European Pharmaceutical Review

APRIL 18, 2024

It is important to understand the quality assurance/quality control (QA/QC) specifications for analytical methods that will be used. Stakeholders’ awareness and engagement about environmental impacts, resource use and pollution could change the requirements and the strategies of environmental monitoring.

Pharmaceutical Companies 82

Pharmaceutical Companies Pharmaceutical Companies 82

Board Vitals - Pharmacist

DECEMBER 5, 2023

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Documentation 52

Documentation Immunization 52

Impact Pharmaceutical Services

NOVEMBER 1, 2023

Challenge The client lacked the internal resources to review and validate its strategy and approach to its first commercial program. They needed CMC support for their first drug which has “breakthrough” designation.

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ISPE

JULY 20, 2023

Instead, the hackathon encourages participants to use the resources provided to address the challenge. The hackers then had 24 hours to crack the three-part case of: Reducing Cost of Goods Sold (COGS) of ATMPs, Reducing QC test timelines of ATMPs, and Identifying the most suitable location in Europe for an ATMP manufacturing site.

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ISPE

NOVEMBER 10, 2022

We are missing data in the required formats to apply advanced analytics on significant parameters and from QC data that would aid us to continuously optimize the product and process over time. The hope is that this mode of QA using real-time measurement and control can replace QbT.

Documentation 98

Documentation Compounding Hospitals Immunization 98

ISPE

MAY 9, 2023

There are so many other biotech and pharma companies in this region that all the necessary departmental needs are here, including manufacturing technicians, facility mechanics, process and automation engineers, supply chain, validation specialists, and those experts in QA and QC.” 2 Research Triangle Park. Accessed 25 January 2023.

Vaccines 94

Vaccines Pharmaceutical Companies Pharmaceutical Companies Medical Schools 94

ISPE

SEPTEMBER 12, 2022

Let me also add that we have been putting additional resources into our India office. Others were detected by the crucial final QC sterility test. It is presumed that sometime in June we will be getting closer to a normal cadence of inspections. Some of these were detected by media fills.

FDA 52

FDA Documentation Communication 52