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Month: January 2019

The Unique Challenges Facing Cannabis-based Pharma
Health

The Unique Challenges Facing Cannabis-based Pharma

Posted on January 30, 2019 by admin

In June 2018, the FDA approved the first-ever pharmaceutical derived from the cannabis plant, Epidiolex (cannabidiol, CBD). GW Pharmaceuticals’ lead therapeutic reduces the frequency of…

‘The goal is to automate us’: welcome to the age of surveillance capitalism
Economics

‘The goal is to automate us’: welcome to the age of surveillance capitalism

Posted on January 30, 2019 by admin

Shoshana Zuboff’s new book is a chilling exposé of the business model that underpins the digital world. Observer tech columnist John Naughton explains the importance…

WHO Guidelines – Qualification of temperature-controlled storage areas – Free PDF download
Pharmaceutical

WHO Guidelines – Qualification of temperature-controlled storage areas – Free PDF download

Posted on January 30, 2019 by admin

Technical supplement to WHO Technical Report Series, No. 961, 2011 Annex 9: Model guidance for the storage and transport of time and temperature–sensitive  Pharmaceutical products What is…

WHO guidelines – Temperature and humidity monitoring systems for fixed storage areas – Free PDF download
Pharmaceutical

WHO guidelines – Temperature and humidity monitoring systems for fixed storage areas – Free PDF download

Posted on January 30, 2019 by admin

Technical supplement to WHO Technical Report Series, No. 961, 2011 Annex 9: Model guidance for the storage and transport of time and temperature–sensitive pharmaceutical products This technical supplement…

WHO Guidelines: Temperature mapping of storage areas – free PDF download
Pharmaceutical

WHO Guidelines: Temperature mapping of storage areas – free PDF download

Posted on January 30, 2019 by admin

This technical supplement has been written to amplify the recommendations given in section 4.7 of WHO Technical Report Series No. 961, 2011, Annex 9: Model guidance for…

Introduction to Temperature Mapping of Controlled Temperature Storage Areas – Temperature Mapping  – Free PDF Download
Pharmaceutical

Introduction to Temperature Mapping of Controlled Temperature Storage Areas – Temperature Mapping – Free PDF Download

Posted on January 30, 2019 by admin

Temperature mapping establishes the temperature distribution within the zone being mapped and it locates hot and cold spots. A temperature mapping exercise is required for any space…

GMP Warehouse Mapping – Step-by-Step Guidelines for Validating Life Science Storage Facilities – Free PDF download
Pharmaceutical

GMP Warehouse Mapping – Step-by-Step Guidelines for Validating Life Science Storage Facilities – Free PDF download

Posted on January 28, 2019 by admin

Good manufacturing practice (GMP) regulators in the United States, Canada, European Union, Japan, Australia, and China have sharpened their focus on warehouse storage and distribution practices. Driving this…

General Principles of Software Validation; Final Guidance for Industry and FDA Staff – Fee PDF Download
Pharmaceutical

General Principles of Software Validation; Final Guidance for Industry and FDA Staff – Fee PDF Download

Posted on January 28, 2019 by admin

This guidance describes how certain provisions of the medical device Quality System regulation apply to software and the agency’s current approach to evaluating a software validation…

Clean Rooms and Controlled Environments – Free PDF download
Pharmaceutical

Clean Rooms and Controlled Environments – Free PDF download

Posted on January 28, 2019 by admin

Important note regarding FDA Aseptic Guidelines: –  FDA Aseptic guidelines do not allow averaging at a sampling site! –  Each discrete sample must be below the…

USP Guidances on Environmental Control including related USP, FDA, EMEA & PDA Activities –  Free PDF download
Pharmaceutical

USP Guidances on Environmental Control including related USP, FDA, EMEA & PDA Activities – Free PDF download

Posted on January 28, 2019 by admin

A New Reality? “It is not possible to maintain a manufacturing environment that is sterile. In any environment where human operators are present microbial contamination is inevitable.…

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