WHO referencing, where appropriate, the practiced guidelines, outside space regulatory action referred to above. In this way, the goal is to achieve exceptional standards of quality, protection, and efficacy in the manufacture of health products.
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