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Sunday, May 22, 2011

"Steve Jobs Address to Stanford Students"

Real Innovator for Curiosity,Intuition,Hungry&Foolish.

Watch The Video:

http://youtu.be/UF8uR6Z6KLc
http://www.allaboutstevejobs.com/

'You've got to find what you love,' Jobs says.

This is a prepared text of the Commencement address delivered by Steve Jobs, CEO of Apple Computer and of Pixar Animation Studios, on June 12, 2005.

I am honored to be with you today at your commencement from one of the finest universities in the world. I never graduated from college. Truth be told, this is the closest I've ever gotten to a college graduation. Today I want to tell you three stories from my life. That's it. No big deal. Just three stories.

The first story is about connecting the dots.

I dropped out of Reed College after the first 6 months, but then stayed around as a drop-in for another 18 months or so before I really quit. So why did I drop out?

It started before I was born. My biological mother was a young, unwed college graduate student, and she decided to put me up for adoption. She felt very strongly that I should be adopted by college graduates, so everything was all set for me to be adopted at birth by a lawyer and his wife. Except that when I popped out they decided at the last minute that they really wanted a girl. So my parents, who were on a waiting list, got a call in the middle of the night asking: "We have an unexpected baby boy; do you want him?" They said: "Of course." My biological mother later found out that my mother had never graduated from college and that my father had never graduated from high school. She refused to sign the final adoption papers. She only relented a few months later when my parents promised that I would someday go to college.

And 17 years later I did go to college. But I naively chose a college that was almost as expensive as Stanford, and all of my working-class parents' savings were being spent on my college tuition. After six months, I couldn't see the value in it. I had no idea what I wanted to do with my life and no idea how college was going to help me figure it out. And here I was spending all of the money my parents had saved their entire life. So I decided to drop out and trust that it would all work out OK. It was pretty scary at the time, but looking back it was one of the best decisions I ever made. The minute I dropped out I could stop taking the required classes that didn't interest me, and begin dropping in on the ones that looked interesting.

It wasn't all romantic. I didn't have a dorm room, so I slept on the floor in friends' rooms, I returned coke bottles for the 5¢ deposits to buy food with, and I would walk the 7 miles across town every Sunday night to get one good meal a week at the Hare Krishna temple. I loved it. And much of what I stumbled into by following my curiosity and intuition turned out to be priceless later on. Let me give you one example:

Reed College at that time offered perhaps the best calligraphy instruction in the country. Throughout the campus every poster, every label on every drawer, was beautifully hand calligraphed. Because I had dropped out and didn't have to take the normal classes, I decided to take a calligraphy class to learn how to do this. I learned about serif and san serif typefaces, about varying the amount of space between different letter combinations, about what makes great typography great. It was beautiful, historical, artistically subtle in a way that science can't capture, and I found it fascinating.

None of this had even a hope of any practical application in my life. But ten years later, when we were designing the first Macintosh computer, it all came back to me. And we designed it all into the Mac. It was the first computer with beautiful typography. If I had never dropped in on that single course in college, the Mac would have never had multiple typefaces or proportionally spaced fonts. And since Windows just copied the Mac, it's likely that no personal computer would have them. If I had never dropped out, I would have never dropped in on this calligraphy class, and personal computers might not have the wonderful typography that they do. Of course it was impossible to connect the dots looking forward when I was in college. But it was very, very clear looking backwards ten years later.

Again, you can't connect the dots looking forward; you can only connect them looking backwards. So you have to trust that the dots will somehow connect in your future. You have to trust in something — your gut, destiny, life, karma, whatever. This approach has never let me down, and it has made all the difference in my life.

My second story is about love and loss.

I was lucky — I found what I loved to do early in life. Woz and I started Apple in my parents garage when I was 20. We worked hard, and in 10 years Apple had grown from just the two of us in a garage into a $2 billion company with over 4000 employees. We had just released our finest creation — the Macintosh — a year earlier, and I had just turned 30. And then I got fired. How can you get fired from a company you started? Well, as Apple grew we hired someone who I thought was very talented to run the company with me, and for the first year or so things went well. But then our visions of the future began to diverge and eventually we had a falling out. When we did, our Board of Directors sided with him. So at 30 I was out. And very publicly out. What had been the focus of my entire adult life was gone, and it was devastating.

