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Basic Good Manufacturing Practices (GMP) by Sunil Singh

Description

This course is designed for learning/ understanding on Basic Good Manufacturing Practices (GMP) applicable for all Pharmaceutical professionals. GMP applies from product development till product delivered to the end user. There are multiple different activities involved e.g. Product development, technology transfer, material management, facility and equipment, production, analysis and dispatch. The GMP is mandatory to follow at each stage to ensure a consistent product quality each time and all the time.    

The course will start with a basic understanding on role of Pharmaceutical Industry, different functions/ departments, educational qualification required to work in different section of pharma industry along with current challenges. The next chapter will be the Regulations and Acts applicable to Pharma Industry related to GMP. The following chapters will be in a sequential manner from Organisation and personnel then Premises and Equipment required for producing the pharma product, Material management includes from vendor qualification to material dispensing, Product and process control followed by Quality control for analysis of material and product. The over and above, Pharmaceutical Quality System has been included to understand the management responsibility, quality manual, elements of GMP and brief on quality system requirement from product development to discontinuation.

Language: English

What Will I Learn?

  • Basic understanding of GMP
  • Material receipt to manufacturing
  • Pharmaceutical Quality System
  • Production and Control system
  • Challenges related to basic GMP system

Topics for this course

43 Lessons02h 58m

Overview

Know Your Educator1:51

Chapter 1: Introduction to Pharmaceutical Industry

Chapter 2: Regulation and Acts prevailing in Pharmaceutical Industry

Chapter 3: Organization and Personnel

Chapter 4: Pharmaceutical Quality System

Chapter 5: Premises and Equipment

Chapter 6: Material Management – Warehouse

Chapter 7: Production and Process Control – API/OSD

Chapter 8: Quality Control Laboratory

About the instructors

Sunil Singh has given 25 years of his life perfecting the art of upholding the highest possible standards of medicine quality. Graduating with M.Sc. in Organic Chemistry in 1994 from Banaras Hindu University (BHU), he has discharged numerous responsibilities during his career like handling of regulatory and customer audits, people development through training and demonstration, implementation and monitoring of Quality Systems based on FDA’s six quality systems approach, preparation of corporate guidelines for implementation across other sites in the organisation, monitoring the stability of API and DF, monitoring of Quality Systems through Quality Metrics as per new FDA/ MHRA guidelines and improving the productivity of QC labs by streamlining processes and removing bottlenecks in the system. He has been instrumental in the implementation of GMP/ Quality systems in compliance with guidelines/regulations like Schedule M, ICH Q7, USFDA, MCA, TGA, ANVISA, MCC, WHO, 21 CFR Part 210 & 211 etc. Handling of change control, Product complaints, response to regulatory audits, batch recall, CAPA, investigation, deviation management from set parameters/ regulations, OOS and Risk management. He has audited more than 75 plants that handle Drug Formulation, API, Intermediate and Packaging Material manufacturing. He has also handled Third Party manufacturing sites and ensuring timely batch release while making sure the required regulations are met. He has also effectively handled more than 50 inspections by reputed customers and regulatory agencies like USFDA, TGA, MCC, WHO, ANVISA, IMB, Ministry of Health (Russia) successfully. His core skills include Training and Development based on cGMP guidelines and regulations, Audit and compliance, Mentoring and Quality management system design and their effective implementation. Unflinching in resolve and surprisingly simple and logical in approach. He has started his career with Lupin and worked with organisations like Matrix Laboratories, Mylan Pharmaceuticals, Aurobindo Pharma, Ranbaxy, Sun Pharma, Dabur Pharma, Dr. Reddy’s Laboratories and Jubilant Generics.
5.00 (38 ratings)

14 Courses

1866 students

999.00

Material Includes

  • 8 Chapters
  • 42 Learning Videos
  • Course certificate

Requirements

  • Access with Laptop Mobile
  • Good internet connectivity

Target Audience

  • Any graduate
  • B Pharm M Pharm BSc MSc D Pharm
  • 12th Passout
  • Anyone working in QA QC and Production