FAQ – Questions and answers
We’d like to answer the most important questions about our MPL topics on the following pages. We want to offer you a broad insight into everything concerning the implementation of ISO 13485, ISO 17025 and our chosen fields of competence regarding GMP and laboratory. Please also check our Blog where we regularly post new articles.
If you have other questions, please don’t hesitate to contact us.
(This page is currently still under construction and is being expanded continuously.)
ISO 13485 and ISO 17025
Method transfer
Procedure and requirements for method transfers
Planning phase – Preparing a method transfer
Types of transfer and tranfer strategy
Acceptance criteria of comparative method transfers
Method validation
Verification of compendial methods
For additional information please check our blog category Method validation.
Filter validation
Filter validation: Aspects to be considered
Filter validation: Information from the filter supplier
Filter validation: Product-specific studies that need to be conducted by the filter user
Filter integrity tests – principles and influencing variables
Filter validation: The bacterial retention test according to ASTM F838-15-a
News and further articles can also be found in our blog category Filter validation.
HPLC
Troubleshooting and optimization for the HPLC
Further articles about e.g. HPLC pressure differences, peak width, method optimization are posted within the blog category HPLC.