Good Laboratory Practices in Pharmaceutical
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About this ebook
This Book contains the basic requirements which is required in Quality Control Laboratory
Chandrasekhar Panda
The Author of this Book is Mr Chandrasekhar Panda with Educational Qualification of Bachelor of Pharmacy with more than 17 years of Experience in Pharmaceutical Industry Quality Assurance.
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Good Laboratory Practices in Pharmaceutical - Chandrasekhar Panda
What is Good Laboratory Practice (GLP):
Good Laboratory Practice contains a set of principles that provides a framework within which laboratory studies (Activities) are planned, performed, monitored, recorded, reported and archived. GLP help assure regulatory authorities that the data submitted are a true reflection of the results obtained during the study and can therefore be confidence upon when marking risk/safety assessment.
Good Laboratory Practices (GLP) was first introduced in New Zealand and Denmark in 1972, and later in the US in 1978. 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 promote GLP to many countries.
GLP is not only limited to chemicals but also it applies to medical devices, food additives, food packaging, colour additives and other non-pharmaceutical products or ingredients as well.
Why GLP is Important in Pharmaceuticals:
Good Laboratory Practice contains different principles which are designed to ensure and promote consistency, quality, safety, reliability and integrity of chemicals during non-clinical and laboratory testing. In the field of Life Sciences, whether it’s in Research and Development or manufacturing, conducting proper testing is crucial for ensuring that the foundation of Good Manufacturing Practices (GMP) and product assessment is logically and scientifically sound.
Testing is a must