I really didn't know what to do for a few months. I felt that I had let the previous generation of entrepreneurs down - that I had dropped the baton as it was being passed to me. I met with David Packard and Bob Noyce and tried to apologize for screwing up so badly. I was a very public failure, and I even thought about running away from the valley. But something slowly began to dawn on me — I still loved what I did. The turn of events at Apple had not changed that one bit. I had been rejected, but I was still in love. And so I decided to start over.

I didn't see it then, but it turned out that getting fired from Apple was the best thing that could have ever happened to me. The heaviness of being successful was replaced by the lightness of being a beginner again, less sure about everything. It freed me to enter one of the most creative periods of my life.

During the next five years, I started a company named NeXT, another company named Pixar, and fell in love with an amazing woman who would become my wife. Pixar went on to create the worlds first computer animated feature film, Toy Story, and is now the most successful animation studio in the world. In a remarkable turn of events, Apple bought NeXT, I returned to Apple, and the technology we developed at NeXT is at the heart of Apple's current renaissance. And Laurene and I have a wonderful family together.

I'm pretty sure none of this would have happened if I hadn't been fired from Apple. It was awful tasting medicine, but I guess the patient needed it. Sometimes life hits you in the head with a brick. Don't lose faith. I'm convinced that the only thing that kept me going was that I loved what I did. You've got to find what you love. And that is as true for your work as it is for your lovers. Your work is going to fill a large part of your life, and the only way to be truly satisfied is to do what you believe is great work. And the only way to do great work is to love what you do. If you haven't found it yet, keep looking. Don't settle. As with all matters of the heart, you'll know when you find it. And, like any great relationship, it just gets better and better as the years roll on. So keep looking until you find it. Don't settle.

My third story is about death.

When I was 17, I read a quote that went something like: "If you live each day as if it was your last, someday you'll most certainly be right." It made an impression on me, and since then, for the past 33 years, I have looked in the mirror every morning and asked myself: "If today were the last day of my life, would I want to do what I am about to do today?" And whenever the answer has been "No" for too many days in a row, I know I need to change something.

Remembering that I'll be dead soon is the most important tool I've ever encountered to help me make the big choices in life. Because almost everything — all external expectations, all pride, all fear of embarrassment or failure - these things just fall away in the face of death, leaving only what is truly important. Remembering that you are going to die is the best way I know to avoid the trap of thinking you have something to lose. You are already naked. There is no reason not to follow your heart.

About a year ago I was diagnosed with cancer. I had a scan at 7:30 in the morning, and it clearly showed a tumor on my pancreas. I didn't even know what a pancreas was. The doctors told me this was almost certainly a type of cancer that is incurable, and that I should expect to live no longer than three to six months. My doctor advised me to go home and get my affairs in order, which is doctor's code for prepare to die. It means to try to tell your kids everything you thought you'd have the next 10 years to tell them in just a few months. It means to make sure everything is buttoned up so that it will be as easy as possible for your family. It means to say your goodbyes.

I lived with that diagnosis all day. Later that evening I had a biopsy, where they stuck an endoscope down my throat, through my stomach and into my intestines, put a needle into my pancreas and got a few cells from the tumor. I was sedated, but my wife, who was there, told me that when they viewed the cells under a microscope the doctors started crying because it turned out to be a very rare form of pancreatic cancer that is curable with surgery. I had the surgery and I'm fine now.

This was the closest I've been to facing death, and I hope it's the closest I get for a few more decades. Having lived through it, I can now say this to you with a bit more certainty than when death was a useful but purely intellectual concept:

No one wants to die. Even people who want to go to heaven don't want to die to get there. And yet death is the destination we all share. No one has ever escaped it. And that is as it should be, because Death is very likely the single best invention of Life. It is Life's change agent. It clears out the old to make way for the new. Right now the new is you, but someday not too long from now, you will gradually become the old and be cleared away. Sorry to be so dramatic, but it is quite true.

