GxP-Blog

Blog
What is the GMP management review of your quality system worth?
The GMP management review is a formal GMP requirement and one of the elements of the pharmaceutical quality system.
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Blog
Missing or insufficient: Maintaining the validated state of the cleaning validation
Pharmaceutical manufacturers must ensure that the drugs they manufacture are free from cross-contamination and impurities. Raw materials, intermediates or pharmaceuticals are possible cross-contaminations.
Blog
At record speed to the patient – development of a Transport Verification Master Plan (TVMP).
For the global introduction of a new pharmaceutical product, Chemgineering took on the important role of developing a master plan for transport verification.
Blog
Self-inspection of quality assurance in the pharmaceutical quality system
Periodic self-inspections of the pharmaceutical quality system are mandatory for pharmaceutical manufacturers in the EU
Blog
Quality Oversight in the GMP Quality System
This article describes , the measures that pharmaceutical manufacturers should implement in preparation for this requirement.
Blog
Deviations as essential quality parameters in the pharmaceutical quality system
This is the best way to prepare for the critical exam.
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Blog
Data evaluation during GMP validation
In this way, unnecessary complications can be avoided as early as the selection of acceptance criteria.
Blog
Requirements for Hand Sanitizers – Often Underestimated!
Clarify requirements for hand sanitizers at an early stage
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Blog
Careful management of specifications makes pharmaceutical products safe - Part 4
The "Careful handling of specifications in pharmaceutical quality systems“ theme is dealt with as a four part BLOG article. Read the fourth and final part of the blog series here.

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