GMP LOGFILE: Lead Article

5 min. reading time | by Sabine Paris

Are you already training online or still offline? What do the employees, the management, the works council and other stakeholders want? How can this be controlled and GMP-compliant? How can blended learning be implemented?

6 min. reading time | by Doris Borchert

Would you have known? Around 90% of all product recalls by pharmaceutical companies are due to errors in printed packaging materials. It is not the quality of the drug itself that calls into question patient safety, but incorrect or erroneous information on the packaging. A comma on our bank statements can bring tears to our eyes or a smile on our lips.

7 min. reading time | by Sabine Paris

The European Annual Conference of the International Society of Pharmaceutical Engineering (ISPE) attracted over 700 participants to Dublin from 1st to 3rd April 2019. The main topic was “Drive and Leverage Innovation for Pharma”. The Executive Forum focused on the industrial digitisation as a key enabler to drive innovation. Driving continuous improvement in a digital age needs a number of pre-requisites and face new challenges and opportunities.

9 min. reading time | by Paulino Alonso

The ICH Q3D Guideline for Elemental Impurities came into effect on January 2018 for all the products for human use. To date, most of the companies have finished the implementation (maybe not at 100%, but ongoing) and now, the challenge is to keep the reports updated.

5 min. reading time | by Ulrike Reuter

Significance of risk analysis for a qualification

A risk analysis is a fundamental element of a qualification because the content and extent of the qualification tasks are determined therein.

7 min. reading time |

Introduction

Despite much discussion about the subject over the past three years in particular, data integrity issues remain a common feature on 483 letters issued by the U.S. Food and Drug Administration and data handling matters are also a focus of enforcement actions (as well as inspection findings from other regulatory agencies).

5 min. reading time | by Josef Künzle

Change analysis (CA)

The calibration of analytical instruments is stipulated in the GMP Guidelines.

8 min. reading time | by Doris Borchert

There are no regulatory requirements for the definition of air quality and its monitoring in non-sterile production areas. The topic was discussed by our team of experts and in some cases very different answers were received. The different points of view made us curious - how is this question solved in pharmaceutical practice?

5 min. reading time | by Fritz Röder

As in the case of all qualifications, the risk analysis is carried out to consolidate the knowledge of all the parties involved and define the necessary test and action points required for the qualification. This is an extremely time-consuming process.

4 min. reading time | by Christine Oechslein

E-learning can be seen as didactically meaningful support in the learning process. More and more people prefer to use their PCs and the internet instead of attending seminars or reading documents. The younger generation in particular, who grew up with computers, can absorb a lot of learning content better and faster through e-learning, or can already work out familiar contents in addition.

4 min. reading time | by Harald Flechl

A cost-optimized approach to project planning and execution, including the use of BIM (Building Information Modelling), will be used increasingly in the future. If this technology is applied correctly and over the entire project sequence, it makes it possible to optimise the planning, execution and usage of buildings, furnishings and installations using digitally prepared product data and software.

8 min. reading time | by Dr. Sabine Paris

The new Annex 1 of the EU GMP Guide is to be finalised in December 2018. The publication is planned for spring 2019. Which changes will surely come, where is there still a need for discussion? Where are your ambiguities?

9 min. reading time | by Sabine Rabus

This summary review of GMP documents published in 2018 provides an overview on developments in important international legislation and regulations.

4 min. reading time | by Cornelia Wawretschek

Personnel

5 min. reading time | by Hanfried Seyfarth

Actions to be taken when levels are exceeded and the related responsibilities should be described in detail in a separate SOP. The Monitoring SOP should include a reference to this SOP.