European Pharmaceutical Review

NOVEMBER 15, 2022

Validation projects have often been documentation-focused exercises, more befitting a grammar exercise than artifacts supportive of regulated activity. The GAMP 5 Second Edition guide emphasises that focus should be on value-adding activities rather than documentation for documentation’s sake.”

Documentation 98

Documentation FDA Pharmaceutical Companies Pharmaceutical Companies 98

Hospital Pharmacy Europe

AUGUST 7, 2024

3–5 Medication errors are often documented in national or local electronic incident reporting systems. medication room, hospital pharmacy, emergency medication cart) was described, this was also documented in Microsoft Excel. Am J Health Syst Pharm 2002 Mar 1;59(5):436–46. Br J Clin Pharmacol 2009;67(6):656–61. 5 Flynn EA et al.

Hospitals 98

Hospitals Documentation Medical Records Dosage 98

pharmaphorum

SEPTEMBER 13, 2022

The first well-documented case of multiple myeloma was reported in 1844 by renowned British surgeon Samuel Solly. 2002 – Emergence of CAR-T therapy. At the time, his hypothesis appeared to fall on deaf ears, and it would take a further three decades before Hodgkin’s discovery was recognised.

Chemotherapy 98

Chemotherapy Immunization FDA Documentation 98

European Pharmaceutical Review

JULY 20, 2023

SoHO entities must implement a traceability system to unmistakably link each SoHO donor to their SoHO donation and to all documents, samples, SoHO preparations and SoHO entities that are associated with that SoHO from the point of collection to human application and outcome monitoring. Cited 2023Mar].

Labelling 75

Labelling Documentation Hospitals 75

ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” If elements such as these are adopted during the revision of ICH M4Q, this could influence global regulatory agencies to eliminate the requirement for custom Module 2 commitment documents. The authors propose using Module 2.3 Published 15 November 2021.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” If elements such as these are adopted during the revision of ICH M4Q, this could influence global regulatory agencies to eliminate the requirement for custom Module 2 commitment documents. The authors propose using Module 2.3 Published 15 November 2021.

Documentation 52

Documentation Dosage Packaging Communication 52

The Checkup by Singlecare

JANUARY 23, 2024

Diltiazem has documented interactions with many types of medications. It has multiple approved uses related to the cardiac system including hypertension, angina, myocardial infarction (heart attack), and arrhythmias (irregular heart rhythm). There are many off-label uses of diltiazem as well.

Labelling 52

Labelling Documentation 52