GMP Certification

It’s common, most of you are not aware of Goods Manufacturing Product. Therefore, today we will discuss some facts on Goods Manufacturing Product (GMP). It provides guidelines that ensure the food and pharmaceutical manufacturer maintains the minimum requirements in order to produce a high-quality product or not be risky for consumption. These guidelines are found in regulatory agencies working in the US, UK, China, Canada, and Europe, India etc. It is very important to maintain the quality of production and proportion of drugs because if these are ignored that can directly risk human life. GMP covers all parts of production starting from the raw materials, premises, the process of manufacturing and cleanliness of the staff working in the factories.

BENEFITS OF GMP CERTIFICATION

Each medication and clinical gadget maker keeps GMP guidelines and strategies while some have made their own rules that are in accordance with their regulation.

  • Empowering certification holders to opt for great creation,
  • Timely identification of manufacturers and management issues,
  • Compliance with important laws and guidelines,
  • Improving overall credibility and public image,
  • Reduce the safety risk in product quality and safety,
  • Increases consumer confidence in its products,
  • Helps reduce operating costs due to resale and penalties due to non-compliance,
  • Helps in promoting export opportunities,
  • Reduction in duplication of inspections
  • Money saving.
  • Benefits For The Producer
    One of the essential benefits is fundamentally worked on quality frameworks and quality consistence at the maker. We have seen these enhancements in the months paving the way to GMP certificate and have gone on during the years promptly following GMP confirmation.
  • Benefits For The Client
    Clients will normally change their checking to makers that have been GMP guaranteed. Clients know that to be ensured, the maker should have the framework set up and give proof that non-conformance and changes requiring client notice are dealt with appropriately.This confirmation is by and large not accomplished through the one-day provider reviews that pharma organizations perform; Rather, this certificate is accomplished because of an intensive, multi day review of the producer as a feature of the review program.

Documents for GMP Certification

  • Applicant name with address, telephone, fax, e-mail etc.
  • Manufacturing License Copy  .
  • Approved products List.
  • Site Master file (as specified under WHO TRS 823).
  • Data on Finished Formulation:-
    1. Manufacturing process & formula.
    2. Final product specification and Method of Analysis.
    3. Study evaluation report (Accelerated & Real Time) for 3 batches including details –  batch size, Batch No., Date of manufacturing, Date of Expiry, 
  • 4. Process validation report for 3 batches.
  • 5.Analysis  method report .
  • List of technical staff, with their qualification, experience.
  • List of equipment and instrument.
  • List of SOPs and STPs.
  • Manufacturing Plant layout plan .
  • Schematic plan  of water system specifying circulation loop and MOC.
  • Product summary sheet (as per Format B).
  • Proof of safety and effectiveness as per Rule 158B of Drugs & Cosmetic Rules, 1945.
  • Undertaking regarding compliance to the provisions of domestic regulations inter-alia The Drugs & Cosmetics Act, 1940 and Rules under, The Drugs & Magic Remedies (Objectionable Advertisements) Act, 1954 and Rules there under, etc.

FAQ

Application for GMP certification must be made by an approved person within the organization seeking confirmation. This is usually one with an obligation to, for example, a production manager, a quality assurance manager, a quality control manager or a managing director.

Application for GMP certification must be made by an approved person within the organization seeking confirmation. This is usually one with an obligation to, for example, a production manager, a quality assurance manager, a quality control manager or a managing director.

The CE marking indicates that the manufacturer assumes responsibility for product compliance with all relevant European health, safety, performance and environmental requirements.

CE marking enables a person to legally sell their product in the European market and declare that your product complies with the relevant European Directives and Regulations

FDA approval means that the device is approved for use in all parts of the world, while there are restrictions on the CE mark, sometimes even within the European Union. ... It is also possible that the FDA's strictures are considered safe for consumers.

