Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation)

  • 1699.00 Dollar US$
  • Published date: November 28, 2020
    • san Jose, california, United States

The Process Validation Guidelines (January 2011) and the EU Annex 15: Qualification and Validation (October 2015) outline the general principles and approaches the two regulatory bodies consider appropriate elements of process validation for the manufacture of human and animal drugs and biological products, including Active Pharmaceutical Ingredients (APIs). These guidances align Process Validation activities with a product lifecycle concept and with existing FDA and EU guidances, including the FDA/International Conference on Harmonization (ICH), Guidance for Industry, Q8 (R2) Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System. The lifecycle concept, new to these Guidances, link product and process development, qualification of the commercial manufacturing process, and maintenance of the process in a state of control during routine commercial production. These guidances also support process improvement and innovation through sound science and risk management. The new Process Validation Guideline/Practice incorporate elements of Process Validation as early as the Research and Development phase, and continues onward through Technology Transfer, into the Phase 1 IND Clinical Trial manufacturing phase, and ultimately into Phase 2 and 3, and then commercial manufacturing.

Result 0 votes
Ashutos Swain
0 votes

Useful information

  • Avoid scams by acting locally or paying with PayPal
  • Never pay with Western Union, Moneygram or other anonymous payment services
  • Don't buy or sell outside of your country. Don't accept cashier cheques from outside your country
  • This site is never involved in any transaction, and does not handle payments, shipping, guarantee transactions, provide escrow services, or offer "buyer protection" or "seller certification"

Related listings

  • ANDA Submission and GDUFA Guidance

    ANDA Submission and GDUFA Guidance

    Drug Development Palo Alto (California) September 22, 2020 329.00 Dollar US$

    In order to properly, effectively, and efficiently bring generic drugs and medicinal products to market, it is crucial to anyone interacting with the submittal process to understand how the process is structured and functions

  • Medical Claims Boot Camp

    Medical Claims Boot Camp

    Drug Development Fremont (California) August 7, 2020 545.00 Dollar US$

    This course covers the fundamentals of medical billing, coding, and reimbursement by explaining how all of these components work together. Emphasis will be placed on the practical application of the latest industry knowledge and standards, with the g...

  • Fraud & Abuse, Stark & Anti-Kickback Issues

    Fraud & Abuse, Stark & Anti-Kickback Issues

    Drug Development Fremont (California) December 4, 2019 139.00 Dollar US$

    Overview: The presentation will provide an overview of the Federal Stark and Anti-Kickback laws and corresponding regulations including the history and purpose of these laws. The presenter will provide the background upon which these laws were determ...