Sneha Madurwar

Formulation and Development Documentation

· Handling of SAP [System Analysis Program] i.e. Preparation of Product master, Bill of Material, Preparation material master, Allocate new product code

· Handling of Quality Management System (QMS) i.e., change control, Deviation, CAPA, and documentation.

· Handling of Document Management System (DMS) i.e., uploading Document in system

· Preparation and review Product Development Report (PDR)

· Review document i.e., Formulation Sheet, Master Formula Card, Raw Material Specification, Packing Specification, Finished Product Specification, Manufacturing License, Stability data, COA and Product Executed Documents

· Preparation, Review, and approval of Standard Operating Procedures.

· Work as per quality systems with strict adherence to quality documents (SOP/MFC/Formulation sheet/BOM)

· Prepare and monitor daily, a weekly and monthly report of the department

· Software handling [QAMS (Change control), DMS (Document Upload), SAP (preparation of Bill of Material)].

a. Preparation of Bill of Material in SAP

b. Change Control Activity in QAMS

c. Preparation SOP and uploading documents in DMS.

Formulation and Development

· Preparation of documents like Compatibility study protocol and stability testing protocols, pre-formulation protocol, along with technical document like Master Formula Card (MFC), Formulation sheet, Master Packing Card (MPC), Batch Manufacturing Record (BMR), Product Development Report (PDR), Stability report critical process parameter, Tentative finished product specification and In process specification etc.

· Preparation of strategy document, feasibility report, material budget, license

· Compilation of trial batch with result

· Preparation of Monthly Report

· Generation of Bulk Product Code, Batch Prefix, Raw material code & code for general material.

· Format issuance

Literature survey

· Carried out literature search, typical patent searches with specialized databases (Orange book) and data compilation for preparation of strategy document of assigned product.

· Evaluation of physical and physicochemical properties of drugs to illustrate their influence on the stability of the intended formulation, and drug release characteristics that includes decision of excipients and tests depending upon the product to be developed.

· Conducted stability studies of API’s and drug product as per ICH guidelines,

· Study of product behavior and dissolution profiles in different storage conditions.

Process - Equipment/Machines Lab, Pilot scale

Granulation - Rapid mixture granulator

Compression - Single rotary tablet compression machines

Double rotary compression machine

Blending/mixing - Square bin blender, double cone blender

Milling - Multi mill

Compaction - Roller compacter

Tablet Coating - Pan coater

Capsule Filling - Manual capsule filling machine

Packaging - Alu/Alu blister packing machine

Inter department correspondence

· Continuous follow up with various departments like analytical method development, regulatory cell, marketing, purchase and stores.

· New vendor development for excipients.

· Coordinating activities with various departments involved in products development like Raw materials procurement, Tooling procurement and Stability monitoring.

Formulation and Development

9 Month working experience as research project trainee in Formulation Research Development, Academic Research Project [M. Pharm]: “Formulation and Development of immediate release tablet of diuretic drug by using Quality By Design approach.”