Survey Report on Virtual FAT Conducted in Pharmaceutical Industry

A survey was conducted on Virtual FAT (Factory Test Acceptance) in this COVID-19 pandemic. This survey has got an eminent response from an Indian pharmaceutical organization. Many delegates from the different departments/professionals, such as Quality, Engineering, Production, Validations, and Consultants participated in it.

The survey focused on the understanding of Virtual FAT concepts from the Indian pharma Industry. People from different experiences participated actively in this survey. 49.1% of people responded that they had accepted the vFAT considering this COVID-19 pandemic. Meanwhile, 50.9% of people concluded that it is not successful. However, their views on this topic are mention below.

The survey reported with pros and cons of vFAT

Pros:

Cons:

Suggestions from the Participants:

Conclusion:

Due to this ongoing pandemic, we all had an unplanned Virtual FAT process enforced upon us. However, as a part of project, all FAT Testing procedure had to summarize in the FAT Report with detailed punch list, daily discussions and Virtual meetings.

Looking at the above pros and cons for Virtual FAT, and also the suggestion from the delegates. We can conclude that effective measures should be taken and any open points or remarks during virtual FAT should be clear and completed as per the compliance before dispatching or at the receiver/client site.

Considering above points with appropriate execution in a traceable manner, will have greater effect on leveragability in tests and this will lead to success of Virtual FAT. But ensure it shall have minimal dis assembling of machine while dispatching.

About the Author:

Mr. Varadharaj Vijayakumar is an experienced pharma professional, diligent in his core functional area (pharmaceutical technical operations) and committed to the profession.

His main area of expertise is aseptic processing & areas of interests are sterility assurance, manufacturing technology, process validation, failure investigations, troubleshooting, Isolator Technology Cycle developments, Risk assessments/QMS Gap assessments, Lyophilization, Glove Integrity testing’s.

He has been involved in many projects from concept design to successful delivery of commercial product to the continuous improvement phases and also led organization(s) efforts with teams in managing audits and validations aspects

He is a postgraduate in Pharmaceutical Sciences and an active member of professional associations like PDA, IPA, Lyophilization World. In addition to being a pharma-professional, he is also a regular speaker in webinar and a trainer on the topics like qualification and validations.

References:

ISPE Baseline Guide Vol 5: Commissioning & Qualification 2nd Edition.

EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary

Use Annex 15: Qualification and Validation

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