Blog of the MHRA on Transfer of Analytical Methods

Recommendation

21/22 September 2022
Heidelberg, Germany

HPLC Data Integrity

The regulatory authority of the United Kingdom, the MHRA (Medicines and Healthcare products Regulatory Agency), regularly provides information on GMP-relevant topics in a blog on its website.

In August 2021, the topic "transfer of analytical methods" was addressed here and the GMP requirements listed. In this blog edition the tasks of the transferring parties are exemplified and explained.

Frequent Findings

Likewise, a list of frequently occurring deficiencies and sources of error can be found in this post. According to the MHRA, the following points are among the most frequent findings in the subject area "transfer of analytical methods":

• Equipment not qualified for the transferring method 
• The transfer protocol is not followed 
• The transfer is performed for only one strength of product, although the method is used for additional strengths 
• Methods reference documents from the transferring party, which are not available in the receiving laboratory 
• The GAP analyses are not complete 
• The method transfer was only performed on one batch with one test of each of the different methods (assays/dissolution, etc.)

To get more details please see the MHRA Inspeectorate Blog "transfer of analytical methods".