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Maas & Peither AG
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Phone +49 (0)7622 666 86-70
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King of Prussia, PA 19406, USA

Phone +1 (610) 768-8028
Fax     +1 (610) 337-9548


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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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.

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1991–1998 Study of Geology / Goethe-University Frankfurt/Main; Germany1992–2000 Fresenius AG, GMP-Referate / Quality Assurance:
SOP-Management, pharmaceutical-technical qualification and key accounting of external and internal contract manufacturers,

2000–2007 Pharmaplan GmbH, NNE-Pharmaplan GmbH:
Executive Project Engineer: Quality Management- and GMP-Compliance-Consulting for Pharmaceuticals & Medical Devices, Project Management, Process Optimisation (Process Logistics, Process Technology), accompanying Inspections by competent authorities, GMP-Audits of manufacturing sites: Pharmaceuticals, Active Pharmaceutical Ingredients, Medical Devices, Planning & Execution of GMP-Training programs, Feasibility Studies, Qualification- & Validation projects, Design-Reviews, Planning of layouts & of process technology systems of pharmaceutical manufacturing sites

2007–2009 Fresenius Kabi Product Partnering:
Director, Contract Manufacturing: Project Management Contract Manufacturing

since 2009 Fresenius Kabi:
Vice President QM-Systems & GMP-Compliance: Management of the department QM-Systems & GMP-Compliance within the Global Quality Management organisation of Fresenius Kabi AG

Mayer M.
(2005a): Die erfolgreiche Qualifizierung von Dampf-Sterilisatoren. Steriltechnik, 5, 3: 30 –31; Darmstadt (GIT)
(2005b): Kwalifikatij Sterilisatorw. 28–29; Lekarstva po GMP, No. 9 (133): 28–29; Moscow (Medizinsky Biznes).
(2005c): Simulation prior to Investment. ChemManager Europe, 2/2005: 11; Darmstadt (GIT).

Mayer M. & Häußler J.
(2005): Realisierbare Optimierungspotentiale erkennen und nutzen – Simulationsstudien von Investitionsplanungen, Prozesslogistik und Prozessverfahrenstechnik. ChemManager, 16, 6: 13; Darmstadt (GIT).

Mayer M.
(2003 & 2004): Autoclave – ECA European Conference Sterile Manufacturing – GMP/ FDA compliant Qualification and Validation; Berlin & Munich.

Mayer M.
(2005): GMP-Requirements, Standards, Norms and Guidelines – HVAC-Systems and Clean Rooms; BVRC University; Seoul.
(2005): Qualification of HVAC Systems; BVRC University; Seoul.
(2005): Qualification of Rooms – Special Requirements and Practical Experiences; BVRC University; Seoul.

Publications at Maas & Peither GMP Publishing:
    (Author of Chapter 12.C Manufacture of terminally sterilised products)