Pratik Mistri

Analytical Development Laboratory -

• Management of Method validation / Method transfer activity. Review and approval of Method validation / method transfer protocols and reports.
• Method development for Assay, RS, Dissolution, Residual solvents and other QC test for Solid oral and Injectable dosage forms.
• Spreadsheets (Excel sheets) preparation and validation activity for routine use.
• Investigation for laboratory event.
• Review and Approval of SOP, MOA, Specification.
• Planning of preventive maintenance and calibration activity of HPLC, GC and other laboratory instruments.
• Process validation study like Hold time study, Process Variable studies, Pre formulation study.
• Review of Drug Master file and vendor documents for API and Excipients.
• Vendor Audit and Vendor Approval for ongoing product development.

Analytical QA-

• Review and Approval of Laboratory investigation, OOS and OOT in commercial quality control department.
• Preparation and review of Plant documents like SOP, Vendor Audits document, Querry Response.
• Involved in new lab setup as per regulatory requirement include Instrument Procurement, Installation and Qualification as per Regulatory requirement.

Primary Responsibility:

• Planning and Execution of Management of Method validation, verification and Method transfer activity as per well defined timeframe for Injectables, Lyophilized and Injectable Oncology formulations.
• Daily work planning for RM, PM, FP, IP and Stability studies.
• Communication with R & D and other manufacturing sites for planning and execution of Method validation / Method transfer activity.
• Query response to regulatory authorities.  Routine area round to monitor the compliance and daily work activity.  Spreadsheets (Excel sheets) preparation and validation activity for routine use.

Additional Responsibility:

• Handling and review of Laboratory Incident, OOS and OOT using Track wise software.
• Planning of preventive maintenance and calibration activity of HPLC and GC laboratory.
• Review of Specification and Standard testing procedure.
• Routine QC related activities. Planning of Finished Product / Stability samples and In-process sample analysis.

Remarkable Contribution:

• Played an active role during USFDA inspection to fulfill GLP requirement.
• Successfully completed Excel calculation spreadsheet validation activity for spreadsheets according to EDQM guideline.
• Empower Assay and Related substances custom field preparation and validation for auto calculation to minimize manual calculation and to increase productivity.

• Analytical support for product development by performing analysis like Assay, RS, PSD, Dissolution profiling study, Multimedia dissolution study, Discriminating conditions of Dissolution, Intrinsic Dissolution study, excipient incompatibility study, Force degradation study.
• Trend analysis of developmental trials and development stability as per DoE.
• Similarity study for Development batches with RLD.
• Data sheet preparation, issuance and Report preparation using LIMS software.
• Standard management like procurement, storage, quantity management, working standard preparation.
• Outside testing study planning, management and compilation of results.
• Extensive routine and scheduled stability study of pharmaceutical dosage forms, to identify potential behavior at various stability time points as per ICH Q1 guidelines.
• Perform Dissolution development (DDR) for solid oral dosage form.

• Preparation and review of analytical documents – Protocol and Reports, Method of Analysis, Laboratory investigations attachment, SOPs.
• Instrument Installation and Qualification involved in Quality control department including Stability Chambers.
• Assay and RS method development for normal Injectables, Lyophilized formulations, Oncology injectable formulations.
• Excel sheet validations for Spreadsheet used in Routine and Validation study.
• Analytical support for product development by performing analysis on newly developed product.
• Literature search and Drug Master file review for new product method development.
• Preformed Pre formulation study like drug excipient compatibility study, Force degradation study.
• Product development and process validation studies like variable measurement, Hold time study, Tubing study,Filter compatibility study.
• Extensive routine and scheduled stability study of pharmaceutical dosage forms, to identify potential behavior at various stability time points as per ICH Q1 guidelines.

• Analytical method development of finish product formulations like Tablets, Capsules, Topical, Normal Injectable and Complex Injectable dosage forms.
• Method development of Assay, Related substances, Dissolution profile, Molecular weight, Particle size using Malvern master sizer, IVR study for Depot formulations, Inherent viscosity.
• Dissolution method development and preparation of DDR as per regulatory requirement.
• Dose dumping study, multimedia dissolution and biorelevant media dissolution study during product development.
• Reverse engineering for drug excipient identification and comparison of product in vivo performance.
• Polymer characterization study for microsphere and depot formulations.
• Pre validation study and report preparation.
• Instrument Trouble shooting for HPLC and Dissolution.
• Review, compilation and release of method developmental data to support Formulation development.
• Data archival of developmental data.
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• Method development and development of OSD, Topical and injectable formulations.
• Trained for QC Instrument installation and qualification for handling of projects all over the globe for QC Lab setup.
• Data compilation for stability studies and product development.
• Party audit and vendor audit for new facility setup.
• Product development report preparation as per regulatory requirements.
• Preparation of SOP, STP, MOA, Specification, Risk assessment.
• Performed Quality Control equipment installation and Qualification and Training given to the team of Tobinco Pharmaceuticals Ltd, Ghana, West Africa.