Your time is limited, so don't waste it living someone else's life. Don't be trapped by dogma — which is living with the results of other people's thinking. Don't let the noise of others' opinions drown out your own inner voice. And most important, have the courage to follow your heart and intuition. They somehow already know what you truly want to become. Everything else is secondary.

When I was young, there was an amazing publication called The Whole Earth Catalog, which was one of the bibles of my generation. It was created by a fellow named Stewart Brand not far from here in Menlo Park, and he brought it to life with his poetic touch. This was in the late 1960's, before personal computers and desktop publishing, so it was all made with typewriters, scissors, and polaroid cameras. It was sort of like Google in paperback form, 35 years before Google came along: it was idealistic, and overflowing with neat tools and great notions.

Stewart and his team put out several issues of The Whole Earth Catalog, and then when it had run its course, they put out a final issue. It was the mid-1970s, and I was your age. On the back cover of their final issue was a photograph of an early morning country road, the kind you might find yourself hitchhiking on if you were so adventurous. Beneath it were the words: "Stay Hungry. Stay Foolish." It was their farewell message as they signed off. Stay Hungry. Stay Foolish. And I have always wished that for myself. And now, as you graduate to begin anew, I wish that for you.

Stay Hungry. Stay Foolish.

Thank you all very much.

Source:stanford.edu

Saturday, May 21, 2011

Tips for Better Life

  1. Take a 10-30 minutes walk every day. And while you walk, smile.
  2. Sit in silence for at least 10 minutes each day.
  3. Sleep for 7 hours.
  4. Live with the 3 E’s — Energy, Enthusiasm, and Empathy.
  5. Play more games.
  6. Read more books than you did the previous year.
  7. Make time to practise meditation, yoga, and prayer. They provide us with daily fuel for our busy lives.
  8. Spend time with people over the age of 70 & under the age of 6.
  9. Dream more while you are awake.
  10. Eat more foods that grow on trees and plants and eat less food that is manufactured in plants.
  11. Drink plenty of water.
  12. Try to make at least three people smile each day.
  13. Don’t waste your precious energy on gossip.
  14. Forget issues of the past. Don’t remind your partner with his/her mistakes of the past. That will ruin your present happiness.
  15. Don’t have negative thoughts or things you cannot control. Instead invest your energy in the positive present moment.
  16. Realise that life is a school and you are here to learn. Problems are simply part of the curriculum that appear and fade away like algebra class but the lessons you learn will last a lifetime.
  17. Eat breakfast like a king, lunch like a prince and dinner like a beggar.
  18. Smile and laugh more.
  19. Life is too short to waste time hating anyone. Don’t hate others.
  20. Don’t take yourself so seriously. No one else does.
  21. You don’t have to win every argument. Agree to disagree.
  22. Make peace with your past so it won’t spoil the present.
  23. Don’t compare your life to others’. You have no idea what their journey is all about. Don’t compare your partner with others.
  24. No one is in charge of your happiness except you.
  25. Forgive everyone for everything.
  26. What other people think of you is none of your business.
  27. GOD heals everything.
  28. However good or bad a situation is, it will change.
  29. Your job won’t take care of you when you are sick. Your friends will. Stay in touch.
  30. Get rid of anything that isn’t useful, beautiful or joyful.
  31. Envy is a waste of time. You already have all you need.
  32. The best is yet to come.
  33. No matter how you feel, get up, dress up and show up.
  34. Do the right thing!
  35. Call your family often.
  36. Your inner most is always happy. So be happy.
  37. Each day give something good to others.
  38. Don’t over do. Keep your limits.
  39. When you awake alive in the morning, thank GOD for it.
  40. Don’t be more calculative in your life for all things.
Source:Pravsworld

Trust God


When God leads you to the edge of the cliff, Trust him fully.

Only one of the two things will happen;
Either he will catch you when you fall or he will teach you how to fly.

Pravs J - Trust God
Source:Pravsworld

Be True to Yourself

Be True to Yourself
Never compromise your values and beliefs,
even it if means risking ridicule and rejection.

Be true to yourself. Live your own life.
And don’t allow others to decide what is best for you.

If you do, you will be unhappy, because, you’re untrue to yourself.

