Vol. 40 | Vol. 40(2) - March / April 2022 | COLUMN: Quality & Supply Chain Security

The future of remote pharma GMP auditing

by 12 April 2022

A. Leckie 12 April 2022

EMA

GMP

life science

pharma

quality assurance

Remote Audit

ALASDAIR LECKIE
Rephine, Stevenage, Hertfordshire, United Kingdom

ABSTRACT

The COVID-19 pandemic saw pharma industry auditing move increasingly online and in place of on-site visits, we became familiar with virtual checks and inspections. Some auditors now say that virtual auditing could become a permanent solution, but deeper analysis shows that clients are not in favour of this option, says Alasdair Leckie, Operations Manager at Rephine Ltd.

There was a time that pharma regulators would never have considered the idea of remote audits to verify the manufacturing and distribution standards of supply-chain partners, but two years of pandemic have forced the industry to adapt.

ABOUT THE AUTHOR

Alasdair Leckie is Operations Manager at Rephine Ltd, a firm of deeply experienced GMP auditors which proactively helps pharmaceutical companies around the world with their supply-chain quality assurance. Alasdair has been with Rephine for nine years and has a Bachelor’s Degree in Chinese and Economics from SOAS, University of London.

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The future of remote pharma GMP auditing

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