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Saturday, August 31, 2013


Hold fast to dreams for if dreams die, life is a broken winged bird that cannot fly....Inspirational Quotes by Langston Hughes
"Reach high, for stars lie hidden in your soul. Dream deep, for every dream precedes the goal."....Inspirational Quotes by (Unknown)
"where the willlingness is great, the difficulties cannot be great"
"I know it seems hard sometimes, but remember one thing, through every dark night, there's a bright day after that. So no matter how hard it gets, keep your chest out, keep your head up and handle it."....Inspirational Quotes by Tupac

"Start writing a new chapter, for if you live by the book you'll never make history."....Inspirational Quotes by (Ben Sobel)
"Wheresoever you go, go with all your heart."....Inspirational Quotes by (Confucius)
"I have not failed. I've just found 10,000 ways that won't work."....Inspirational Quotes by (Thomas Alva Edison)
"If you don't run your own life, somebody else will."....Inspirational Quotes by (John Atkinson)
"Get busy living, or get busy dying."....Inspirational Quotes by (Stephen King, The Shawshank Redemption)
"The important thing is to not stop questioning. "....Inspirational Quotes by (Albert Einstein)
Never look down on anybody unless you’re helping him up....Inspirational Quotes by (The Reverend Jesse Jackson)
Practice random acts of kindness and senseless acts of beauty....Inspirational Quotes by Adair Lara.

Yes, I do touch. I believe that everyone needs that....Inspirational Quotes by (Princess of Wales Diana).
Enjoy the little things in life, for one day you may look back and realize they were the big things....Inspirational Quotes by (Antonio Smith).
"Failure is taking the path that everyone else does, success is making your own path."....Inspirational Quote by (Unknown).
"Success is determined by how determined you are to succeed."....Inspirational Quotes by Unknown.
"The things you fear are undefeatable, not by their nature, but by your approach."....Inspirational Quote by Jewel.
"Twenty years from now, you will be more disappointed by the things you did not do than by the things you did do. So, throw off the bowlines. Sail away from the safe harbor. Catch the trade winds in your sails. Explore. Dream. Discover."....Inspirational Quotes by Mark Twain.
It is by nature to hate those you injure....Inspirational Quotes by unknown.
Nothing is but what is not....Inspirational Quote by shakespear.
The world is not thy friend nor the worlds law....Inspirational Quotes by shakespear.
When you chose not to decide you have already made a choice!....Inspirational Quotes by Unknown.
"Confidence comes not from always being right, but from not fearing to be wrong."
Whatever is to be will be!....Inspirational Quotes by Anon)
You create your own destiny....by Anon

