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GMP programme for officers

Home GMP programme for officers and above

This training module shall be customized for API, Finished dosage forms, biotech, cosmetics, food, excipients and likes.

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GMP without worry and hurry – comprehensive course
  • Quality and GMP the relationship, history and evolution of Pharmaceutical Quality and GMPs, the needs and necessity of GMPs of US FDA, WHO, TGA ( PICS ), MHRA ( EU ) and ICH
  • Current Regulatory Trends and cGMP requirements; summary of changes to the GMPs till date for the agencies mentioned above and harmonization; the resources available to obtain GMP information.
  • Scope and applicability of GMP to include
  • Pharmaceutical quality systems and Risk Based Approach to cGMPs, overview of risk management tools and the five values of GMP - SISPQ ( E )
  • Locations and Surroundings, Buildings and Facilities, Factors that influence facility design and containment strategies with principles of HVAC systems.
  • Equipment procurement, qualification, validation, calibration, cleaning and maintenance.
  • Personnel ( education, experience ) hygiene sanitation, training requirements ( from need identification to sustenance ) and medical fitness.
  • Principles of Material management ( good storage practices and GMP principles from vendor management, stock management and rotation, issue and stock controls of components ).
  • Lab controls ( a very brief overview of good quality control lab practices - GQCLP )
  • Good documentation – Principles and Practices with emphasis on current requirements and the do's and don'ts.
  • Production ( principles of process validation, in-process controls, deviation management, change control and CAPA ) & Distribution controls ( market complaints and recalls ).
  • The risks of Contamination , Cross Contamination , Mix-Ups and Errors and their control measures.
  • Tips on facing GMP audits.
  • Maintaining the GMP continuum.

We provide GMP training as per requirements of the organization in the areas as under : WHO, TGA, MHRA, MCC, HPFB, US, FDA, EU, PICS & ICH

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For training enquiries, please contact us on
+91-20-25368620

Contact Us
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