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Employee Spotlight: Paula Styer Pharmacy Technician

indispensable health

I have been a pharmacy technician since 2008. It has been since 2008 so it’s been good for me. It morphed into communications, but I still have a love of reading and a love of words. An Interview With Paula Styer, Licensed Pharmacy Technician (LPhT). What Is Your Name and Job Title? When Did You Become Interested in Pharmacy?

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Methodology to Define a Pharma 4.0™ Roadmap

ISPE

Published June 2008. defines a service-oriented architecture (SOA) where application components provide services to the other components through a communication protocol over a network. The goal is to break down complex processes into easy-to-grasp packages, including data privacy and information technology (IT) security.

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Contamination Trends & Proposed Solutions

ISPE

The cases covered the same types of contaminants and impurities noted in Table 1: microbial contaminants, process-related im-purities, metal contaminants, packaging-related contaminants, drug cross-contamination, and an “unknown” category encompassing other contaminants associated with the manufacturing process, including those from cell culturing.

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A New Regulatory Approach to Drive Sustainable Medicines

ISPE

As such there’s a growing question of how the industry will improve the sustainability profile of its existing medicines and ensure that sustainability is designed into new medicines, such as products, with a reduced environmental risk, greener manufacturing technologies, and recyclable delivery systems and packaging. 9 December 2021.

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A Proposal for a Comprehensive Quality Overall Summary

ISPE

Published June 2008. Challenges with the Current Module 2 Structure The US FDA published a white paper in 2018 calling for a revision to Module 2 because, “there can be a disconnect between applicants and regulators regarding the communication of quality data and its impact on the assessment.

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A Proposal for a Comprehensive Quality Overall Summary

ISPE

Published June 2008. Challenges with the Current Module 2 Structure The US FDA published a white paper in 2018 calling for a revision to Module 2 because, “there can be a disconnect between applicants and regulators regarding the communication of quality data and its impact on the assessment.

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CMC Requirements for New Drug Registration in Latin America

ISPE

In addition to the COR, some Latin American markets require approval in the COO, which is defined as the country where the drug is manufactured, packaged, or exported from. Sometimes, COAs for the drug substance, the excipients used in the formulation, and the primary and nonfunctional secondary packaging material are requested.