This presentation will guide you how to gained knowledge and flow of investigation for OOS.
1. Out of Specification Guidance- [ Ссылка ]
2. Out-of-specification investigations- [ Ссылка ]
3. Investigating Out-of-Specification Test Results for Pharmaceutical Production- [ Ссылка ]
4. Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production [ Ссылка ]
5. OMCL Network of the Council of Europe QUALITY ASSURANCE DOCUMENT- edqm.eu/sites/default/files/medias/fichiers/OMCL_Network/Find_information_on/Quality_Management_Documents/omcl_evaluation_and_reporting_of_results_-_annex_1a_model_template_for_failure_investigation_of_oos_results.pdf
This Video Presented By:
Palash Chandra Das, M.Pharm (Pharmaceutical Chemistry)
About Myself:
I have completed my B.Pharm and M.Pharm in Pharmaceutical medicinal chemistry from WBUT. In the year 2010, I started my journey in the Pharmaceutical Industry. In my career I worked with the F & D, Production and Quality Assurance department etc. I have a good exposure in several Sterile Green field and Brown field projects. Involved in various regulatory audit like CDSCO, WHO, USFDA,TGA,MHRA, GERMAN, UKRAINE, ANVISA-Brazil, INVIMA-Colombia, RUSSIA, IRAN, PMDA-Japan, South Korea etc.
Core Technical Skill:
Sterile Injectable dosages form (SVP and LVP ) with liquid and lyophilized form
Qualification & Validation , Computer System Validation, Sterility Assurance, Quality Management System, Risk Management, cGMP training, Failure Investigation , Auditing
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Admin and Member of "Global Federation of Pharmaceutical Industrial Association"
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