Everand Logo

Welcome to Everand!

  • Discover millions of ebooks, audiobooks, and so much more with a free trial

    Only $11.99/month after trial. Cancel anytime.

    Good Manufacturing Practices (GMP) Modules for Pharmaceutical Products
    Good Manufacturing Practices (GMP) Modules for Pharmaceutical Products
    Good Manufacturing Practices (GMP) Modules for Pharmaceutical Products
    Ebook84 pages1 hour

    Good Manufacturing Practices (GMP) Modules for Pharmaceutical Products

    By Chandrasekhar Panda

    ()

    Read preview

    About this ebook

    This Book contains 11 Modules of Good Manufacturing Practices (GMP) for Pharmaceutical Products which will be very useful to the persons working in Pharmaceutical Industry and this can be used as a cGMP Training modules in Pharmaceutical Companies which is a basic training requirement for every employee. The Modules are Module-1 Plant Premises Module-2 Plant Equipment's Module-3 Plant Production Module-4 Plant Personnel Module-5 Plant Training, Documentation and Personnel Hygiene Module-6 Plant Quality Control Module-7 Qualification and Validation Module-8 Pharmaceutical QMS Module-9 Plant Self-Inspection and Audit Module-10 Plant Complaints and Product recall Module-11 Plant Contract Manufacturing and Contract Analysis

    LanguageEnglish
    PublisherPencil
    Release dateJun 24, 2021
    ISBN9789354583049
    Good Manufacturing Practices (GMP) Modules for Pharmaceutical Products

    Related to Good Manufacturing Practices (GMP) Modules for Pharmaceutical Products

    Related ebooks

    Social Science For You

    View More
    View More

    Related podcast episodes

    Related articles

    • Article

      Packaging with Potential

      Sep 27, 2019

      Packaging with Potential
      2 min read

    • Article

      Indian Pharma's Big Leap

      Apr 30, 2018

      Indian Pharma's Big Leap
      6 min read

    • Article

      Integrated Pest Management For Cannabis

      Mar 18, 2022

      It is of the utmost importance for the commercial cannabis producer to ensure the success of each crop cycle. This is particularly the case when cannabis is being grown for medical uses, as the cost of production is very high, due to factors such as

      2 min read

    • Article

      The Biohazard Necessities

      Aug 23, 2018

      There are an estimated 16 billion injections administered globally each year, and not all of the used syringes and needles end up properly disposed of, creating risks of injury and infection, as well as opportunities for reuse, according to the World

      4 min read

    • Article

      The Importance Of Quality Control In Cannabis Cultivation

      Apr 21, 2023

      Cannabis cultivation is a complex process that involves seed selection, cloning, propagation, development, harvesting and curing. Quality control is needed at every step of the process. Quality control ensures that the cannabis product is clear of pe

      2 min read

    • Article

      Standard Operating Procedures In Cannabis Production

      Jul 22, 2022

      In cannabis production, standard operating procedures (SOPs) form the backbone of operations and compliance, especially when it comes to medical cannabis cultivation. SOPs are essentially a set of best practices and standards that detail the daily op

      2 min read

    • Article

      Compliance and Cultivation

      Jun 24, 2021

      Compliance and Cultivation
      2 min read

    • Article

      The Best Infection Prevention Products 2021

      Jul 9, 2021

      Newsweek, IN PARTNERSHIP WITH THE LEAPFROG GROUP, an independent nonprofit that evaluates health care quality, compiles and publishes an ongoing series of ratings for health care facilities and products. We make selections and ratings using publicly

      8 min read

    • Article

      Cultivating the Right Climate

      May 30, 2018

      Growing cannabis is becoming increasingly mainstream as more states legalize it for medical and adult use. Cultivators are moving out of the black and gray markets and setting up fully legal, commercial cultivation facilities. The move into legitimac

      1 min read

    • Article

      What Is Ethical Manufacturing And Why Is It So Important?

      Sep 10, 2021

      Businesses have a big impact on their community, whether that involves how they care for the environment or how they contribute to the lives of their staff. This is particularly true for manufacturers. Their presence is vital in supporting communitie

      3 min read

    • Article

      Cannabis Production Starts With Healthy Plants

      Apr 12, 2024

      The importance of integrated pest management, good-quality, disease-free plant material and compliance with market standards were highlighted at the Cheeba Cannabis Cultivation Summit recently held at the Cape Town International Convention Centre (CT

      2 min read

    • Article

      Building Immunity

      Dec 31, 2021

      Building Immunity
      3 min read

    • Article

      How SA Regulates Medicines And Vaccines

      Feb 13, 2021

      COVID-19 has raised public awareness about the role of national medicines regulatory authorities in enabling access to safe, effective and quality-assured medicines. This includes vaccines. In South Africa, the pandemic has also exposed several impor

      4 min read

    • Article

      How SA Regulates Medicines And Vaccines

      Feb 13, 2021

      COVID-19 has raised public awareness about the role of national medicines regulatory authorities in enabling access to safe, effective and quality-assured medicines. This includes vaccines. In South Africa, the pandemic has also exposed several impor

      4 min read

    • Article

      Closed For Cleaning

      Jul 3, 2020

      Closed For Cleaning
      4 min read

    • Article

      Better by Design

      Dec 31, 2023

      Better by Design
      4 min read

    • Article

      How SA Regulates Medicines And Vaccines

      Feb 13, 2021

      COVID-19 has raised public awareness about the role of national medicines regulatory authorities in enabling access to safe, effective and quality-assured medicines. This includes vaccines. In South Africa, the pandemic has also exposed several impor

