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ISPE GAMP R and D and Clinical Systems SIG publish first Concept Paper



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ISPE GAMP R&D and Clinical Systems SIG publish first Concept Paper
When changing from paper-based to computerized systems and processes in the field of Good Clinical Practice (GCP), validating these systems is of critical importance, as inspectors are increasingly focussing on this facet of clinical trials. The ISPE GAMP R&D and Clinical Systems SIG has published a Concept Paper on the application of GAMP 5 validation principles to the GCP field.  Read more here about the Concept Paper,8366,8308,Z-COVM_n.html


ISPE GAMP R&D and Clinical Systems SIG publish first Concept Paper

As the pharmaceutical industry increasingly transitions from paper-based to computerized processes, the validation of these systems is also becoming a focus of inspections in the field of clinical trials. This has resulted in an increased need for guidances and guidelines concerning GCP-regulated systems, especially since these systems play a crucial role in the life cycle of medicinal products.

Currently, there are only a few guidelines in existence which explicitly address validation activities in the field of GCP. At the same time, there is a paucity of information regarding the practical execution of regulatory requirements. Because the system landscape found in the GCP field is characterized by heterogeneous systems with multiple interfaces and system components of differing complexity and configurability, it is  necessary to find a validation approach that is flexible and scaleable.

GCP experts from the ISPE GAMP R&D and Clinical Systems SIG, led by Q-finity’s CEO, have published a Concept Paper with the intention of harmonizing the GAMP 5 validation principles with GCP requirements, using the example of an Electronic Data Capture (EDC) system. The Concept Paper addresses the particular challenges to be dealt with when validating GCP-regulated systems. In the GCP field, there is no tangible product that results from the processes in place. Instead, the “product” is data, which is collected, processed and retained in different system components. Since this data forms the basis for the final analysis of the clinical trial, and with data integrity and patient safety at stake, the systems through which the data flow must be reliable.

By demonstrating the validation approach with a practical example, the application of the GAMP 5 principles to the GCP field are presented in a very comprehensible and concrete fashion.

Author: Oliver Hermann; Q-finity
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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 LIFE SCIENCES 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 PLUS year tenure till date June 2021, 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, 90 Lakh plus views on dozen plus blogs, 233 countries, 7 continents, He makes himself available to all, contact him on +91 9323115463, email, Twitter, @amcrasto , He lives and will die for his family, 90% paralysis cannot kill his soul., Notably he has 33 lakh plus views on New Drug Approvals Blog in 233 countries...... , 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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