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How to Design Aseptic Manufacturing for Best Compliance

Ashwani Tripathi July 6, 2020 267


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The manufacturing of sterile drugs is a critical and essential process. For the process to conform to the strict GMP requirement, it is crucial to design every aspect of the manufacturing with high quality in mind.

In this episode, Ashwani Tripath, head of compliance at Alembic Pharmaceuticals, explains what’s important to take into consideration when designing new aseptic manufacturing.

Here are some of the things you will learn from watching or listening to the episode:

  • How to design a cleanroom
  • Risk assessment for newly designed cleanrooms
  • How to deal with unexpected deviations in a project
  • What to keep in mind when you choose cleanroom equipment
  • What Is the Most Complicated Equipment to Qualify
  • What is the most complicated equipment to qualify
  • How to avoid contamination by personnel

 

 

 

 

Are you tired of wasting time and energy on repeating deviations?

Then, join us at our upcoming master class and learn how to save time and money by reducing repeating deviations.

You will master the essential elements for investigating deviations that arise during the product life cycle of medicinal products and learn how to document and address deviations much more effectively.

At the end of the 2-day session, you will know how to reduce the reoccurrence of deviations in your organization and minimize overdue issues in the QMS.

As a result, you will boost your compliance, improve KPI, and save much time and money in the process.

Besides, fewer deviations mean less stress at the workplace and a much healthier business environment.

Download now: How to Design Aseptic Manufacturing for Best Compliance

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Ashwani Tripathi

Ashwani Tripathi is the audits and compliance lead at Alembic Pharmaceuticals Ltd. He has performed more than 100 international GMP quality audits throughout his career. Ashwani has gained his expertise working in top pharma companies in India, such as Ranbaxy Laboratories, Cipla, Lupin, Ipca Pharmaceutical, and Torrent pharmaceutical.

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