Be True to Yourself

Source:pravsworld

Exercises in Synthetic Organic Chemistry

Exercises in Synthetic Organic Chemistry.
By Chiara Ghiron,&nbspRussell Thomas,

  • Publisher: Oxford University Press, USA
  • Number Of Pages: 144
  • Publication Date: 1997-04-12
  • Sales Rank: 2086113
  • ISBN / ASIN: 0198559437
  • EAN: 9780198559436
  • Binding: Paperback
  • Manufacturer: Oxford University Press, USA
  • Studio: Oxford University Press, USA
  • Average Rating:
  • Total Reviews:



Book Description:

This book is comprised of a series of exercises in synthetic organic chemistry based around recently published syntheses. Each exercise gives a reference to the original work, a synthetic scheme in which either structures or reagents have been omitted, a series of questions on the exercise,
and in most cases references to related literature and useful reviews. The exercises are designed to provide challenges for people with a wide range of backgrounds, from undergraduates to academic staff and industrial group leaders, and they enable readers to increase their vocabulary of synthetic
transformations. Taking a novel approach, this volume encourages active participation; instead of absorbing standard strategies, readers are asked to propose solutions to set problems. The exercises are ideal for group discussions in organic chemistry.

DOWNLOAD LINK:

no password required ifile.it

> archive password: library.nu megaupload.com

> archive password: library.nu mediafire.com

High-Resolution NMR Techniques in Organic Chemistry, Volume 27, Second Edition (Tetrahedron Organic Chemistry)

High-Resolution NMR Techniques in Organic Chemistry, Volume 27, Second Edition (Tetrahedron Organic Chemistry).
By T.D.W. Claridge

  • Publisher: Elsevier Science
  • Number Of Pages: 398
  • Publication Date: 2008-12-29
  • ISBN-10 / ASIN: 0080546285
  • ISBN-13 / EAN: 9780080546285
  • Binding: Hardcover

Product Description:

This book describes the most important high-resolution NMR techniques that find use in the structure elucidation of organic molecules and the investigation of their behavior in solution.

The techniques are presented and explained using pictorial formats wherever possible, limiting the number of mathematical descriptions. The emphasis is on the more recently developed methods of solution-state NMR spectroscopy with a considerable amount of information on implementation and on the setting of critical parameters for anyone wishing to exploit these methods.

* presents a large number of examples to demonstrate the utility of the methods covered

* serves the needs of students and professionals in every chemistry laboratory

* describes the most important methods available, with guidance on execution of experiments.

DOWNLOAD LINK:


ifile.it
> archive password: ebooksclub.org megaupload.com

> archive password: ebooksclub.org fileserve.com

> archive password: ebooksclub.org mediafire.com

High-Resolution NMR Techniques in Organic Chemistry (Tetrahedron Organic Chemistry)

High-Resolution NMR Techniques in Organic Chemistry (Tetrahedron Organic Chemistry).
By T. Claridge
  • Publisher: Pergamon
  • Number Of Pages: 384
  • Publication Date: 1999-12-01
  • ISBN-10 / ASIN: 0080427995
  • ISBN-13 / EAN: 9780080427997
  • Binding: Hardcover



Product Description:

From the initial observation of proton magnetic resonance in water and in paraffin, the discipline of nuclear magnetic resonance has seen unparalleled growth as an analytical method. Modern NMR spectroscopy is a highly developed, yet still evolving, subject which finds application in chemistry, biology, medicine, materials science and geology.

In this book, emphasis is on the more recently developed methods of solution-state NMR applicable to chemical research, which are chosen for their wide applicability and robustness. These have, in many cases, already become established techniques in NMR laboratories, in both academic and industrial establishments. A considerable amount of information and guidance is given on the implementation and execution of the techniques described in this book.


Summary: Quality book, but can't compete with the original
Rating: 4

Just a bit of material to supplement the earlier review... This is a very solid book for advanced users of NMR spectroscopy investigating organic compounds. However, if you can get your hands on it, Derome's "Modern NMR Techniques for Chemistry Research" is better written and clearer to understand. Unfortunately, that book has been out of print for some time and is now hard to find. That said, Claridge's book represents and extra decade's worth of material and you really can't go wrong with either book.



