JoonLeong Ng

With 15 years of experience across the APAC region with a focus on Commissioning, Qualification & Validation in the pharmaceutical industry, Joon has gathered extensive hands-on as well as management experience. He also possesses in-depth knowledge in Regulation & Guidelines, Project Management, Change Control Process, and Lean Leadership.

commissioning and qualification debunking the myths nodeviation

Commissioning and Qualification in the pharma industry: debunking the 5 myths

Over the years that I have been working, starting as a junior C&Q engineer, there has been an increasingly blurred line between Commissioning and Qualification that at times, it is difficult for my counterparts in the construction management team (CMT) to exactly understand the division (or integration) of tasks between the CMT and the CQV…

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what is paperless validation in-the-pharmaceutical industry nodeviation

What is paperless validation in the pharmaceutical industry

Before diving into the topic of paperless validation in the pharmaceutical industry, the fundamentals of Good Documentation Practice (GDP) shall be reiterated. Data integrity, arguably the most discussed topic, is the bedrock of GDP in any form of record – paper or electronic. ALCOA+ (a mnemonic) is a set of principles that ensures data integrity.

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No deviation and PlantQuest partner to track critical equipment in large scale pharma manufacturing and industrial facilities

No deviation and PlantQuest partner to track critical equipment in large-scale pharma manufacturing and industrial facilities

No deviation, a patient-centric solution provider for the pharmaceutical industry is pleased to announce its partnership with PlantQuest, a software company headquartered in Waterford, Ireland, offering data-driven location solutions for asset-intensive facilities. This partnership will enable pharmaceutical companies with large process facilities to navigate and find fixed assets faster, through a bespoke digital map, which

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a guide to iq oq and pq in the pharmaceutical industry no deviation

A guide to IQ, OQ, and PQ in the pharmaceutical industry

The following information presented is based on the author’s interpretation and understanding of the EudraLex Volume 4 Annex 15 – Qualification and Validation, specifically on the topic of qualification stages for equipment. The scope of the blog post is on Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ). The definition of each of

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