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GMP LOGFILE: Lead Article

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?

How to Maintain the Qualification Status of Your Equipment

11.01.2022

8 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. This is ensured by regular calibration, maintenance, effective change management and periodic review.

Original Data and True Copies

14.12.2021

6 min. reading time | by Christine Oechslein, PhD and Cornelia Wawretschek

 

For almost all purposes in the GMP sector, it is mandatory to use original data and documents or only true copies thereof. This requirement also forms part of the ALCOA principle. Since it is only possible in a few cases in operational practice to work with the sole original document, the question arises as to what requirements are to be placed on the requisite true copies (see definition in Figure 15.B-6). Figure 15.B-7 compares different types of copies with the concept of original data.

Supplier Qualification: Pre-Selection Process

07.12.2021

7 min. reading time | by Stephanie Blum, PhD

 

If a new service or material is required, the competent department first checks whether this service or material can be obtained from an already qualified supplier. If this is the case, the department initiates a follow-up qualification. Otherwise, the identification and pre-selection of potential new suppliers is carried out by the department itself.

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.

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