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How ready are you? Preparing for the impact of EU GMP Annex 1 on primary packaging

European Pharmaceutical Review

Indeed, a key aspect of EU GMP Annex 1 is the requirement for pharmaceutical manufacturers to develop a comprehensive Contamination Control Strategy (CCS) that documents their approach to assuring the sterile drug product’s high quality and, therefore, enhancing patient safety.

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Virtual and augmented reality: Bringing the future to pharma manufacturing

pharmaphorum

In this article, Ben Hargreaves asks whether there is particular potential for the technologies to revolutionise staff training and reduce costs in pharma manufacturing. the streamlining of pharma manufacturing in the 21st century. VR is an important element of Education 4.0, which is critical to Pharma 4.0,

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Basic cleaning and sanitation practices in Pharmaceuticals

GMPSOP

This article will explore the key considerations, best practices, and regulatory requirements for effective cleaning and sanitation that pharmaceutical companies must adhere to for optimal cleanliness and safety. We have categorized four types of sanitizing agents commonly used in pharmaceutical manufacturing.

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Pharmaceutical Procurement Strategies Overview

Viseven

Unexpected geographic factors Many pharmaceutical companies relying on global markets for drug materials are particularly vulnerable to shifting geopolitical situations. For instance, depending on sources in tariff-affected countries can substantially increase a pharma company’s operational expenses.

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An Annex 1 and Pharma 4.0 perspective on water quality

European Pharmaceutical Review

Annex 1 states that “at least one representative sample is included every day that the water is used for manufacturing processes” Another important aspect of grab sampling is the frequency, which is up to the pharmaceutical company to determine. Inspection Technical Guide – Water for Pharmaceutical Use.

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GMP cleaning and sanitation practices in pharmaceuticals

GMPSOP

This article will explore the key considerations, best practices, and regulatory requirements for effective cleaning and sanitation that pharmaceutical companies must adhere to for optimal cleanliness and safety. We have categorized four types of sanitizing agents commonly used in pharmaceutical manufacturing.

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Building CO2-neutral, defossilised supply chains for chemicals

European Pharmaceutical Review

2 However, most of these efforts relating to catalysis, 3 process waste metrics, 4 lifecycle assessments, 5 pharmaceuticals in the environment 6 and the phase out of substances of concern 7 mainly mitigate the consequences of pharmaceutical manufacturing. Defossilization of pharmaceutical manufacturing.