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Good Laboratory practice
Good Laboratory practices in Pharmaceutical industry
Document No.: GLP/00001
Table of content




WHO Good document practice

The need to implement quality standards in drug research, development and testing; the situation in developing countries and the role of WHO/TDR Tropical diseases are a major public health problem in developing countries (Disease Endemic Countries – DECs). For many of these diseases no new, effective and affordable medicines have been developed, while older therapeutic agents are increasingly compromised by the emergence of resistance. Because multinational

pharmaceutical companies have not traditionally focused on tropical disease research and development (R&D), WHO has initiated R&D programmes in a number of priority areas such as malaria. WHO’s Special Programme for Research and Training in Tropical diseases (TDR) commissions studies to be conducted in the geographical regions most affected by such diseases. If such R&D is to result in marketing approval of effective and safe new drug products, the component studies must comply with current research practice standards ensuring the quality, reliability and integrity of study data. Market authorisation regulations require that quality standards, i.e. Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and Good Clinical Practice (GCP), are followed in the respective stages of the development and life-cycle of a drug product

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INTRODUCTION

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HYPOTHESIS

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MATERIALS

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Good document practices in pharmaceutical industryhttps://www.publicdomainpictures.net/pictures/40000/nahled/question-mark.jpg


What is good documentation practices?
Good documentation practice (commonly abbreviated GDP, recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained. While some GDP / GDocP standards are codified by various competent authorities, others are not but are considered cGMP (with emphasis on the "c", or "current"). Some competent authorities release or adopt guidelines, and they may include non-codified GDP / GDocP expectations. While not law, authorities will inspect against these guidelines and cGMP expectations in addition to the legal requirements and make comments or observations if departures are seen. In the past years, the application of GDocP is also expanding to cosmetic industry, excipient and ingredient manufacturers.

Key point to be remember
🔑Good document practice to be follow
🔑Good document practice to be follow
🔑Good document practice to be follow
🔑Good document practice to be follow, Good document practice to be follow Good document practice to be follow Good document practice to be follow Good document practice to be follow
nt practice to be follow Good document practice to be follow

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