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GMP LOGFILE: Lead Article
Typical GMP Deficiencies at Manufacturers of Chemical APIs - An Overview
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
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
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?
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?
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
11 min. reading time | by Cornelia Wawretschek and Jens Hrach, PhD
Process Development as the Basis for Process Validation
7 min. reading time | by GMP-Verlag
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
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
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
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.
Planning, Construction and Commissioning of an Isolator
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
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
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
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
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
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)
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
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
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.