Happiness is not a destination in which you arrive, it is your journey there.
"If you haven't all the things you want, be grateful for the things you don't have that you wouldn't want."....Inspirational Quotes by Anonymous.
"People are lonely because they build walls instead of bridges."....Inspirational Quotes by Unknown.
Work like you don't need the money, Love like you've never been hurt, And dance like no-one's watching....Inspirational Quotes by Anonymous.
"Never give in, never give in, never, never, never, never in nothing, great or small, large or petty, never give in except to convictions of honor and good sense."....Inspirational Quotes by Churchill.
"A pessimist sees the difficulty in every opportunity; an optimist sees the opportunity in every difficulty."....Inspirational Quotes by Churchill.
"I like living. I have sometimes been wildly, despairingly, acutely miserable, racked with sorrow, but through it all I still know quite certainly that just to be alive is a grand thing."....Inspirational Quotes by Agatha Christie.
Everyone is necessarily the hero of his own life story....Inspirational Quotes by John Barth.
A hero is no braver than an ordinary man, but he is braver five minutes longer....Inspirational Quote by Ralph Waldo Emerson.
"If you haven't got all the things you want, be grateful for the things you don't have that you don't want."....Inspirational Quotes by Anonymous.
"Throw your dreams into space like a kite, and you do not know what it will bring back, a new life, a new friend, a new love, or a new country."....Inspirational Quotes by Anais Nin.
"An error can never become true however many times you repeat it. The truth can never be wrong, even if no one hears it."....Inspirational Quotes by Mahatma Gandhi.
"Cherish your wishes and your dreams, as they are the children of your soul and the blueprints of your ultimate achievement."....Inspirational Quotes by Unknown.
"Things today may not be great, but they are not bad, and that's good."
The only thing in life achieved without effort is failure....Inspirational Quotes by Unknown.
Like the light in the dark of dismal night,Let your self stand out as glowing, warm, and welcome....Inspirational Quotes Quote by Validivar.
It's easy to make a buck. It's a lot tougher to make a difference....Inspirational Quotes by Tom Brokaw.
Don't judge those who try and fail, judge those who fail to try....Inspirational Quotes by Unknown.
When the power of love overcomes the love of power the world will know peace....Inspirational Quotes by Unknown.
In three words I can sum up everything I've learned about life-it goes on....Inspirational Quotes by Robert Frost.
One who makes no mistakes never makes anything....Inspirational Quotes by Unknown.
The journey of a thousand miles begins with one step....Inspirational Quotes by Miyamoto Musashi. 
Anyone can hold the helm when the sea is calm....Inspirational Quotes by Unknown.
Come to the edge....We can't, we are afraid....Come to the edge....We can't, we will fall ....And they came to the edge....And he pushed them....And they flew....Inspirational Quotes by Appolinaire.
"Conquering any difficulty always gives one a secret joy, for it means pushing back a boundary-line and adding to one's liberty."....Inspirational Quotes by Henri Frederic Amiel.
"Never be bullied into silence. Never allow yourself to be made a victim. Accept no one's definition of your life; define yourself."....Inspirational Quotes by Harvey Fierstein.
"How can you be free from fears? Fear no one, but love every man that you see. We are living in fear because our mind holds negative thoughts about people. Are you afraid of your loved ones?"....Inspirational Quotes by Ty Luu.
To ourselves, we are great. Yet most of us live life without making a stand, contented to blend into the background of self-rendering nothingness, and when looking back feel contented at our mediocre accomplishments. Nobody remembers the person who conformed out of inadequacy. Nobody notices a patch of grass, they see the tree....Inspirational Quotes by Wayne Burrow, Philosopher.
"The world is so fast that there are days when the person who says it can't be done is interrupted by the person who is doing it." ....Inspirational Quotes by Anon.
"Government of the people, by the people, for the people, shall not perish from the Earth."....Inspirational Quotes by Abraham Lincon.
"There are many ways of going forward, but only one way of standing still."....Inspirational Quote by Franklin D. Roosevelt.
"Most of the important things in the world have been accomplished by people who have kept on trying when there seemed to be no hope at all."....Inspirational Quotes by Dale Carnegie.

Wednesday, August 28, 2013

Online Training module

Here below a few of training module is presented on GMP.

Training Module

FDA publishes guidance document on capillary Electrophoresis
The ICH Steering Committee recommends that the analytical procedures described in the official pharmacopoeial texts, Ph. Eur. 2.2.47. Capillary Electrophoresis, JP General Information. Capillary Electrophoresis, and USP General Information Chapter <1053> Biotechnology-derived Articles – Capillary Electrophoresis,  can be used as interchangeable in the ICH regions. To view the guidance, CE FDA Guidance

Uncertainty of Measurement-Part 2: OMCL Policy on the Estimation and Application of Uncertainty in Analytical Measurement

To get the copy of Analytical instrument qualification from Agilent technologies click the link  - Analytical Instrument Qualification

Guidance for UK Manufacturer’s Licence and Manufacturer’s Authorisation (for Investigational Medicinal Products) Holders on the use of UK Stand Alone Contract Laboratories
This document:
• Defines a stand alone contract laboratory in relation to quality control testing of medicinal products.
• Provides guidance as to when a contract laboratory must be named on a manufacturer’s licence for relevant medicinal products for human and veterinary use and/or a manufacturer’s authorisation for investigational medicinal products.
• Is applicable to all manufacturing licence holders, i.e. import, export, herbals and specials.
• Provides guidance as to when a contract laboratory is not required to be named on a manufacturer’s licence or authorisation.
• Outlines the MHRA’s criteria for inspection of contract laboratories.
This guidance can be downloaded by clicking Guidance .

Analytical Balance

HPLC Column comparison
To find out alternative column for your column of interest.
HPLC Troubleshooting guide

Instrument calibration
1. Disolution Apparatus 1 & 2 - Mechanical calibration
Calibration of Dissolution Apparatus 1&2
Recently FDA has released a new guidance on Calibration of disolution apparatus 1 & 2. This guidance document more emphasis on enhanced mechanical calibration than chemical performance verification test. This guidance also recommends to manufacturer take appropriate control to handle recognised source of significant variablity during dissolution testing like dissolved gases, vibration and vessel dimensions. For more information go through the link .Guidance to industry -Dissolution

