GMP LOGFILE: Lead Article

Quality Metrics – Bane or Boon?

GMP Talk with Experts Claudia Pachl and Ruven Brandes

by Dr. Sabine Paris

Sanitisation

Exclusive Excerpt from the new pdf download The New USP <1231>: Water for Pharmaceutical Purposes

by Fritz Röder

Microbiological monitoring of cleanrooms – regulatory requirements

Excerpt from the GMP Series pdf download Monitoring of HVAC Systems in GMP Environments

by Dr. Hans H. Schicht

Problems with the Regulatory Culture

by Robert G. Kieffer, Ph.D.

Air cleanliness grades and associated process steps

Excerpt from the GMP Series pdf download Classes and Grades for Air Cleanliness

by Dr. Hans H. Schicht

Work instructions, records and documentation –
How do you keep track?

An excerpt from GMP Fundamentals

by Dr. Christine Oechslein

The New Annex 16 – Eight Questions for Dr. Rainer Gnibl

Laboratory data management systems (LDMS)

An excerpt from GMP Series How to design a Laboratory Data Management System

by Dr. Ulf Fuchslueger

Warehousing

An excerpt from the GDP Audit Checklist

Specifications for packaging materials

An excerpt from GMP Series Sterile Manufacturing: Barrier Systems, Isolator and Safety Cabinets

by Andreas Nuhn, Dr. Hans H. Schicht

What does the new Annex 1 have in store for us?

by Thomas Peither, Maas & Peither AG

Qualification of Single-Use Component: The Need for Standardization

by Christopher Smalley

Storage and shelf life of laboratory substances

An excerpt from the GMP MANUAL

by Dr. Markus Limberger

Specifications for packaging materials

An excerpt from GMP Series GMP Compliance Basics of Packaging Materials and Processes

by Ruven Brandes, Dr. Christian Gausepohl, Roland Kleissendorf

Types of Biotechnological Active Substances

An excerpt from GMP Series Managing GMP Requirements in Biotech API Manufacturing

by Dr. Rainer Gnibl

Physical monitoring of cleanrooms

An excerpt from GMP Series Monitoring of HVAC Systems in GMP Environments

By Dr. Hans H. Schicht

Technology Transfer Phases

An excerpt from GMP Series A Successful Concept for Technology Transfer in Drug Manufacturing

By Dr. Christian Gausepohl

Process Validation – How do I implement the new GMP requirements?

Results of the GMP Conference in 2015

Report by Dr. Sabine Paris

Deviations – Definition and Requirements

An excerpt from GMP Series Implementing a World Class Deviation Management

By Dr. Christian Gausepohl

Possible risks of manufacturing and packaging

An excerpt from GMP Fundamentals 

by Dr. Christine Oechslein