The Pharmaceutical Regulatory Process 2nd Ed. by Ira R. Berry, Robert P. Martin

17th July 2011
Sunday 11;25 AM
Banaras

This book provides in-depth coverage of the procedures utilized by pharmaceutical companies for regulatory compliance, this reference describes the history and development of regulations, standards, and guidelines that affect pharmaceutical product approval and commercial sale in the

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Pharmaceutical Regulatory Process by Ira R. Berry, Robert P. Martin

This Second Edition examines the mechanisms and means to establish regulatory compliance for pharmaceutical products and company practices. It focuses on major legislative revisions that impact requirements for drug safety reviews, product regulatory approvals, and marketing practices. Written by top industry professionals, practicing attorneys, and FDA regulators, it includes policies and procedures that pharmaceutical companies need to implement regulatory compliance post-approval.

New chapters cover:

*the marketing of unapproved new drugs and FDA efforts to keep them in regulatory compliance
*pharmacovigilance programs designed to prevent widespread safety issues
*legal issues surrounding the sourcing of foreign APIs
*the issues of counterfeit drugs
*updates on quality standards

Handbook of Good Laboratory Practice (GLP) by WHO

17th July 2011
Sunday 11:04 AM
Banaras
Good laboratory practices (GLP) are the recognized rules governing the conduct of non-clinical safety studies. They ensure the quality, integrity and reliability of the study data.Here is the book published by WHO.

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Handbook of Good Laboratory Practice (GLP) by WHO

This Second-edition GLP Handbook contains all of the required support material for
implementing GLP in a laboratory. The handbook comprises four parts, all updated,
including: 1) explanation of the fundamentals of GLP; 2) support for GLP training; 3) methodology for GLP implementation in DEC research institutions; 4) GLP principles and guidance produced by the Organisation of Economic Co-operation and Development (OECD), and reproduced here with OECD permission.

Good Laboratory Practice Regulations 4th Ed. by Sandy Weinberg

17th July 2011
Sunday 10:38 AM
Banaras

Its pleasant whether in Banaras today on sunday morning. Recent changes in the interpretation and enforcement of 21 CFR Part 11 have shifted the focus of Good Laboratory Practice (GLP) regulations to concentrate on the acceptance of electronic signatures, the archiving of data, the security of electronic documents, and the automation of laboratory procedures. This books covers all this aspects.

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Good Laboratory Practice Regulations by Sandy Weinberg

This Fourth Edition of the book addresses every critical aspect of Good Laboratory Practice (GLP) regulations and demonstrates effective strategies for implementation in a variety of laboratory settings. This updated and expanded classic text contains new information about applying 21 CFR Part 11 to the laboratory environment, GLP documentation systems, laboratory risk analysis, system validation and inspection, process analytical technologies, and cost control for the prevention of pitfalls and the assurance of compliance in numerous research environments.

Law and Ethics in Pharmacy Practice by Ruth Rodgers, Catherine Dewsbury, Andrew Lea

15th July 2011
Friday 07:48 PM
Banaras

Pharmacy law and ethics, along with the knowledge of drugs and their uses, forms the foundation upon which professional pharmacy practice is built.

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Law and Ethics in Pharmacy Practice by Ruth Rodgers, Catherine Dewsbury, Andrew Lea

This text covers all main areas of law related to pharmacy practice and gives concise information on the law as well as putting the law into practice. It will also give concise information on the current code of ethics and give practical case scenarios with various option outcomes.

The Drugs and Cosmetics Act of India

15th July 2011
Friday 04:00 PM
Banaras

Hi! The object of the Drugs and Cosmetics Act 1940 is to regulate the import, manufacture, distribution and sale of drugs.Here is a very important book for Drug and Cosmetic Acts.

Download Link: http://www.filefactory.com/file/b3ae5c9/n/Drugs_amp_Cosmetic_Act.pdf

The Drugs and Cosmetics Act of India

An Act to regulate the import, manufacture, distribution and sale of drugs 2[and cosmetics]; WHEREAS it is expedient to regulate the 3[import, manufacture, distribution and sale] of drugs 2[and cosmetics];

AND WHEREAS the Legislature of all the Provinces have passed resolutions in terms of section 103 of the Government of India Act, 1935 (26 Geo. 5, c.2), in relation to such of the above-mentioned matters and matters ancillary thereto as are enumerated in List II of the Seventh Schedule to the said Act.