                        Dissolution procedure toolkit
USP released the version 2 of dissolution tool kit procedure for mechanical calibration and performance verification test apparatus 1 & 2. The dissolution toolkit provides a description of best practices associated with the mechanical calibration and performance verification test for the USP basket and paddle dissolution apparatuses and test assemblies.This second version of the dissolution toolkit represents a continuing effort to provide detailed information describing the procedures that if used will assure a properly qualified dissolution test assembly. For more information click Disolution Toolkit Procedure Version-2.
To refer version-1 click Dissolution Toolkit version-1
Further USP established a new acceptance criteria for current lot of Prednisone tablet. For more information click the link Performance of Equipment to Test Dissolution of Medications Further Assured
2. Prednisone tablet for PVT - New lot - P1I303
Prednisone Tablet for PVT - A new lot is released on March 01, 2010 Lot No.P1I300 valid through Feb 29, 2012 with test procedure an optional two stage test and calculation example. On April 30, 2010, Lot P0E203 will no longer be official.
Note: There was an error in the initial USP certificate dated Feb.22, 2010. It is now corrected. For corrected certificate click Prednisone Tablet for PVT - New lot released on March 2010.

Instrument Qualification

Result & Reports

Ph. Eur. / USP Prospective Harmonization — API Pilot Project: Industry Perspective  
ISO 17025 New
Elemental Impurities—Comments and Responses 
Flow Microscopy—Dynamic Image Analysis for Particle Counting 
A Recombinant Factor C Procedure for the Detection of Gram-negative Bacterial Endotoxin

21 CFR Part 11

New EU GMP Guide Annex 11 "Computerised Systems"  & Chapter 4 "Documentation" 

In Europe the EU GMP Guide Annex 11 "Computerised Systems" is the regulatory basis for GMP regarding IT systems in the pharmaceutical industry. The new version was issued on 3 January 2011 together with the EU GMP Guide Chapter 4 "Documentation". It will become effective on 30 June 2011.
Reasons for changes: the Annex has been revised in response to the increased use of computerised systems and the increased complexity of these systems. Consequential amendments are also proposed for Chapter 4 of the GMP Guide.
Deadline for coming into operation: 30 June 2011

Reasons for changes: the sections on "generation and control of documentation" and "retention of documents" have been revised, in the light of the increasing use of electronic documents within the GMP environment.
Deadline for coming into operation: 30 June 2011

The PIC/S Guide to Good Manufacturing Practices is the basis for GMP inspections. In particular its Annex 11, ‘Computerised Systems’ is used when inspecting such systems. 

Guidance document on part 11-Electronic signature & Electronic record & Computer System Validation(CSV)
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

Encyclopedic Dictionary of Named Processes in Chemical Technology

Book cover Encyclopedic Dictionary of Named Processes in Chemical Technology

This reference provides concise descriptions of those chemical processes that are known by special names which are not obvious or self-explanatory. Containing 2,600 entries, this second edition includes information on the many new processes developed and commercialized, as well as new information on old processes.Encyclopedic Dictionary of Named Processes in Chemical Technology presents a heterogeneous collection of names- inventors, companies, institutions, places, acronyms, abbreviations, and obvious corruptions-of the chemical nomenclature. The author has tailored the entries to reflect importance and topicality. Generally, the processes in current use have the longest entries, however, he also devotes more space to some obsolete processes that hold particular technical interest or historical significance.The appendix is an index to product names, enabling readers to identify processes used for making particular products.  

Year: 1999
Edition: 2
Language: English
Pages: 312

DOE Handbook Chemical process hazards analysis

Book cover DOE Handbook Chemical process hazards analysis

Year: 1996
Language: English
Pages: 93

Encyclopedia of chemical processing (5 vols.)

Book cover Encyclopedia of chemical processing (5 vols.)

Coverage in this reference extends from fundamental aspects of industrial catalytic processes to polymerization processes. More than 400 entries delve in to synthetic reactions, catalyst and reactor choice, process simulation, energy integration, pinch design and more. The text details emerging technologies such as plasma polymerization and supercritical fluid technology.

Year: 2005
Edition: 2
Language: English
Pages: 3338

Pharmaceutical Process Chemistry for Synthesis: Rethinking the Routes to Scale-Up

Year: 2011
Edition: 1
Language: English
Pages: 377

The Art of Process Chemistry

Book cover The Art of Process Chemistry
Providing must-have knowledge for the pharmaceutical industry and process chemists in industry, this ready reference offers solutions for saving time and money and supplying -- in a sustainable way -- valuable products. Application-oriented and well structured, each chapter presents successful strategies for the latest modern drugs, showing how to provide very fast bulk quantities of drug candidates. Throughout, the text illustrates how all the key factors are interwoven and dependent on one another in creating optimized methods for optimal products.
Year: 2010
Edition: 1
Language: English
Pages: 298