No. 7 - Contract Manufacturing

Back to Basics - Contract Manufacturing

by Dr. Gero Beckmann

A brief summary of contract manufacturing cGMP requirements is provided, including a description for a contract which can be tailored to your own requirements, whether you are a Contract Giver or a Contract Acceptor in the pharmaceutical industry.

Back to Basics - Contract Manufacturing

This article is an excerpt of the gmp review, a publication of our UK Partner Euromed Communication Ltd.

GMP Calendar 2010

Are you familiar with our popular GMP calendar yet?

It is a great give away to your colleagues, customers or for yourself. It has 250 new GMP related questions and answers from a wide variety of GMP areas, for example: Qualification, Validation, Inspections, Quality Assurance, Packaging, Training, Hygiene, Documentation, etc.

GMP for every day - GMP Calendar 2010

370 Pages, Format: 150 x 135 mm
€ 11.90/USD 20.00 + tax & shipping

GMP Audit Checklist

Not only contract manufacturers have to be audited. Self inspection audit, supplier audits, API manufacturer and more inspections must be done on a regular basis by the pharmaceutical industry. Take a look at a few pages of our comprehensive audit checkliste from the GMP MANUAL. The complete checklist covers more than 500 questions for every GMP aspect with references to the US and EU regulations.

Audit Checklist (reading sample)

More information: GMP MANUAL

GMP MANUAL Volume 1 Manufacturing

The brand new and up-to-date practice book MANUFACTURING is now available.

It supports staff in the pharmaceutical production field by providing internationally accepted GMP guidance. In this book, international GMP experts share their knowledge of GMP implementation according to GMP regulations of the FDA, Europe, ICH, PIC/S and WHO. You’ll learn how noted industry specialists solve the quality challenges in their companies. Improve and fine-tune your procedures accordingly. You will receive answers to quality related questions that affect your daily business.

Chapters: Production, Packaging, Laboratory and Analytical Control, Documentation. This is an excerpt from the comprehensive reference work GMP MANUAL.

620 pages, € 175 / US$ 250

More information: Volume 1 Manufacturing

Latest GMP News

The EU revises regulation on outsourcing fo GMP activities. The GMP/GDP Inspectors Working Group proposes with the published document a revision of Chapter 7 "Contract Manufacture and Analysis" of the EU GMP Guide in order to upgrade guidance of outsourced GMP activities.

Read more about this interesting paper in our news-area:

Outsourcing GMP Activities

FDA extended the comment period for the new 21 CFR Part 4 on combination products. Read all the details with one click:

Combination Products 21 CFR 4

find more news in our regularily updated: NEWSAREA

Season's Greetings

The Maas & Peither team would like to thank you for your continuous patronage. At this point we would like to especially thank the numerous partners and authors which are supporting us to keep our products up to the highest standards - so that our clients have the latest information at hand. We could not do this without you!

Season's Greetings and a prosperous New Year

Your Maas & Peither Team