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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FDA Law Blog: Biosimilars
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.”
PharmaTech
JUNE 23, 2025
It builds on drug calculations topics previously described (1), including guidance documents (2–5). FDA guidance documents illustrate labeling salt drugs and associated active moieties. From the Dilantin package insert: “The free acid form of phenytoin is used in DILANTIN-125 Suspension and DILANTIN Infatabs. YouTube.com , Dec.
The Thyroid Pharmacist
JULY 29, 2022
About 10 percent of those in my 2015 survey of 2,232 people with Hashimoto’s said that mold was a trigger for them… and those were only the ones who had already uncovered the issue. Feel free to use my own health timeline as a guideline to document your health journey. doi:10.1155/2015/760689. 2015 Jan 1;20:872-91.
PharmaShots
JUNE 1, 2023
These new results reinforce our differentiating data package for PDC*lung01. 2015; Zhu et al., The durability of response in all first-line stage IV (metastatic) NSCLC patients with partial response or stable disease is particularly encouraging and provides hope for this patient group where there is still a significant unmet need.
Express Pharma
MAY 14, 2025
Each proposition is grounded in a set of assertions that are supported by extant evidence from published articles or publicly available documents. A key part of the system requires drug packages be affixed with QR codes, which represent the fundamental data carrier for the entire programme.
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