Updating international standards for pharmaceutical waters
Supported regulatory department by providing Validation documents and other documents required for the regulatory submissions and queries from various regulatory agencies such as FDA, MCA and MCC PROFESIONAL QUALIFICATIONS . Prepared and reviewed CMC documents including QOS, protocols, methods (STPs), specifications and Validation reports. Strong experience in c GMP, c GLP, ICH and FDA compliant environment . by qualifying various instruments, writing SOPs and making various systems to channelize work flow process. Proposed and Prepared templates for Manufacturer Qualification Report, Method Development Report, Method Validation Protocol and Report, Method Transfer Protocol and Report. Performed various investigations related to (OOS & Laboratory incidents) some unusual observations like extra peaks observed during scale-up process, unusual increase in the total related substances, new peaks observed during stability samples analysis, variation in results, out of specifications results, variations in the assay of same samples on different days, variation in the retention time of preservative peak on different days etc. Wrote "Guidelines for Analytical Methods Validation" - A detailed guidelines to carry out validation of analytical methods for Dr. Good manufacturing practices in Chemical Development by Scientific update.( Jan 2002 ) .
Strong experience in Method Development, Method Validation & Method transfers. Development & Validation includes critical test like Assay, Related compounds, Residual Solvents, Dissolution, Content uniformity, Blend uniformity, PSD etc., . Able to support regulatory and compliance department during FDA inspections. Coordinating & resolving analytical issues within the QC department. Developed several user friendly Stability indicating methods. Performed IQ/OQ/PQ and Calibrations of analytical instruments. Developed and validated methods pertaining to Solid Oral dosage forms (Immediate, Delayed & Controlled released), carried out various investigations during the development of the drug product and prepared reports; performed stability testing at development stage including pre-formulation studies & photostability testing of drug product.
Major activities involve Planning and Releasing of In-process, Finished product Samples and Stability samples of Exhibit batches. Responsible for Compliance to system SOPs, c GLP, c GMP, FDA and other regulatory requirements and ensuring compliance with all company policies and procedures. Developed and performed several method validations and transfers for drug substances and products for CMC submissions of ANDA's. Analyzing formulation development and stability samples which involves critical evaluation of following product parameters. Studying the In-Vitro dissolution profiles of the development samples. Training the trainee officers and staff in instrumental SOP's, STP's and System SOP's. Preparation of validation protocols, Reports and summary reports. Addressing the OOS (Out Of Specifications) Laboratory incidents ( Quality impacting as well as Non-impacting ) Deviations. Responsible for writing and updating SOP's and analytical test methods . Apr 2001-Mar 2004 Group leader, Analytical R&D Apr 1999-Mar 2001 Analytical Research Scientist Aug 1997-Mar 1999 Sr.
Invagen Pharmaceuticals Inc, NY, USA Mar 2004-May 2008 Group Leader, Analytical R&D Invagen is a pharmaceutical company involved in early phase development of proprietary oral solid dosage generic products. Major activities involve Planning and Releasing of In-process, Finished product Samples and Stability samples of Exhibit batches, Commercial batches and Validation batches in Quality Control Department. Responsible for Compliance to system SOPs, c GLP, c GMP, FDA and other regulatory requirements; ensuring compliance with all company policies and procedures. Research Associate Aug 1996-July 1997 Research Associate .
Both the (USP) and the International Conference on Harmonization (ICH) have updated, or are in the process of updating, analytical requirements for controlling elemental impurities.
Others, such as catalysts, are intentionally added during the synthesis, while some are introduced unintentionally through interactions with processing equipment and/or container closure systems. Most importantly, it is a qualitative method that involves the reaction of metallic impurities with sulfide ions to generate a colored precipitate.Lengthy process USP began the standards-setting process in 2008.Several public meetings and USP Pharmacopeial Education courses were held to gather and share user input.The company has got approval for about 30 ANDA's and about 15 ANDA's are under pipeline. Developed, validated and transferred HPLC, GC, PSD and Dissolution methods .Maintained the records of test data in conformance with the company and regulatory policies . Reverse Phase HPLC Method Development, Waters Corporation ( March 2006 ) .
Responsible for supporting product development department by analyzing In-Vitro Dissolution profiles, samples from preformulation studies, product development and optimization studies and accelerated stability studies . HPLC instrumentation training by Agilent technologies in Singapore ( July 2003 ) .