Summary: successor to classic
Rating: 5

Many people have been waiting for the publication of this book. As the successor of one of the most beloved classic NMR texts "Modern Nmr Techniques for Chemistry Research - by A.E.Derome, 1987" it is nicely updated and still nice looking and easy to understand.

For those who want to get some insights on the NMR experiment, it would be a great help. This seems to target organic chemists who use NMR everyday and eager to know what is going on inside, but even serious NMR research may want to see this book. This book includes more recent technique and discussion on the solution NMR, and also some of bried overview on the solid state NMR. Easy to follow explanation, more intuitive and pictorial description would be very helpful to the chemistry student and researchers.

DOWNLOAD LINK:

ifile.it

Tuesday, May 17, 2011

How To Succeed At Work And In Career(Source:pravsworld)

How To Succeed At Work And In Career.

1. Don’t talk negatively about people behind their backs. If you gossip, people won’t confide in you. Mind your own business.

2. Try to work for someone who’ll challenge your powers.You’ll learn more in a year than 4 years of college.

3. Successful bosses have good communication skills. They learn from people, including their employees.

4. Work in such a way that makes your boss look good. It’s not flattery.

5. On downsizing, the first to go are those with few friends. Bosses prefer competent people whom they respect.

6. Dress for the job you want, not the one you have. Let your dress reflect professionalism.

7. Workout to get in good physical shape. Unless exceptionally skilled, the unhealthy are at a comparative disadvantage.

8. Personal integrity is crucial. Tell nothing but the truth. Bosses can forgive mistakes but if you lie, you’re gone.

9. Be on time. Try to arrive few minutes early. It saves you from stress. You’ll be much relaxed & work better.
10. Strive your best to keep a deadline. If you cannot meet it, then apologize & ask for an extension

11. Don’t take things personally. If some people are unhappy with you, it’s their problem. But always strive to give your best.

12. If you must correct someone, don’t get personal about it. Do it never in front of others.

13. Spend some time alone everyday. What’s the mission of my life? What do I want to be? And how to go about it.

14. As you move along Plan A of your career, maintain a Plan B as well — an alternative course to rely

15. Always remember that the secret of success is passion. Always think big. Spread love & joy. You’ll have blissful years ahead.

work is a rubber ball(Source:pravsworld)


Balance Your Life

Imagine life as a game in which you are juggling some 5 balls in the air. You name them - work, family, health, friends and spirit. And you are keeping all of these in the air.


You will soon understand that work is a rubber ball. If you drop it, it will bounce back.

But the other four balls - family, friends, health and spirit are made of glass. If you drop one of these, they will be irrevocably scuffed or damaged or even shattered. They will be never the same. You must understand that and strive for balance in your life.

Tuesday, May 10, 2011

The Vocabulary and Concepts of Organic Chemistry, 2nd Edition

The Vocabulary and Concepts of Organic Chemistry, 2nd Edition.
912 Pages | John Wiley & Sons Canada, Ltd. | May 20 2005) | ISBN: 0471680281 | PDF | 6,3 MB

Book Description
This book is a basic reference providing concise, accurate definitions of the key terms and concepts of organic chemistry. Not simply a listing of organic compounds, structures, and nomenclatures, the book is organized into topical chapters in which related terms and concepts appear in close proximity to one another, giving context to the information and helping to make fine distinctions more understandable. Areas covered include: bonding, symmetry, stereochemistry, types of organic compounds, reactions, mechansims, spectroscopy, and photochemistry.

From the Back Cover
Concise, accurate, in-depth definitions of all key terms and concepts in organic chemistry

The language of organic chemistry embodies a unique set of concepts and nuanced meanings. For more than a quarter of a century, students and professionals seeking to acquire a quick and thorough familiarity with that language have turned to The Vocabulary of Organic Chemistry.

No mere alphabetical listing, this one-of-a-kind reference comprises eighteen topical chapters covering key subject areas in organic chemistry and related fields—from atomic orbital theory to polymer chemistry, nuclear magnetic resonance spectroscopy to the chemical utilization of fossil fuels. Related terms and concepts—such as catalyst and zoelite—appear in the same chapter and in close proximity to one another, thus placing them in context and making it easier for readers to grasp fine distinctions. And throughout, specific examples and clearly drawn structures help to clarify key concepts.

