Stay informed!

Register now for the free GMP newsletter LOGFILE
and don't miss any news.

GMP LOGFILE: Lead Article

Process Models for the Validation of Excel Applications

30.11.2021

8 min. reading time | by Thomas Trantow, PhD

 

Definition of the types of Excel applications

Responsible Person according to GDP at the Logistics Service Provider

23.11.2021

8 min. reading time | by Simone Ferrante

 

In Europe, companies with a wholesale distribution authorisation, the management must appoint a responsible person who is responsible for the introduction and implementation of a quality management system and compliance with the GDP rules.

Cleanrooms: The Path from Concept to Qualified System

16.11.2021

6 min. reading time | by Harald Flechl

 

Good Engineering Practice (GEP) for procurement

Beginning from the definition of the User Requirements Specification (URS) the planning phase is subdivided into four stages:

Smart Deviation Management – Vision or Reality?

09.11.2021

5 min. reading time | by Felix Tobias Kern, PhD and Liwa Schneider

 

The GMP-compliant and timely management of deviations is very often addressed in audits. One reason for this is that deviations reveal gaps in the defined quality systems or indicate that they have not been set up correctly.

Typical GMP Deficiencies at Manufacturers of Chemical APIs - An Overview

02.11.2021

7 min. reading time | by Norbert Waldöfner, PhD

 

Figure 20.F-24 provides an overview of the GMP deficiencies that, in the author's experience, are frequently encountered during audits of active substance manufacturers.

Non-Sterile Drug Products: Microbial Risks

26.10.2021

6 min. reading time | by Sabine Paris, PhD

 

The PDA/FDA Joint Regulatory Conference, which is now in its 30th year, took place as a virtual event from September 27 – September 29. The Conference focused on the role of effective quality systems in ensuring an ongoing state of control throughout the product lifecycle by vigilantly managing risks to manufacturing and quality.

Packaging Material Testing: The Role of Your Suppliers

19.10.2021

7 min. reading time | by André Deister, Sabine Mendel

 

The supplier of the packaging materials plays an important role when pharmaceutical packaging materials undergo testing. Because of the numerous materials involved, the complexity of the manufacturing process and the extremely specific test parameters, many of the packaging material tests are carried out at the supplier.

What’s new for ICH Q9 and ICH Q12?

12.10.2021

7 min. reading time | by Sabine Paris, PhD

 

The PDA/FDA Joint Regulatory Conference, which is now in its 30th year, took place as a virtual event from September 27 – September 29. The Conference focused on the role of effective quality systems in ensuring an ongoing state of control throughout the product lifecycle by vigilantly managing risks to manufacturing and quality.

Defect Evaluation Lists and Defect Pattern Libraries Create them yourself – but how?

05.10.2021

7 min. reading time | by Felix Tobias Kern, PhD, and Fritz Röder

 

Defect evaluation lists and defect pattern libraries are popular GMP documents that have been used for more than 45 years. They serve as a rationale for the quality assessment of individual batches and set quality standards for the manufacture and testing of pharmaceutical products.

Basis of Cleaning Validation: Setting of PDE Limits

28.09.2021

11 min. reading time | by Cornelia Wawretschek, Jens Hrach, PhD

Process Development as the Basis for Process Validation

21.09.2021

7 min. reading time |

 

A GMP compliant and successful process validation is only possible when a 'robust' 1 pharmaceutical development of the medicinal product has been performed, regardless of which development methods are applied.

Test interval for integrity testing of HEPA filters in a laminar flow above an injection moulding machine

14.09.2021

12 min. reading time | by Harald Flechl

 

Question:

We operate a laminar flow above an injection moulding machine in a cleanroom, GMP Grade C (ISO 8 in operation, ISO 7/at rest). The laminar flow achieves ISO class 5 within the cleanroom area.

IT Service Providers: Service Level Agreement

07.09.2021

8 min. reading time | by Markus Roemer, Siegfried Schmitt, PhD

 

The written contract on the outsourced activities can take the form of an internal service agreement or an external service agreement. In both cases, it is used to describe.

 

Stability Studies During the Authorisation Phase of Medicinal Products

31.08.2021

7 min. reading time | by Heike Meichsner, Olaf Mundszinger, PhD, Susanne Schweizer

 

The registration batches correspond as nearly as possible to the later commercial batches in the marketing phase with regard to the equipment, starting materials and manufacturing processes used.

Remote, Distance, Offsite or Virtual Audits?

24.08.2021

12 min. reading time | by Thomas Peither

Planning, Construction and Commissioning of an Isolator

03.08.2021

8 min. reading time | by Richard Denk

 

Isolator applications and design

Isolators are used in the handling of toxic and highly potent substances and in the production of sterile products.

Practical implementation of the PQS

27.07.2021

9 min. reading time | by Stephanie Blum

 

In addition to the preceding general statements on the PQS, Chapter 1 of the EU GMP Guidelines contains specific information on GMP for medicinal products and quality control.

GMP Inspections: Organisation of the Front and Back Office

20.07.2021

9 min. reading time | by Thomas Peither

 

The inspection is carried out in the front office and prepared in the back office. The preparation room is used to train and instruct staff.

Qualification Master Plan: Regulatory Requirements

14.07.2021

11 min. reading time | by Thomas Peither

 

A definition of the term “qualification master plan (QMP)“ is not to be found in the GMP guidelines, only the term “validation master plan (VMP)”, which serves as a parent document.

Alternative Approach to Risk Assessment of Computerised Systems

06.07.2021

9 min. reading time | by Dennis Sandkühler

 

On the basis of the process-related requirements set out in the specifications, ISPE GAMP® 5 provides for a process risk analysis to identify risks relating to patient safety, product quality, data integrity and compliance requirements.

Do you have any questions?

Contact us:

Phone +49 7622 66686-70
E-mail: service@gmp-publishing.com