WHO publishes final Guideline for Hold-Time Studies

After the WHO had released the second draft of the guideline for the design of hold time studies in March already, it now released the final version as part of the Technical Report Series 992. Find out more about the Guideline for Hold Time Studies.



After the World Health Organisation (WHO) had released the second draft of the guideline for the design of hold-time studies in March already, it now released the final version as part of the Technical Report Series 992 (TRS 992, Annex 4).

The GMP regulations require that raw materials, packaging materials, intermediate, bulk and finished products need to be stored under suitable conditions. This also includes the definition of maximum hold-times for intermediate and bulk products prior to their further processing. The definition of these times should be justified on the basis of scientific data. This guideline aims at reflecting aspects that may be important in the design of hold-time studies. Active substances and biological products are explicitly excluded. According to WHO, hold-time studies can be part of the development or also be carried out during the later Scale-Ups. In any case they should be confirmed during product validation, though.

With coated tablets as an example the guideline demonstrates at what points in the manufacturing process samples can be taken and examined for durability. The number of batches to be examined is supposed to be risk-based. The times, according to which the listed intermediates could be sampled and examined are also mentioned exemplary. Whereas the original draft comprised propositions with regard to combined hold times – meaning the impact of hold times of various intermediates among one another – they are not part of the final guideline any more.



DR ANTHONY MELVIN CRASTO, Born in Mumbai in 1964 and graduated from Mumbai University, Completed his Ph.D from ICT, 1991,Matunga, Mumbai, India, in Organic Chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues, Currently he is working with GLENMARK PHARMACEUTICALS LTD, Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Total Industry exp 30 plus yrs, Prior to joining Glenmark, he has worked with major multinationals like Hoechst Marion Roussel, now Sanofi, Searle India Ltd, now RPG lifesciences, etc. He has worked with notable scientists like Dr K Nagarajan, Dr Ralph Stapel, Prof S Seshadri, Dr T.V. Radhakrishnan and Dr B. K. Kulkarni, etc, He did custom synthesis for major multinationals in his career like BASF, Novartis, Sanofi, etc., He has worked in Discovery, Natural products, Bulk drugs, Generics, Intermediates, Fine chemicals, Neutraceuticals, GMP, Scaleups, etc, he is now helping millions, has 9 million plus hits on Google on all Organic chemistry websites. His friends call him Open superstar worlddrugtracker. His New Drug Approvals, Green Chemistry International, All about drugs, Eurekamoments, Organic spectroscopy international, etc in organic chemistry are some most read blogs He has hands on experience in initiation and developing novel routes for drug molecules and implementation them on commercial scale over a 30 year tenure till date Dec 2017, Around 35 plus products in his career. He has good knowledge of IPM, GMP, Regulatory aspects, he has several International patents published worldwide . He has good proficiency in Technology transfer, Spectroscopy, Stereochemistry, Synthesis, Polymorphism etc., He suffered a paralytic stroke/ Acute Transverse mylitis in Dec 2007 and is 90 %Paralysed, He is bound to a wheelchair, this seems to have injected feul in him to help chemists all around the world, he is more active than before and is pushing boundaries, He has 9 million plus hits on Google, 2.5 lakh plus connections on all networking sites, 50 Lakh plus views on dozen plus blogs, He makes himself available to all, contact him on +91 9323115463, email amcrasto@gmail.com, Twitter, @amcrasto , He lives and will die for his family, 90% paralysis cannot kill his soul., Notably he has 19 lakh plus views on New Drug Approvals Blog in 216 countries......http://newdrugapprovals.wordpress.com/ , He appreciates the help he gets from one and all, Friends, Family, Glenmark, Readers, Wellwishers, Doctors, Drug authorities, His Contacts, Physiotherapist, etc

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