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GMP LOGFILE: Lead Article

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.

Frequent Deficiencies in GMP Inspections – Here: Insufficient Maintenance of Rooms

29.06.2021

9 min. reading time | by Lea Joos

 

The deficiency

During a tour of the production area, it was discovered at several points that the rooms were not sufficiently maintained:

GMP:READY - Specialist Knowledge GDP Compact (Bundle 11 A+B)

22.06.2021

7 min. reading time | by Stephanie Blum

 

With this e-learning course you can get familiar with the topic of Good Distribution Practice (GDP)!

Requirements for Balances Used in Pharmaceutical Production

15.06.2021

10 min. reading time | by Christian Gausepohl

 

When selecting balances, technical aspects such as resolution, precision and weighing range must be taken into account, as must special design features.

Design Qualification for Premises and Air Handling Units

08.06.2021

7 min. reading time | by Harald Flechl

 

The design qualification process may vary depending on the project and the client's requirements and may be carried out in two or three design phases.

Contract Manufacturing: Technology Transfer Phases

01.06.2021

10 min. reading time | by Chistian Gausepohl

 

The transfer of a product to a contract manufacturer can be divided into different phases.

Survey of qualified persons on remote certification

25.05.2021

15 min. reading time | by Ulrich Kissel and David Cockburn

 

Social distancing posed an interesting question for the Qualified Person (QP) in the early days of the COVID-19 pandemic:

Importance of Supplier Qualification Status

18.05.2021

7 min. reading time | by Christian Gausepohl

 

Most companies have established different categories (qualification status) for the suppliers of starting materials and packaging materials they use.

Innovations in Pharmaceutical Manufacturing

11.05.2021

8 min. reading time | by Thomas Peither

 

Were you able to follow the PDA Annual Meeting of the Parenteral Drug Association this year? Or were you like many others who spent the whole day with web meetings and have no time or mood for more online conferences?

European Safety Referral: Short and Crisp

04.05.2021

4 min. reading time | by Michael Hiob and Sabine Paris

 

A referral is a procedure used to resolve concerns over the safety, efficacy or quality of a medicinal product (or a class of medicines). In a referral, the EMA is requested to conduct a scientific assessment of the products in question on behalf of the European Union (EU).

The GMP:Blog is online!

27.04.2021

The time has come, the curtain goes up! Now your brand-new online journal is launched.
Let the newly designed GMP:Blog support you in the work with GMP.

Specifications for packaging materials

20.04.2021

5 min. reading time | by Roland Kleissendorf

 

A correctly formulated packaging material specification provides a comprehensive description of the packaging material and serves as a guideline for the respective packaging materials supplier.

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