Remove Article Remove Data Entry Remove Labelling
article thumbnail

Preparing for an Inspection or Accreditation Survey – Part 2

National Association of Boards of Pharmacy

Then, walk through each step of the practice of pharmacy such as data entry; drug utilization review; compounding; final association between the drug, the prescription, and the label (eg, the dispensing act); and patient counseling.

article thumbnail

Advancement through adversity: how Covid-driven innovations are becoming best practices for pharmacovigilance

Pharmaceutical Technology

AEs can be caused by using medicinal products within or outside the terms of their marketing authorisations (such as off-label therapeutic use, overdose, misuse, abuse or medication errors), as well as from occupational exposure. These were then routed to the appropriate translation workflow to be given a certified translation.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Deviation investigation guidelines in the pharmaceutical industry

GMPSOP

Packaging/labeling/Misbranding: 41 warnings vi. Similarly, the packaging, labeling, and misbranding-related warning letters were the top reasons in 2019. This article will explore more elements of unplanned deviations than planned deviations. incorrect data entry). CGMP Deviation: 39 warnings ii.

article thumbnail

What are the elements of quality control process in pharmaceuticals

GMPSOP

– Record or capture all generated raw data directly, promptly, and legibly. – Use traceable data sheets or sequentially numbered notebooks. – Date and sign or initial data entries on the day of entry. – Archive records so that they are protected, secured, and easily retrievable.

article thumbnail

How to perform operational qualification – step by step

GMPSOP

In this article, we will explore what operational qualification entails, its importance, and FDA requirements. The data entry and retrieval process, user access and security, electronic signature, audit trail, system integration, performance, printing, etc. 90% to 110% of the label claim). are functioning as expected.