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What You Need to Know About GAMP® 5 Guide, 2nd Edition

WEBISPE’s GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition) (GAMP® 5 Guide, 2nd Edition) maintains the principles and framework …

Actived: 6 days ago

URL: https://ispe.org/pharmaceutical-engineering/january-february-2023/what-you-need-know-about-gampr-5-guide-2nd-edition

Engage with Health Authorities to Mitigate & Prevent Drug …

WEBWhen faced with large-scale disruptive events such as the COVID-19 pandemic, the emergency and business continuity plans of drug manufacturers and …

Category: Health Go Health

Software as a Medical Device Fundamentals Pharmaceutical

WEBSoftware 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, 2 Although SaMD …

Category: Medical Go Health

Live Biotherapeutic Products: Moving the Microbiome to the …

WEBLive biotherapeutic products (LBPs) have the potential to treat a wide range of ailments. However, these living microorganisms are difficult to produce due to …

Category: Health Go Health

2024 ISPE Annual Meeting & Expo ISPE International Society for

WEBOverview. The 2024 ISPE Annual Meeting & Expo is poised to herald a transformative era in pharmaceutical science and manufacturing. The increasing impact of new technology, …

Category: Health Go Health

Building Resilient and Sustainable Pharmaceutical Supply Chains

WEBThe global pharmaceutical industry has faced unprecedented challenges in recent years, with the COVID-19 pandemic serving as a wake-up call for the …

Category: Health Go Health

Unveiling the Green Prescription: Navigating Sustainability in the

WEBSustainability is emerging as a pivotal force influencing the pharmaceutical industry’s dynamics and steering companies towards transformative change. The focus …

Category: Health Go Health

Selection Criteria for Pharmaceutical Containment Equipment

WEBPharmaceutical manufacturing facilities produce a variety of products, including highly potent products that require safety measures to prevent adverse health …

Category: Health Go Health

Regulatory, Compliance and Quality Challenges, Learnings, and …

WEBThe pharmaceutical industry is constantly evolving, placing a significant emphasis on emerging technologies that facilitate quicker access of medications for …

Category: Health Go Health

Sustainability & the Life Sciences Industry: A Global Introduction

WEBIn this issue of Pharmaceutical Engineering®, we address an array of sustainability topics. This article surveys topics that will likely have a significant global …

Category: Health Go Health

Changing Lives with Gene Therapies Pharmaceutical Engineering

WEBThe process of bringing new drugs and products to market requires creativity, thinking outside the box, and the courage to fail numerous times before making a single …

Category: Health Go Health

Bowtie Analysis and Barrier-Based Risk Management

WEBThe bowtie enhances understanding of industry-specific scenarios and provides clear indication that the safeguards (risk-control measures) are in place and performing. It …

Category: Health Go Health

ICH Quality Guidelines: Present Initiatives & ISPE Involvement

WEBApproved Quality Guidelines. In the first decade, ICH teams worked on quality topics described in ICH Q1–Q6, working from a prioritized list (as given on the …

Category: Health Go Health

Cleaning Validation Program Maintenance in a Process Life-Cycle …

WEBThe process life-cycle model, as discussed in the US FDA guidance on process validation, is a significant change in how we view validation.1 The three-stage …

Category: Health Go Health

Personalized Medicine: The Industry’s Future

WEBThe future of true personalized medicine is the design and manufacture of one drug for one patient; 2 whether this is possible or sustainable for the pharmaceutical industry …

Category: Medicine Go Health

Health Canada on Advanced Manufacturing and Other Trends

WEBOn Wednesday, 18 October 2023, Dr. Celia Lourenco, Associate Assistant Deputy Minister of Health Canada's Health Products and Food branch, presented a …

Category: Food Go Health

Pharmaceutical Cleanroom Design & ISO 14644-16

WEBIn relation to ventilation efficiency, ISO 14644-16 specifies two types of ventilation efficiency: CRE and ACE. ACE is determined according to AN-SI/ASHRAE 129-1997, …

Category: Health Go Health

Evolving China’s Regulatory System in Alignment with ICH

WEBWith the Chinese government initiating drug regulatory reform in 2015 and China joining the International Council for Harmonisation (ICH) in 2017, a significant …

Category: Health Go Health

Automating MACO Calculations in Cleaning Validation

WEBThe CVLM program calculates MACO using four methods: health-based exposure limit (HBEL), therapeutic dose, toxicological, and 10-ppm approaches. …

Category: Health Go Health

Nandita Kamdar is a Director in the Engineering & Property …

WEBNandita Kamdar is a Director in the Engineering & Property Services (E&PS) Group at Johnson & Johnson in New Brunswick, NJ. She joined Johnson & Johnson in 2012.

Category: Health Go Health

ISPE NJ Newsletter

WEBprospective Young Professional members join us, along with a number of current YP members. This was a great networking event, at a pleasant, comfortable

Category: Health Go Health

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