Product Quality Lifecycle Implementation (PQLI)

iSpeak Blog

ISPE holds “Expert Xchange: Regulatory Summit on ICH Q9 Revision”

15 August 2022

“Are you ready to implement the updated ICH Q9(R1)?” That question was at the heart of the of ISPE’s “Expert Xchange: Regulatory Summit on ICH Q9 Revision” held 9 June 2022. Seventy-one participants from 14 countries discussed ICH Q9(R1) and received valuable insight from several members of the Expert Working Group (EWG) assembled in 2020 to lead the ICH Q9 revision process....

iSpeak Blog

Implementation of Patient Centric Specifications from an Industry & Regulator Perspective

8 November 2021

Over the past twenty years, an evolution of pharmaceutical development has resulted in new approaches to ensuring product quality and patient safety. The science and risk-based concepts outlined in ICH Q8-Q12 encourage a more holistic approach to the product control strategy. Under this paradigm, product quality should not be ensured by the quality specification, rather it should be confirmed....

iSpeak Blog

Transportable Manufacturing

13 September 2021

Imagine a time where medicines are made at your doorstep, where an illness can be treated in moments, storage conditions are a non-issue, quality is built in, and supply chains don’t matter. Your COVID-19 vaccine is manufactured, tested, and available for dosing, all within blocks of your home. Welcome to the age of transportable manufacturing.

Technical

Software as a Medical Device Fundamentals

1 July 2021

Software as a medical device (SaMD) is software intended to be used for one or more medical purposes without being part of a medical device.1

• 1International Medical Device Regulators Forum. “Software as a Medical Device (SaMD): Key Definitions.” 9 December 2013.

iSpeak Blog

ICH Q12 Implementation Strategies Discussed During Webinar on Challenges and Success of ICH Q12

1 March 2021

A technical working group under ISPE’s PQLI® Committee that is seeking to assist industry and regulators with implementation of ICH Q12 recently produced a webinar on

Features

Breaking with Tradition: Laying the Foundation for Validation 4.0

1 March 2021

A fundamental GMP requirement is that processes, systems, and methods used to produce medicines and treatments are validated, meaning their fitness for a purpose is demonstrated. If Industry 4.0 is to succeed in the pharma space as

Features

ICH Q12: A Transformational Product Life-Cycle Management Guideline

1 May 2020

On 20 November 2019, the ICH Assembly endorsed the Q12 guideline, “Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management,” at its biannual meeting in Singapore. This transformational guideline has a wide scope of applicability across pharmaceutical drug substances and products (both chemical and biological), drug-device combination products that meet the...

Technical

Evaluation of Visual Inspection in Parenteral Products

1 January 2020

According to US Pharmacopeia (USP) Chapter <790>, “all parenteral products should be essentially free from any visible particles.”1  This is the first and foremost requirement stated in all pharmacopeia for any injectable product. However, yielding absolutely particle-free...

• 1United States Pharmacopeia. USP Chapter <790>: Visible Particulates in Injections.

InTouch

Manufacturing & Control Challenges for Accelerated Development

1 November 2018

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