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GMP LOGFILE: Lead Article

Qualification of Water Supply Systems – Introduction


4 min. reading time | by Fritz Röder

Pharmaceutical water systems are used for a number of different applications by pharmaceutical manufacturers. These include, for example, the cleaning of various pieces of equipment, the generation of pure steam and the use of water as an ingredient for solid, semi-solid and liquid medicinal products.

Document and Evaluate GMP Audit Information and Findings


7 min reading time | by Stephanie Blum, PhD

In the course of an audit, the auditors collect the information necessary to achieve the audit objectives on a sample basis, e.g. by inspecting premises, observing operations, interviewing personnel and examining documents and records. Interviews may be conducted at any time during the audit, including during the walkthrough and review of documentation.

Deviations Happen because People Make Mistakes...


8 min. reading time | by Thomas Peither

In this feature we take look at the ‘black sheep’ of pharmaceutical production. As cute and charming as they may be in the animal world, in the world of GMP they can be rather disturbing.

7 Questionnaire Blocks for PLC User Requirements


9 min. reading time | by Petra Berlemann and Thomas Peither


User Requirements, User Requirements Specification (URS), Specification Sheet

What is it? How do you create such documents? Is it all the same? Or is it something completely different?

How to Maintain the Qualification Status of Your Equipment


9 min. reading time |


The life cycle of an equipment begins with initial qualification and ends with decommissioning. Once a qualification status has been achieved, it must be guaranteed over the entire life cycle until the equipment is decommissioned.

Insight at Second Glance - The Human Error and its Root Causes


13 Min. reading time | by Doris Borchert, PhD, and Christian Gausepohl, PhD


To err is human - and is only too willingly used as the most probable cause for deviations of all kinds. It is also temptingly easy to look for the cause of error in individual (mis)behaviour.Everyone has a bad day, is distracted or unfocused, forgets or mixes things up and makes mistakes, even though they "actually" know how to do it correctly.

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


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


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


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


Cleaning Validation

4 Questions on the Import of Medicinal Products and APIs


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.

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


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.

Why is it Necessary to “Manage“ Quality?


6 min. reading time | by Christine Oechslein, PhD

The quality of a medicinal product cannot be left to chance, but must be the result of carefully planned actions. The sequence "planning, acting, evaluating, improving" is referred to as "management".

Reaching the next GMP Level with Inspection Readiness Projects


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

Definition of Hygiene Zones


7 min. reading time | by Christine Oechslein, PhD

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


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


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


7 min. reading time | by Alexandra Fürst


CAPA Systems: Autonomous or Integrated?


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


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


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.

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