Revised and updated for the twenty-first century, The Vocabulary and Concepts of Organic Chemistry, Second Edition offers:
Hundreds of terms and concepts—fully explained and in context
Myriad examples and illustrations
Brief introductory narratives that help place subject areas in historical perspective
New sections on the four common spectroscopies (NMR, IR, Mass, UV) and photochemistry

Written by an author team with nearly one and a half centuries of combined teaching and research experience, this book is an ideal study aid for undergraduate and graduate students and a valuable professional resource for chemists who want to brush up on specific areas in organic chemistry.

DOWNLOAD LINK:
Download

Fundamentals of Environmental Chemistry, Second Edition by Stanley E. Manahan

Fundamentals of Environmental Chemistry, Second Edition by Stanley E. Manahan.
Publisher: CRC Press; 2 edition (July 31, 2000) | ISBN: 156670491X | Pages: 1024 | PDF | 5.36 MB

Written by a leader in the field, the Fundamentals of Environmental Chemistry, Second Edition puts the fundamentals of chemistry and environmental chemistry right at your students fingertips. Manahan presents the material in an understandable and interesting manner without being overly simplistic.They get basic coverage on:-Matter and the basis of its physical nature and behavior-Organic and biological chemistry-Chemistry of water, soil, and air-Industrial chemistry-Toxicological chemistry as it pertains to occupational health and human exposure to pollutants and toxicants-Energy, nuclear energy, and nuclear waste-Applications of nuclear science in areas such as tracing pesticide degradation and nuclear medicine - More than an introduction to this field, Fundamentals of Environmental Chemistry, Second Edition provides the foundation that gives your students an understanding of the chemical processes of the environment and the effects pollution on those processes.

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The Organic Chemistry of Sugars by Daniel E. Levy (Repost)

The Organic Chemistry of Sugars by Daniel E. Levy (Repost).
Publisher: CRC Press; 1 edition (September 21, 2005) | ISBN: 0824753550 | Pages: 904 | PDF | 27.59 MB

Intrigued as much by its complex nature as by its outsider status in traditional organic chemistry, the editors of The Organic Chemistry of Sugars compile a groundbreaking resource in carbohydrate chemistry that illustrates the ease at which sugars can be manipulated in a variety of organic reactions. Each chapter contains numerous examples demonstrating the methods and strategies that apply mainstream organic chemistry to the chemical modification of sugars. The book first describes the discovery, development, and impact of carbohydrates, followed by a discussion of protecting group strategies, glycosylation techniques, and oligosaccharide syntheses. Several chapters focus on reactions that convert sugars and carbohydrates to non-carbohydrate molecules including the substitution of sugar hydroxyl groups to new groups of synthetic or biological interest, cyclitols and carbasugars, as well as endocyclic heteroatom substitutions. Subsequent chapters demonstrate the use of sugars in chiral catalysis, their roles as convenient starting materials for complex syntheses involving multiple stereogenic centers, and syntheses for monosaccharides. The final chapters focus on new and emerging technologies, including approaches to combinatorial carbohydrate chemistry, the biological importance and chemical synthesis of glycopeptides, and the medicinally significant concept of glycomimetics. Presenting the organic chemistry of sugars as a solution to many complex synthetic challenges, The Organic Chemistry of Sugars provides a comprehensive treatment of the manipulation of sugars and their importance in mainstream organic chemistry.


Chirality in Transition Metal Chemistry. Molecules, Supramolecular Assemblies and Materials by Hani Amouri (Repost)

Chirality in Transition Metal Chemistry. Molecules, Supramolecular Assemblies and Materials by Hani Amouri (Repost).
Publisher: Wiley (December 31, 2008) | ISBN: 0470060530 | Pages: 260 | PDF | 19.62 MB

Chirality in Transition Metal Chemistry is the latest addition to the Wiley Inorganic Chemistry Advanced Textbook series. This series reflects the pivotal role of modern inorganic and physical chemistry in a whole range of emerging areas such as materials chemistry, green chemistry and bioinorganic chemistry, as well as providing a solid grounding in established areas such as solid state chemistry, coordination chemistry, main group chemistry and physical inorganic chemistry.