      4 min read

    • Article

      Questions To Consider Before Starting In Cannabis Extraction

      Feb 12, 2021

      Separations (separations.co.za) is a South African company that supplies the pharmaceutical and cannabis industries with testing and extraction equipment. I recently asked Jeff Verlinden, a sales representative at the company, about the main processe

      2 min read

    • Article

      Controlling Pests And Diseases In Cannabis Cultivation

      Feb 17, 2023

      In this article, I would like to focus on a number of recent advancements in pest and disease management that are readily available to today's commercial cannabis producer. These include updates of triedand-tested techniques, as well as high-tech equ

      2 min read

    • Article

      Choosing A Suitable Site For Your Cannabis Operation

      Nov 19, 2021

      Greenhouses or indoor cultivation, along with their respective technologies, make it theoretically possible today to produce cannabis in any environment, including in regions that experience extreme humidity, temperatures and rainfall. But the cost o

      1 min read

    Related categories

    Reviews for Good Manufacturing Practices (GMP) Modules for Pharmaceutical Products

    0 ratings

    0 ratings0 reviews

    What did you think?

    Tap to rate

    Review must be at least 10 words

      Book preview

      Good Manufacturing Practices (GMP) Modules for Pharmaceutical Products - Chandrasekhar Panda

      Good Manufacturing Practices (GMP) Modules for Pharmaceutical Products

      Good Manufacturing Practices (GMP) Modules for Pharmaceutical Products

      BY

      Chandrasekhar Panda

      pencil-logo

      ISBN 9789354583049

      © Chandrasekhar Panda 2021

      Published in India 2021 by Pencil

      A brand of

      One Point Six Technologies Pvt. Ltd.

      123, Building J2, Shram Seva Premises,

      Wadala Truck Terminal, Wadala (E)

      Mumbai 400037, Maharashtra, INDIA

      E connect@thepencilapp.com

      W www.thepencilapp.com

      All rights reserved worldwide

      No part of this publication may be reproduced, stored in or introduced into a retrieval system, or transmitted, in any form, or by any means (electronic, mechanical, photocopying, recording or otherwise), without the prior written permission of the Publisher. Any person who commits an unauthorized act in relation to this publication can be liable to criminal prosecution and civil claims for damages.

      DISCLAIMER: The opinions expressed in this book are those of the authors and do not purport to reflect the views of the Publisher.

      Author biography

      The author of this Topic is Chandrasekhar panda who is having more than 14 years of Experience in Pharmaceutical Quality Assurance department and he has worked in Pharma Companies like Cipla, USV & Aurobindo Pharma Limited.

      Contents

      Good Manufacturing Practices (GMP) Modules for Pharmaceutical Products

      Good Manufacturing Practices (GMP) Modules for Pharmaceutical Products

      What is Good Manufacturing practices (GMP) :

      Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.

      The main risks are:

      Unexpected contamination of products, causing damage to health or even death; incorrect labels on containers, which could mean that patients receive the wrong medicine; insufficient or too much active ingredient, resulting in ineffective treatment or adverse effects.

      GMP covers all aspects of production; from the starting materials, premises and equipment to the training and personal hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process - every time a product is made.

      What is Current Good Manufacturing practices (cGMP) :

      The letter c stands for current, reminding manufacturers that they must employ technologies and systems that are up-to-date in order to comply with the regulation.

      Can Manufacturers afford to implement GMP:

      Yes. Making poor quality products does not save money. In the long run, it is more expensive finding mistakes after they have been made than preventing them in the first place. GMP is designed to ensure that mistakes do not occur. Implementation of GMP is an investment in good quality medicines. This will improve the health of the individual patient and the community, as well as benefiting the pharmaceutical industry and health professionals. Making and distributing poor quality medicines leads to loss of credibility for everyone: both public and private health care and the manufacturer.

      There are various Modules of GMP which are required for Pharmaceutical products which includes GMP for plant premises, Equipment's, Production, Training, personnel Hygiene, Qualification & Validation, Quality Management system, Self-Inspection, quality audits and suppliers’ audit, Personnel, Quality Control, and Complaints & Recall.

      Module-1 Pharmaceutical  Plant Premises Requirement as Per GMP

      Below given details are the GMP requirements for the Pharmaceutical Plant premises or campus and Premises or campus must be located, designed, constructed, adapted and maintained to afford the Operations to be carried out.

      General Requirements :

      The layout and design of premises must aim to minimize the risk of errors and permit effective cleaning and maintenance in order to avoid cross contamination, build-up of dust or dirt, and in general, any adverse effect on the quality of products.

      Where dust is generated (e.g. during sifting, weighing, mixing and processing operations, or packaging of powder), measures should be taken to avoid cross-contamination and facilitate cleaning.

      Premises used for the manufacture of finished products should be suitably designed and constructed to facilitate good sanitation.

      Premises should be carefully maintained, and it should be ensured that repair and maintenance operations do not present any hazard to the quality of products.

      Premises should be cleaned and, where applicable, disinfected according to detailed written procedures and records should be maintained.

      Electrical supply, lighting, temperature, humidity and ventilation should be appropriate and such that they do not adversely affect, directly or indirectly, either the pharmaceutical products during their manufacture and storage, or the accurate functioning of equipment.

      Premises should be designed and equipped so as to afford maximum protection against the entry of insects, birds or other animals. There should be a procedure for rodent and pest control. Premises should be designed to ensure the logical flow of materials and personnel movement.

      Additional Areas :

      Rest and refreshment rooms should be separate from manufacturing and control areas.

      Facilities for changing and storing clothes and for washing and toilet purposes should be easily accessible and appropriate for the number of users and Toilets should not communicate directly with production or storage areas.

      Maintenance workshops should if possible be separated from production areas. Whenever parts and tools

      Enjoying the preview?
      Page 1 of 1