GMP LOGFILE: Lead Article

Environmental Monitoring for Non-Sterile Manufacturing: Establishing Where to Sample

Excerpt from the PDA/DHI book Contamination Control in Healthcare Product Manufacturing, Volume 5

5 minutes reading time

by Crystal Booth

Sliding doors in cleanrooms - "no go" or "best practice"

Shortened and edited excerpt from the GMP Compliance Adviser, Chapter 3.E "Cleanroom Construction Components"

5 minutes reading time

by Harald Flechl / Doris Borchert, PhD (editorial editing)

Inadequate handling of deviations: the cause "human error"

Shortened excerpt from the GMP Compliance Adviser, Chapter 21.C Frequent deficiencies in GMP inspections, their recurring pitfalls and how to avoid them

5 minutes reading time

by Lea Joos

Late, but not too late? How to best define the final time point of a stability study?

Ask our Experts

5 minutes reading time

How do you organize GMP knowledge and relevant news in your organization?

8 minutes reading time

by Thomas Peither

Two different pairs of boots: GMP for APIs and GMP for medicinal products

Abridged and edited extract from the GMP Compliance Adviser, Chapter 20.A Introduction to "Active Pharmaceutical Ingredients“

5 minutes reading time

by Rainer Gnibl, PhD

Filter integrity test

Excerpt from Chapter 12.E.4.3 Filter integrity test of the GMP Compliance Adviser and GMP Series Aseptic Processing

7 minutes reading time

by Ruven Brandes

Substance-based medical devices

Certainty and challenges due to the new EU Medical Device Regulation

5 minutes reading time

by Felix Tobias Kern

Ask our Experts GMP–compliant documentation: Handling of glued-in printouts

7 minutes reading time

Work instructions, records and documentation

An excerpt from the Step-by-Step Guide GMP Fundamentals

5 minutes reading time

by Christine Oechslein, PhD

Hygienic design of pharmaceutical manufacturing processes - example: tablet press

Excerpt from Chapter 4.3 Hygienic Design of the GMP Compliance Adviser

5 minutes reading time

by Richard Denk

GMP:READY: GMP for Engineers

GMP Training: Simple and Online 24/7

5 minutes reading time

Ask Our Experts – Validity period of FDA Certificates of Conformity?

7 minutes reading time

FMD alerts in 2020 – where we are a year into legislation

9 minutes reading time

by Grant Courtney

Environmental Risk Assessment: ERA Reports

Excerpt from our Guideline Evaluation of the environmental risks of medicinal products: ERA reports

8 minutes reading time

Purpose and content of a management review

An excerpt from the GMP Series e-book The Road to a Pharmaceutical Quality System

5 minutes reading time

by Stephanie Blum

Challenges lurking in manufacturing

A GMP-DIALOGUE of our GMP conference, the GMP-BERATER-Days, in October 2019 revolved around the topic "Challenges lurking in manufacturing". Questions on the topic were asked by participants and answered by the experts in a lively discussion.

Experts:            GMP inspector Lea Joos, Christian Gausepohl, PhD, QP and Head of Quality Unit

Protocol:           Sabine Paris, PhD

12 FREQUENTLY ASKED QUESTIONS on SOPs

This text is an excerpt from the DHI/PDA Book SOPs Clear and Simple: For Healthcare Manufacturers

7 minutes reading time

by By Brian Matye, Jeanne Moldenhauer, Susan Schniepp

Nothing ventured, nothing gained

- On dealing with risks in the manufacture of medicinal products

An excerpt from the GMP Compliance Adviser, Chapters 19.A Agency expectations of quality risk management and 19.B Application and benefits of QRM in the pharmaceutical industry

Disruptive technologies in the production of pharmaceuticals

A GMP-DIALOGUE of the GMP Conference, the GMP-BERATER Tage, in October 2019 revolved around the topic "Disruptive technologies in the production of pharmaceuticals". The participants asked questions about the topic, which the two experts answered in an exciting discussion.

8 Min. Lesezeit

Experts:                Martin Düblin, One One Eleven GmbH and GMP inspector Rainer Gnibl (PhD)

Moderation:         Barbara Peither

Protocol:               Nadja Schaubhut