Good quality can be assured during the manufacturing process, it is not possible to test it later. GMP protects the final product from errors that cannot be ignored through a quality product. Without GMP it is difficult to be certain that each unit of the drug is of the same quality as the units of the drug tested in the research facility

There are many benefits of GMP certification which are there for the manufacturers as well as the customers, which are as follows:-

  • Empower delegates to choose great creations
  • Identify manufacturing and management issues
  • Compliance with laws and guidelines
  • Increase credibility and public image
  • Reduce safety risks in product quality and safety
  • Increases consumer confidence in your products
  • Helps reduce operating costs due to resale and penalties due to non-compliance
  • Help Boost export Opportunities
  • Reduced duplication of inquiry
  • Cost saving

The primary objective of GMP is to reliably deliver great medicines or clinical gadgets that meet the global guidelines required for pharmaceutical services. The processes used in manufacturing are deliberately controlled, and any progress in the process must be evaluated.

The certification is generally valid for a time period of three years.

The purpose of inspecting pharmaceutical manufacturing offices is to either enforce the Good Manufacturing Practices (GMP) continuum or to approve the manufacture of explicit pharmaceutical goods, which is usually consistent with an application for marketing approval.

Unapproved quality drugs not only pose health hazards but also lead to misappropriation of cash for the two governments and individual buyers. GMP is designed to guarantee that mistakes do not happen. The execution of GMP is interested in good quality medicines.

cGMP refers to the 'Current Good Manufacturing Practice' guidelines authorized by the US Food and Drug Administration (FDA).

 

'Good Manufacturing Practices' (GMP) is a framework to guarantee that goods are reliably delivered and controlled by quality guidelines.

GMP certification is a quality assurance system that ensures that pharmaceutical, medical device, and food products are consistently produced and controlled according to the highest quality standards.

GMP certification is important as it ensures that products are safe, effective, and of high quality. It also helps to protect consumers from potentially harmful products and supports global trade by ensuring that products meet internationally recognized standards.

GMP certification is required for industries that produce pharmaceuticals, medical devices, and food products, among others. It is also required for manufacturers of active pharmaceutical ingredients (APIs) and excipients.

To obtain GMP certification, you must first ensure that your product and manufacturing processes meet the relevant GMP standards. You must then undergo an audit by a certification body that is accredited to assess compliance with GMP standards. If you meet the standards, you will be issued a GMP certificate.

The time it takes to obtain GMP certification varies depending on the product and the complexity of the certification process. It can take anywhere from several months to over a year to obtain GMP certification.

A certification body is an independent organization that assesses compliance with GMP standards and issues GMP certificates.

GMP certification offers many benefits, including improved product quality, increased customer confidence, enhanced reputation, and access to global markets.

GMP standards are a set of guidelines and regulations that ensure that products are produced and controlled according to the highest quality standards. The standards cover areas such as quality control, manufacturing processes, personnel, facilities, and equipment.

GMP certification is recognized internationally and can be transferred to other countries, provided that the certification body is accredited by an internationally recognized accreditation body.

The cost of obtaining GMP certification varies depending on the product and the complexity of the certification process. It typically involves audit fees, application fees, and fees for the services of the certification body.

Get a Call Back

Blog

Our Latest News

  • All|
  • Income Tax|
  • Trademark Registration|

Testimonials

Our Address

431, Ground floor Kakrola, Dwarka Mor, Dwarka, Delhi, 110075

Phone Number

+91 88821-64038

E-mail Address

support@legalstartup.in

Legalstartup is a part of online legaltaxation India service pvt ltd. Which is registered under the Companies Act, 2013, recognized by the Govt. of India.
Disclaimer :
• This is not a Government run Website and the form is not the actual registration form, it is just to collect information from our clients so that our expert can easily understand their business or needs. By proceeding forward with this website you are aware that we are a private company managing this website and providing assistance based on the request from our customers and the fee collected in this website is a consultancy fee.

Copyright 2019 – 2023 legalstartup.