Friday, May 6, 2011

GMP Regulations/Guidelines - International Countries

ICH Q6A Guide

Good Clinical Practice

May 1996

Q6A: Specifications:

Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances

December 2000

ICH Q7A Guide for Industry

Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

December 2000

Q8 Guide

Pharmaceutical Development

Q9 Guide

Quality Risk Management

Q10 Guide

Pharmaceutical Quality Systems

May 2007 (draft)

Europe

EU GMP Directive

The rules governing medicinal products in the European Union

Volume 4, Good manufacturing practices

Medicinal products for human and veterinary use

To view and download the individual chapters and annexes

http://ec.europa.eu/health/documents/eudralex/vol-4/index_en.htm

Annex 11 of EU GMP

Computerized Systems

Requirements are somewhat similar as 21 CFR part 11

Annex 15 of EU GMP

Validation and Qualification

Master plan, DQ, IQ, OQ, PQ, Equipment and Processes

European Pharmacopoeia

Distributed through EDQM

(European Directorate for the Quality of Medicines and Healthcare)

European Medicines Agency (EMEA)

Procedure for Coordinating Preauthorization GMP and Product/Process Related Inspections

European Medicines Agency (EMEA)

Note for Guidance for Start of Shelf Life of the Finished Dosage Form

Annex to Note for Guidance for Manufacture of the Finished Dosage Form

EU Directive 2001/20/EC

Good Clinical Practice

On the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use

EU Directive 2001/83/EC

On the Community Code Relating to Medicinal Products for Human Use

World Health Organization

Good Manufacturing Practices for pharmaceutical products: main principles
(TRS 908, Annex 4)

Active pharmaceutical ingredients (bulk drug substances)

Sterile pharmaceutical products (TRS 902, Annex 6)

Inspections of pharmaceutical manufacturers (TRS 902, Annex 7)

Quality system requirements for national GMP inspectorates (TRS 902, Annex 8)

Guidance on GMP inspection (TRS 908, Annex 6)

Model Certificate of GMP (TRS 908, Annex 5)

Final Draft: Good manufacturing practices: Updated supplementary guidelines for the manufacture of herbal medicines.

Validation of analytical procedures use in the examination of pharmaceutical materials (TRS 823, Annex 5)

Provisional guidelines on the inspection of pharmaceutical manufacturers (TRS 823, Annex 2)

GMP Question and Answers

Good Distribution Practices for Pharmaceutical Products (draft)

A Guide to Good Manufacturing Practice (GMP) Requirements. Part 1: Standard operating procedures and master formulae

WHO pharmaceutical starting materials certification scheme (SMACS): guidelines on implementation

WHO Expert Committee on Specifications for Pharmaceutical Preparations

PIC/S - Pharmaceutical Convention Inspection Scheme

Pharmaceutical Inspection Convention Scheme (PICS) Publications

GMP, API, Master Plan, Computerized Systems

Click on Publications

Guide to Good Manufacturing Practice for Medicinal Products

PIC/S GMP Guide for Validation of Aseptic Processes

Recommendation on Quality System Requirements for Pharmaceutical Inspectorates

PIC/S Guidance on Good Practices for Computerised Systems in Regulated "GXP" Environments

Aide Memoire on Inspection of Quality Control Laboratories

Aide Memoire on Inspection of Biotechnology Manufacturers

Aide Memoire on Inspection of APIs

Australia

Australian Code of Good Manufacturing Practice for Medicinal Products

Based on PICS, August 2002

Questions & answers on the Australian code of good manufacturing practice for medicinal products

Canada

Guidelines for Cleaning Validation

U.S. FDA - United States Food and Drug Administration

FDA Regulations

21 CFR Part xxx

WHO good manufacturing practices

WHO good manufacturing practices.

Risk analysis

Training materials

Newly Added Guidance Documents

Below is a sortable list of the most recently added Guidance Documents.

You can sort alphabetically by: Category/Subject Area; Guidance Title; Guidance Type (Draft or Final) and also sort by the Date the Guidance was issued.

Newly Added Guidance Documents

Guidance Documents will be retained in this section of the page for a period of three months. The most recently added appears first and they are in the order of the date they were issued.