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.

FDA 89

FDA Documentation Packaging Labelling 89

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.

Packaging 52

Packaging Documentation Hospitals Insurance 52

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.

FDA 52

FDA Labelling Packaging Documentation 52

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.”

FDA 59

FDA Labelling Packaging Documentation 59

The Checkup by Singlecare

FEBRUARY 16, 2024

“Antioxidant” has become a hyper-common wellness buzzword, slapped on health food packages so often that many people don’t think twice about it. 10 potential health benefits of NAC Some of NAC’s uses are time-tested and well-documented, like its efficacy in treating acetaminophen overdose. But it’s not just a long-term treatment.

Immunization 83

Immunization Dosage Packaging FDA 83

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.,

Packaging 52

Packaging Documentation Communication Data Entry 52

ISPE

SEPTEMBER 11, 2023

Regulatory Background and Cleanroom Air Velocity In 2015, the authors of the Concept Paper on Revision of Annex 1 decided to harmonize the regulatory framework globally, including established methodologies such as those from the International Organization for Standardization (ISO). Published 2 February 2015. m/s up to 0.54

Documentation 52

Documentation FDA Packaging Communication 52