GMP Summer Special 30%

Equipment Qualification Part IV

There are topics in the field of equipment qualification that are often a point of discussion: Documentation - Qualification of established facilities - Requalification

The EU GMP Guideline states in Annex 15, Sec. 45:
"Where no significant changes have been made to the validated status, a review with evidence that facilities, systems, equipment and processes meet the prescribed requirements fulfils the need for revalidation"

Read in the last part of the qualification series what regulators say about these requirements.

Equipment Qualification - Documentation - Qualification of Established Facilities - Requalification (part IV)

Did you miss the 1st,  2nd or 3rd part?

Equipment Qualification - Legal Requirement (part I)

Equipment Qualification - DQ and IQ (part II)

Equipment Qualification - OQ and PQ (Part III)

SUMMER SPECIAL 30%

Until August 31, 2010, we offer you a special summer discount of 30% for selected products from our GMP MANUAL series. Save up to € 200 or $ 298:

• GMP MANUAL Online Named User Licence
• GMP MANUAL Hardcopy incl. CD-ROM
• GMP MANUAL CD-ROM only
• GMP MANUAL Volume 1 Manufacturing
• GMP MANUAL Volume 2 Validation Procedures

What customers say about the GMP knowledge source GMP MANUAL:

“This is an excellent reference work. It covers nearly all the important topics within GMP and has the flexibility to grow over time. All subjects are dealt with logically and in great detail. The use of checklists, examples and hyperlinks to related topics are particularly good. […] this is an excellent investment for both practitioners and trainers. I will certainly be using it extensively.” Dr. Kate E. McCormick, UK

Knowledge is power: Take the chance and order today your personal copy of the GMP knowledge base GMP MANUAL.
Order now at the Maas & Peither bookshop!

10 Reasons to order the GMP MANUAL today!

GMP News

Recently the regulators published some interesting documents. Find here the links to our up-to-date GMP news on our website:

Europe

• EU GMP Guide part II comes into operation
• EU GMP Guide Annex 6 & 13 comes into operation
• EMA: Pilot Batch Size - Process Control
• EMA: Biopharmaceutical and Bioanalytical Data
• EDQM: Pharm. Eu 7th Edition

USA

• FDA: Draft Guidance Devices
• FDA: Q8, Q9, Q10 Questions & Answers

NEW PUBLICATIONS

Two new GMP Pocket Guides are available now:

GMP Pocket Guide #3:

GMP Glossary and Abbreviations
You find in this handy booklet 500 GMP definitions and 700 abbreviations of GMP terms. More information...

GMP Pocket Guide #4:

ICH Q8, Q9 and Q10
These  very important regulations of the ICH (International conference on harmonisation of  technical requirements for registration of pharmaceuticals for human use) are now together in one booklet. More information...

These booklets are appropriate to have the most important regulations at your fingertips. They are also great giveaways for your clients and staff. Special corporate editions are available - please ask for a quote.

Order now at the Maas & Peither internet shop.

Technology Transfer

This book serves as a comprehensive overview and guide to the technology transfer process for pharmaceutical drug substance and products and the corresponding analytical methods and tests from R&D to production. Each of the contributors has extensive personal knowledge and experience in this field and each has provided practical examples to explain the critical factors involved in achieving successful and effective technology transfers.

This book will benefit practitioners working in the pharmaceutical science and related industries from R&D, commercial production to project management, clinical, regulatory affairs and quality assurance.

More information and order here ...

PDA Parenterals Conference 2010 in Berlin

From 26-28 October, 2010 the PDA Parenterals Conference will be held in Berlin. This outstanding event will cover the very important topics:

• Future of Parenterals
• Packaging and Impact on Quality
• Manufacturing Flexibility and Control
• Innovative Plants
• Monitoring Technologies
• Medical and Application Devices
• Regulatory Trends

Don´t miss this interesting conference in Berlin, Germany.

Brochure of PDA Parenterals Conference 2010, October 26-28