Tuesday, 27 August 2013

WHO: General guidance for inspectors on “hold-time” studies


The World Health Organisation (WHO) has issued the following document for comment: “General guidance for inspectors on “hold-time” studies revised draft for comment”.

According to the guideline: “Arrangements should exist to ensure that the dispensed starting and packaging materials used, intermediate products, bulk and finished products are stored under appropriate conditions. Storage should not have any negative effect on the processing, stability, safety, efficacy or quality of the materials, intermediate products and bulk products prior to final packing.”

Furthermore: “Good manufacturing practices require that the maximum allowable hold time should be established to ensure that in-process and bulk product can be held, pending the next processing step, without any adverse effect to the quality of the material.”

To access the draft, see WHO

The closing date for comments is 15 September 2013.

Posted by Tim Sandle