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

What is ISO 13485?

What is ISO 17025?

 

Method transfer

Procedure and requirements for method transfers

Planning phase – Preparing a method transfer

Types of transfer and tranfer strategy

Content of a transfer plan

Acceptance criteria of comparative method transfers

 

Method validation

What is 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.

 

Examples for technical-scientific documents

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