2018 Documentation Packaging 
European Pharmaceutical Review
NOVEMBER 24, 2022
One area in which the problem can be tackled effectively is product packaging. With predictions that the global market for anticounterfeiting packaging is set to reach almost $250 billion by 2026, growth in authentication and anti-tamper devices such as holograms appear to have a healthy future.” percent to as low as 0.20
The FDA Law Blog
JULY 10, 2023
Performance Metric FY 2018 FY 2019 FY 2020 FY 2021 FY 2022 Average Number of FDA Days to MDUFA IV Decision 72.62 In this case, the FDA clock start date is determined as the date of receiving the submission by the Document Control Center (DCC). Attachment number) and document name or description as appropriate.
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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. Many organizations already have documented process maps.
Omnicell
JANUARY 10, 2023
million doses were diverted in 2018, equal to the population of Arizona and California combined. Hospitals are already using Fresenius Kabi Simplist® MicroVault® prefilled syringes to help nurses spend less time preparing doses and documenting waste. And according to the 2019 Drug Diversion Digest , 47.2
The FDA Law Blog
SEPTEMBER 26, 2022
FDA published a proposed list on June 13, 2018 (83 FR 27609), which we blogged about here. much like an FDA guidance document. The list of alternative mechanisms for complying with Part 211 in this FR Notice is not different from what was proposed in the 2018 FR Notice. FDA must also review the list periodically.
PQA
JUNE 27, 2024
From 2018-2019, PQA convened a multistakeholder Specialty Pharmacy Turnaround Time Task Force to develop specifications for the measure concept, focused on establishing a standardized measure of the time between a specialty pharmacy receiving a new prescription for a specialty medication and the product being available for the patient (i.e.,
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.” There have been problems with records in the past: deceit, falsification of documents and even outright fraud.
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