Communication Documentation Packaging 
European Pharmaceutical Review
OCTOBER 3, 2024
Indeed, a key aspect of EU GMP Annex 1 is the requirement for pharmaceutical manufacturers to develop a comprehensive Contamination Control Strategy (CCS) that documents their approach to assuring the sterile drug product’s high quality and, therefore, enhancing patient safety. Register your details to read more The post How ready are you?
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.”
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pharmaphorum
OCTOBER 27, 2022
The overarching principle set out in Codes of Practice, and in particular the Principles for the use of digital channels in the EFPIA Code , is that the legislation and Codes of Practice apply equally to communications by companies on social media and digital channels.
The FDA Law Blog
JULY 10, 2023
FDA communicates via a Substantive Interaction to inform the submitter either that FDA will proceed with Interactive Review or that the 510(k) will be placed on hold until FDA receives a complete response to an Additional Information request. By Day 15 FDA conducts Acceptance Review. By Day 60 FDA conducts Substantive Review.
DiversifyRx
OCTOBER 20, 2022
’ You want to ensure that you document the attestation every time you dispense the at-home COVID tests for a patient. When you communicate with the employer to have people sign up for a vaccine, have them simultaneously sign up for the at-home COVID tests. Here is a basic summary of all the best practices from people there.
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. It supports the analysis of Industry 4.0 to Industry 4.0
European Pharmaceutical Review
JANUARY 25, 2024
These standardised documents provide meticulously curated and scientifically approved information. 7 Access to digital communications also remains a challenge in some Member States especially for those groups at risk of poverty and social exclusion (7.6 percent as EU average with some Member States as high as 25 percent).
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