The People's Pharmacy
MAY 8, 2023
“The FDA said Global Pharma failed to use adequate, tamper-evident packaging and distributed the drugs without proper preservatives.” In 2007 and 2008, hundreds had allergic reactions, some fatal, to a commonly used blood thinner, prompting an FDA investigation.
European Pharmaceutical Review
FEBRUARY 2, 2023
The last paracetamol plant in Europe, closed in France in 2008 as it was no longer economically sustainable, marking the exit of paracetamol manufacturing from Europe” The closure of API manufacturing plants in Europe started in earnest 15 years ago.
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ISPE
MAY 11, 2023
The key to data integrity compliance is a well-functioning data governance system 1 , 2 in which the data flow path for all business processes and equipment—such as in manufacturing, laboratory, and clinical studies—is fully understood and documented by a detailed process data flow map. Published June 2008. to Industry 4.0
ISPE
MAY 9, 2023
Improvements have been observed by various regulatory agencies in Latin America for the acceptance and implementation of international standards—for instance, the ICH Common Technical Document (CTD) format. Additional required information beyond ICH guidelines, or non-value-added documents (e.g., 6, and 2.3.S.7 7 are required.
ISPE
SEPTEMBER 11, 2023
The setpoint for “proper” air velocity in cleanroom systems is documented in standards and regulations as 0.45 The isolator was built in 2008. x, a free and open-source computational fluid dynamics (CFD) software package. This was followed in September 2022 by the publication of the PIC/S’s identical Annex 1. m/s up to 0.54
The Thyroid Pharmacist
JULY 29, 2022
Feel free to use my own health timeline as a guideline to document your health journey. Most filter manufacturers have pictures on their filter packaging that indicate what they will and will not filter, along with the MERV rating. 2008 Nov;19(6):S207. Invest in a High-Quality Portable Air Filter. Environ Health Perspect.
ISPE
MARCH 29, 2023
Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” Published June 2008. If elements such as these are adopted during the revision of ICH M4Q, this could influence global regulatory agencies to eliminate the requirement for custom Module 2 commitment documents. The authors propose using Module 2.3
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