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Good Manufacturing Practice (GMP)

Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control authorization and licensing for manufacture and sale of food, drug products, and active pharmaceutical products. These guidelines provide minimum requirements that a pharmaceutical or a food product manufacturer must meet to assure that the products are of high quality and do not pose any risk to the consumer or public.

Why this course ?

covers international requirements and standards set by regulatory bodies and provides official certificate of achievement. It is suitable for anyone involved in manufacturing of medicinal products for human and veterinary use and also for all individuals that need official certification in GMP.


Course Features

  • Instructor Live Sessions

    There will be allocated hours of instructor with Live classroom and Simultaneously on Online.
  • Real Time Studies

    Live project based on any of the selected use cases on the above selected Domain.
  • Assignments

    Each class will be followed by practical assignments which can be completed before the next class. 
  • 24/7 Support

    We have 24x7 support team available to help you with any technical queries you may have during the course and after completion of the course with in a year.
  • Certification

    Towards the end of the course, you will be working on a project. Covalent certifies you as an course Expert based on the project.

Course Curriculum

Download
  • Good Manufacturing Practice (GMP)

    Introduction

    Overview

    Learning objectives

    Who should take this course?

    Module overview

     

    Module 1: The Starting Line

    Overview

    What is GMP?

    What is cGMP?

    World Health Organization (WHO)

    Why GMP?

    Module 2: Cases From History

    Overview

    Cases from history

    1930 – Lubeck – BCG Vaccine

    1938 – Sulphanilamide

    1940 – Contaminated Caps – Lambert

    1955 – Polio Vaccine

    1962 – Thalidomide

    Why GMP is so Important?

    Module 3: GMP Regulations

    Overview

    GMP Regulations & Guidelines

    GMP's in Different Countries

    WHO

    ICH

    EMEA

    MHRA

    USFDA

    GMP concept

    What aspects of manufacturing does cGMP cover?

    Review activity

    Module 4: Quality Management System (QMS)

    Overview

    What is Quality Management?

    Standard Operating Procedures (SOP)

    Quality Objective

    GMP as a part of Quality Assurance

    Requirements for an effective QA program

    ICH Q10

    Life Cycle Phases of GMP

    Module 5: Premises

    Overview

    Premises

    Production Areas

    Changing Rooms

    Storage Areas

    Quality Control Areas

    Module 6: Personnel

    Overview

    Personnel

    General Principles

    Staff Product Contact Requirements

    Grades A,B,C & D

    Personal Hygiene

    General considerations for manufacturing areas

    Review activity

    Module 7: Changes to Equipment

    Overview

    Equipment

    Balances

    Utilities

    Documentation

    Change control

    Module 8: Qualification & Validation

    Overview

    Definitions

    Qualification Vs Validation

    Risk Assessment

    Types of Validation Documentation

    Module 9: Complaints and Product Recalls

    Overview

    Complaints and product recalls

    Classification of defects – critical

    Classification of defects – major

    Classification of defects – minor

    Product recall procedures

    Module 10: Self-Inspection

    Overview

    Self-inspection

    Frequency

    Self inspection team

    Self Inspection approach – systems

    Self inspection approach – areas

    Review activity

    Module 11: Production Practices

    Overview

    Good Practices in Production

    Prevention of Cross Contamination

    Module 12: Quality Control

    Overview

    Quality Control

    Sampling

    Documentation

    Stability Programme

    Quality Testing

    Moving forward

     

Projects

  • GMP Real Time Project

    Realtime Projects or Practicals on:-

    Quality Systems
    Facilities and Equipment Systems
    Materials Systems
    Production Systems
    Packaging and Labeling Systems
    Laboratory Control Systems

FAQ's

  • Can I attend a demo session before enrollment?

    Yes

  • What if I miss a class ?

     If you miss a class we can provide recording video for particular session or we can arrange you the back up session. 

  • Will I get placement Assistance ?

    Yes

  • Do I receive a certificate for training ?

    Yes

  • What support is available after the training?

    Doubts clarification up to getting a job

    Resume preparation

    Malk interviews

    Placement Assistance

  • What Features do you provide?

    Class Room & Online Live sessions
    Real-time projects
    Working faculties 
    Placement assistance
    Resume preparation
    Doubts Clarifications

Certifications

  • Certificate/Certification

    Covalent provides training certificate after completion of the course. 

Videos

Good Manufacturing Practice Demo

Reviews

Prabhanjan

Fresher

I thought it would be hard to find a good institute for this course. Thank God, Covalent did an excellent job by providing valuable training in Good Manufacturing Practice (GMP). I strongly suggest this institute.

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Ravi Kiran Kolisetty

Production Chemist

Joshi

GMP Associates

Excellent realtime training on GMP. I got a very clear understanding and confidence after the course, I strongly recommend Covalent Trainings.

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RESHMA SHAIK

Fresher

I am very glad to be a part of this institute...such an encouraging and helpful to getting jobs always...Thanks a lot for everything.

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