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GMP LOGFILE: Lead Article

GMP is not ISO 9001 – Where are the Similarities and Differences?

29.11.2022

7 min. reading time | by Thomas Peither

 

Standards such as those in the DIN EN ISO series are not laws, so ISO standards differ quite fundamentally from legally binding regulations. Good Manufacturing Practice (GMP), on the other hand, is laid down in laws, regulations and guidelines.

Qualification Master Plan: Regulatory Requirements

15.11.2022

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.

Basis of Cleaning Validation: Setting of PDE Limits

01.11.2022

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

 

Cleaning Validation

4 Questions on the Import of Medicinal Products and APIs

18.10.2022

6 min. reading time | by Simone Ferrante

 

GMP or GDP – Which applies for importation?

Although the import of medicinal products is an act related to dis-tribution and logistics, this activity is considered GMP relevant in the EU and is therefore subject to GMP requirements.

Self-Inspection – How to Identify Your GMP Weaknesses Before the Authority Does

04.10.2022

8 min. reading time | by Thomas Peither

 

There is nothing worse than being caught cold and only noticing during an official inspection where things are sticking and going wrong in your own company. In any case, this entails effort and time delays, not to mention more serious consequences such as a finding.

The new Annex 1 for the Manufacture of Sterile Medicinal Products – Focus: Barrier Systems

30.08.2022

8 min. reading time | by Richard Denk

The first draft of version 9 of Annex 1 of the EU GMP Guide on 20 December 2017 attracted a lot of interest globally – firstly because it was the first publication on the topic in almost a decade, and secondly because PIC/S and WHO co-authored the document.

Reaching the next GMP Level with Inspection Readiness Projects

26.07.2022

9 min. reading time | by Frank Studt and Thomas Peither

Definition of Hygiene Zones

12.07.2022

7 min. reading time | by Christine Oechslein, PhD

How is process validation differentiated from other elements of quality management?

14.06.2022

8 min. reading time | by Thomas Peither

 

The question "How does process validation differentiate itself from other elements of quality management?" is not easy to answer, because there is still no uniform and generally applicable definition for validation. On the contrary, the term is becoming increasingly blurred with the related technical terms qualification and verification.

Import of Medicinal Products – Clarifications in Annex 21

31.05.2022

10 min. reading time | by Sabine Paris, PhD

 

The new Annex 21: Importation of medicinal products to the EU GMP Guide has been published on February 21, 2022 and will enter into force on August 21, 2022. The 6-page annex summarises the GMP requirements for Manufacturer/Importer Authorisation (MIA) holders to import medicinal products (human, investigational and veterinary) from outside the EU/EEA (we reported).

Initial Classification of a Commercial Return (CR) by the CR Coordinator

17.05.2022

7 min. reading time | by Alexandra Fürst

 

CAPA Systems: Autonomous or Integrated?

03.05.2022

8 min. reading time | by Thomas Peither

 

A CAPA system should be understood as an important element of the pharmaceutical quality system and implemented uniformly throughout the company or group. In principle, it can be implemented in two different ways: as an autonomous or as an integrated system.

Risk analysis in the equipment life cycle

19.04.2022

5 min. reading time |

 

From the start of the project to the release of the technical design: Risk analysis is a constant companion.
Risk analyses can or must be carried out at different points in time within the process of procurement and qualification. Here is a brief outline of the phases of risk analyses in project implementation.

13 GMP Requirements for Excipient Manufacturers

05.04.2022

7 min. reading time | by Stephanie Blum, PhD

 

Based on the risk assessment documented in the excipient dossier and the risk profile of the excipient, the risk team defines the necessary GMP requirements in the next step.

Deviation Causes as KPIs – Collection vs. Assessment

22.03.2022

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

 

Deviation management plays an increasingly important role in the collection and review of KPIs (Key Performance Indicators) for pharmaceutical production and quality processes. Tracking the cause of deviations in particular provides information on how stable the respective processes are, where there are gaps and where countermeasures need to be taken with corrective and preventive actions (CAPAs).

Comparison of cleaning processes

08.03.2022

7 min. reading time | by Torsten Knöpke

Nitrosamines: Authorities‘ Expectations and Typical Mistakes

22.02.2022

8 min. reading time | by Sabine Paris, PhD

 

"Contaminants in medicinal products – focus on nitrosamines" was the title of an online training course organised by the German FORUM Institute on 12 November 2021. Four renowned experts from the authorities, industry and consulting shed light on all aspects of nitrosamines that play a role in the life cycle of a medicinal product:

9 Check Points for the Incoming Goods Protocol at the Logistician's or Wholesaler's Premises

08.02.2022

8 min. reading time | by Simone Ferrante

 

Receipt of medicinal products

When materials or products are delivered, their quality is assessed. Therefore, this work step should be carried out by experienced and particularly reliable employees.

Update on Annex 1 of the EU GMP Guide

24.01.2022

7 min. reading time | by Doris Borchert, PhD

 

The 27th PTS GMP Conference took place face-to-face and in parallel digitally from 30.11. to 01.12.2021 in Mainz, Germany. The hybrid event was broadcast live from the Atrium Hotel in Mainz, where most of the speakers were present in person.

The presentation by Rico Schulze, Saxon State Ministry for Social Affairs and Social Cohesion, on the revision status and publication of Annex 1 to the EU GMP Guideline was particularly eagerly awaited.

The GMP Regulations Report 2021

18.01.2022

13 min. reading time | shortened version

 

From a regulatory perspective, the year 2021 had plenty in store. Parallel to the omnipresent COVID-19 pandemic, the authorities around the world managed to finalize draft documents that became “sideshows” while the pandemic took centre stage. What topics kept the GMP professionals on their toes?

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