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Sunday, April 18, 2010

Biochemic drug assay methods

Biochemic drug assay methods.
By Paul Stewart Pittenger

  • Publisher: University of Michigan Library
  • Number Of Pages: 220
  • Publication Date: 1914-01-01
  • ISBN-10 / ASIN: B003156NB6
  • ISBN-13 / EAN:

Product Description:

This volume is produced from digital images created through the University of Michigan University Library's large-scale digitization efforts. The Library seeks to preserve the intellectual content of items in a manner that facilitates and promotes a variety of uses. The digital reformatting process results in an electronic version of the original text that can be both accessed online and used to create new print copies. The Library also understands and values the usefulness of print and makes reprints available to the public whenever possible. This book and hundreds of thousands of others can be found in the HathiTrust, an archive of the digitized collections of many great research libraries. For access to the University of Michigan Library's digital collections, please see http://www.lib.umich.edu and for information about the HathiTrust, please visit http://www.hathitrust.org.

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Pharmaceutical Stability Testing to Support Global Markets (Biotechnology: Pharmaceutical Aspects)

Pharmaceutical Stability Testing to Support Global Markets (Biotechnology: Pharmaceutical Aspects)
By Kim Huynh-Ba

  1. Publisher: Springer
    1. Number Of Pages: 268
    1. Publication Date: 2009-12-17
    1. ISBN-10 / ASIN: 1441908889
    1. ISBN-13 / EAN: 9781441908889

  2. Download Link:

Thursday, April 8, 2010

Useful Pharmaceutical Links

Analytical Method Development
Analytical Method Validation
Validated analytical method only can give accurate results. Validation of analytical method is must for pharmaceutical analytical laboratory.
There is guideline for analytical method validation from ICH & US FDA.
ICH-Q2(R1)- Validation of Analytical Procedures - Text and Methodology
US FDA draft guidance on analytical procedures & method validation
EDQM guideline

EDQM-Validation of analytical procedure

Analytical Method Transfer

There is no definite guidance from USFDA on this subject. Recently USP has come up with a stimuli article on this subject. For more information refer the link below.
Transfer of analytical procedures-A new general information chapter

Instrument calibration
1. Disolution Apparatus 1 & 2 - Mechanical calibration
2. Prednisone tablet for PVT - New lot - P1I303

Instrument Qualification

Annex 1: Qualification of HPLC Equipment

Annex 2: Qualification of GC Equipment

Annex 3: Qualification of UV-Visible Spectrophotometers

Annex 4: Qualification of IR Spectrophotometers

Result & Reports
Out-Of-Specification (OOS)
Investigation is must for any product failures to find out the root cause and Corrective And Preventive Action(CAPA). USFDA come up with definite guidance on this subject. This guideline helps to handle OOS data and procedure for investigation. For more information refer the below link.

Out-Of-Trend(OOT) Analytical Results
An analytical result which fall in with in the specification limit but does not follow with in the trend or unexpected result. Normally any analytical result which fall in Out-Of-Specification requires a detailed investigation to find a root cause failure and folowed by a currettive And Preventive Action(CAPA).
Though regulation demands investigation to be completed with in thirty days but most of the cases industries fails to complete the invsetigation with in stipulated period to find root cause.Meanwhile its end up with few more failures. To avoid such things happen the current practice starts investigation when results appear to be ou-of-trend.
The following links help to know more about OOT
Auditing pharmaceuticals quality control Laboratory

Auditing quality control laboratory is must for continuous improvement and regualotory requirements. It helps to keep QC laboratory in high compliance level and maintain best practices through continuos improvement by training and gap analysis.

There is a guideline from US FDA for inspection pharmaceuticals QC laboratory it

includes chemical lab and Micro lab.

Auditing Guide from APIC

Pharmaceutical Quality Control Labs

Audit check list for Pharmaceutical Quality Control Labs by PICScheme

Microbiological Pharmaceutical Quality Control Labs
Guidance document on part 11-Electronic signature & Electronic record

NEW: Annex 1: Validation of computerised calculation systems: example of validation of in-house software - Spread sheet/Microsoft Excel

NEW: Annex 2: Validation of Databases (DB), Laboratory Information Management Systems (LIMS) and Electronic Laboratory Notebooks (ELN)

NEW: Annex 3: Validation of computers as part of test equipment

GAMP 4 to GAMP 5 -Summary

Elemental Impurities—Comments and Responses (1.1MB)

Flow Microscopy—Dynamic Image Analysis for Particle Counting (1.1MB)

A Recombinant Factor C Procedure for the Detection of Gram-negative Bacterial Endotoxin (1.7MB)

High level list of Australian and International pharmaceutical regulations and standards



Australian Code of Good Manufacturing Practice for Medicinal Products – Therapeutics Goods Administration 16 August 2002.

Australian Code of Good Manufacturing Practice for Veterinary Chemical Products – Australian Pesticides & Veterinary Medicines Authority.

Australian Regulatory Guidelines for Complementary Medicines – Therapeutics Goods Administration June 2005.

Australian Medical Device Guidelines – Therapeutics Goods Administration


United States
Code of Federal Regulations 21CFR 210 - cGMP in Manufacturing, Processing, Packing, or holding of Drugs; General – U.S. Food & Drug Administration

Code of Federal Regulations 21CFR 211 cGMP for Finished Pharmaceuticals – U.S. Food & Drug Administration

Code of Federal Regulations 21CFR 600 - Biologics – U.S. Food & Drug Administration

Eudralex Volume 4 - Medicinal Products for Human and Veterinary Use : Good Manufacturing Practice – European Commission

Links to the Associations and Affiliations including general pharma, engineering, scientific and project management.

General Pharmaceutical

  • Pharmaceutical Inspection Cooperation Scheme (PIC/S)
  • World Health Organisation (WHO)

  • Parental Drug Association (PDA) Home Page – Intramuscular and Intravenous drug news and information.

  • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) – scientific and technical aspects of product registration.


  • International Society of Pharmaceutical Engineering (ISPE) Home Page – worlds largest non-profit professional organisation serving pharmaceutical and biotech manufacturing professionals.
  • Engineers Australia Home Page – Revised and updated Institution of Engineers Australia (IEAust) Home Page. General information and news for all aspects of engineering in Australia.

  • Association of Professional Engineers, Scientists and Managers, Australia (APESMA) Home Page


  • Biospectrum Asia Home Page – Informative website on the pharma/biotech industries in Asia.

  • Australia’s Biotechnology Organisation (Ausbiotech) Home Page – Australia wide biotechnology information website.
  • BioGeelong Home Page – News, links and information on the growing Geelong Biotechnology industry.

Project Management

  • Project Management Institute (PMI) Home Page – Project Management resource website including standards, seminars, education programs and case studies.