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FDA gives Advice on the Use of Control Charts

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see………………..http://www.gmp-compliance.org/enews_05135_FDA-gives-Advice-on-the-Use-of-Control-Charts_15093,15290,15250,15405,Z-VM_n.html

In our News entitled “Statistics and Process Validation: current Findings of the FDA“, we pointed out that the FDA has been observing more and more deficiencies in the area of statistics with regard to process validation. One of the “statistical methods” – also stated in FDA’s Process Validation Guidance – is the use of control charts in the context of a statistical process control (SPC). A SPC can be a valuable resource, particularly in stage 3 of the process validation lifecycle (continued/ongoing process verification).

During an event with the Product Quality Research Institute (PQRI), Dr Daniel Peng from CDER’s Office of Processes and Facilities (OPF) presented his views on the use of SPC under the heading “Using Control Charts to Evaluate Process Variability”. He began with the history of control charts and their fields of application. He furthermore considered the most important rules to create and manage control charts, including types of control charts, sampling and evaluation rules according to the Western Electric Rules.

He concluded his presentation with examples of control charts for evaluating intra and inter-batch variabilities and site performance monitoring.

The slides of the presentation “Using Control Charts to Evaluate Process Variability” are very easy to read and available for free.

Are you interested in SPC and control charts? On 18/19 February, the ECA organises the Education Course “Statistical Process Control – A key tool for process understanding in the process validation life cycle” in Heidelberg, Germany.


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DR ANTHONY CRASTO

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DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO Ph.D

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 29 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 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 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 29 year tenure till date Aug 2016, Around 30 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, 25 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 13 lakh plus views on New Drug Approvals Blog in 212 countries......https://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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