2015 Documentation Packaging 
European Pharmaceutical Review
AUGUST 23, 2022
Of the cGMP letters, three major types of violations – deficiencies in process validation, documentation practices (data integrity) and quality control – accounted for 26 percent, 21 percent and 15 percent of warning letters respectively. Overall, validation, documentation and quality control were the major cGMP violations.
European Pharmaceutical Review
APRIL 8, 2025
Given that multiple work packages may often start or end together, or else take longer than others ( Figure 1 ), the introduction of new PAT requires assessment and planning by multiple departments. Any documentation, such as validation reports then helps with compliance and later regulatory submissions and requests.
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The FDA Law Blog
FEBRUARY 21, 2024
This amendment marks the first significant revision of Part 820 since 1996, which established the Quality System (QS) regulation and “included requirements related to the methods used in, and the facilities and controls used for, designing, manufacturing, packaging, labeling, storing, installing, and servicing of devices intended for human use.”
The Checkup by Singlecare
FEBRUARY 28, 2024
In 2015, Pennsylvania became one of 41 states to adopt the Affordable Care Act (ACA) Medicaid expansion. Eligibility for Pennsylvania Medicaid Since adopting the ACA Medicaid expansion in 2015, Pennsylvania has implemented targeted enrollment strategies to help eligible Pennsylvanians gain coverage. million Pennsylvania residents.
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. April 2015. to Industry 4.0 2 3 a b Hankel, M.,
DiversifyRx
JULY 11, 2024
Most of the existing requirements have been in place since 2015 and require Pharmacies to have SOPs, Training, and data storage (or agreements with their ATPs in place) to maintain the required transaction data. The four requirements below are handled in various ways. Identifiers All products received must contain a product identifier.
The FDA Law Blog
OCTOBER 5, 2022
In 2015, FDA issued a Warning Letter to Kind LLC because, among other things, the company labeled products as healthy whereas these products provided more saturated fat per serving than permitted by the regulatory definition. The term healthy, as an implied nutrient claim, was first defined by FDA in 1994.
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