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TOP 5 GMP Downloads

1. Quality Agreement
Defines framework conditions and processes between contract givers and contract acceptors in order to meet mandatory quality criteria.

 

2. GDP Audit Checklist
More than 700 questions with reference to regulations for preparing and carrying out GDP audits.

 

3. GMP Audit Checklist
The GMP Audit Checklist works great for both sides - the auditor and the inspected company.

 

4. Technical Agreement
and Delimination of Pharmaceutical Responsibilities.

 

5. A Process Approach to Pharmaceutical Quality Systems
A Guide to ICH Q10 Compliance

 

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Experts

You need GMP information that is reviewed by GMP experts and is guaranteed reliable. Our advisory board includes members from US, Europe and Japan. They supervise the content and development of the GMP MANUAL. More than 50 experts around the world write articles that are peer-reviewed. You get the best GMP information when you need it.

Our panel has the right background and credentials to make sure that we provide the highest level of expertise and knowledge to the industry:

 

Author

1983–1987 Study of pharmacy, University of Muenster

1988–1990 Practical Pharmaceutical Education, National Military Service as Pharmacist/Officer for the medical military service

1990–1993 Ph.D. in Pharmaceutical Technology, University of Muenster

1994–1998 Bayer AG Leverkusen, Formulation Development Pharmaceutical Technology:

International development and scale-up of controlled release delivery systems. Project management for purchase and installation of explosion-protected organic solvent equipment (film coater, vacuum tray dryer).

1998–2000 Bayer AG, International Project Management:

Global Project Management of brands (ADALAT and CIPROBAY). Development and launch of „Line-extensions“ (Adalat GITS 20mg, Cipro i.v. flexibags, Cipro OT, Cipro od Tbl.). Interface with international cooperation partners and licensees (Pfizer/New York, Alcon/Fort Worth, Abbott/Chicago, Ranbaxy/New Delhi, Alza/Palo Alto). Re-organisation of Medical Development, optimization of budgeting system.

2001–2005 Implanta AG, Development, Production, Quality Management:

Setup and implementation of a Quality Management System conforming to ISO 13485 and MDD 93/42; Development Polymer-Stent, Implementation of production unit including “aseptical” manufacturing, controlling and acquisition of capital funds.

2003–2007 Sepaserve GmbH, Founder and Shareholder:

Development of Micro-Capillary Liquid Chromatograph, Development of chiral stationary Polysaccharid Phases (CSPs). Trade sale to Phenomenex/USA

2005–2008 Freelancer as Consultant and Auditor:

Auditing and Consulting QMS (ISO 9001, 13485, 15378, EU GMP Part I & Part II), Auditing/Conformity Assessment Procedures for non-active medical devices acc. to MDD 93/42, free-lance auditor for EU notified body, consultancy/project management for medical device, pharmaceutical and packaging material companies.

since 2007 blue inspection body GmbH, Founder, Managing Director and Shareholder:

Accredited Inspection Body for “Third-Party“ GMP-Audits with a focus on Excipients and Active Pharmaceutical Ingredients (APIs). Global auditing of manufacturers.

since 2006 Presentations and Publications related to the topics “Pharmaceutical packaging materials: Ready-to-use- Glass Syringes“ and “GMP compliance/Auditing“ with a focus on “APIs and Excipients“

Publications at Maas & Peither GMP Publishing:
  • GMP MANUAL
    (Author of chapter 21.C Marketing authorisation documentation for active substances, 21.D GMP Certificates, 21.E Auditing active substance manufacturers, 21.F Chemical active substances)