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 82

Documentation FDA Pharmaceutical Companies Pharmaceutical Companies 82

The People's Pharmacy

MAY 8, 2023

In 2007 and 2008, hundreds had allergic reactions, some fatal, to a commonly used blood thinner, prompting an FDA investigation. There have been problems with records in the past: deceit, falsification of documents and even outright fraud. Since the start of 2013, pharmaceutical companies based in the U.S.

FDA 72

FDA Pharmaceutical Companies Pharmaceutical Companies Medical Schools 72

European Pharmaceutical Review

FEBRUARY 2, 2023

This left pharmaceutical companies in Europe with no European API supply source, and only a few suppliers in Asia. The last paracetamol plant in Europe, closed in France in 2008 as it was no longer economically sustainable, marking the exit of paracetamol manufacturing from Europe.

Generic Medicine 97

Generic Medicine Packaging Documentation Pharmaceutical Companies 97

European Pharmaceutical Review

FEBRUARY 1, 2024

Even though patients are on existing [statins] that are well-documented and most likely safe and effective, there are many patients who still have cardiovascular disease, the leading cause of death” We are recognising now is that there is great data on how to reduce risk by applying lipid lowering therapy like statins.

Documentation 73

Documentation Pharmaceutical Companies Pharmaceutical Companies 73

ISPE

JULY 6, 2023

For years, depository institutions such as commercial banks, operating in a highly regulated environment like the pharmaceutical industry, have been held to a high standard in managing risk at an enterprise level. One of the most important components of SRM is the company’s risk appetite statement.

Insurance 52

Insurance Documentation Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

MAY 9, 2023

In an era when the world is accelerating the development of drugs and targeted medicines using innovative technologies, pharmaceutical companies still face registration hurdles for well-characterized molecules because of redundant or additional local regulatory requirements.

Documentation 52

Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

MARCH 7, 2023

A pharmaceutical quality system (PQS) is a management system used to direct and control a pharmaceutical company with regard to quality. Guideline on the Requirements to the Chemical and Pharmaceutical Quality Documentation Concerning Investigational Medicinal Products in Clinical Trials.” Published June 2008.

Packaging 52

Packaging Pharmaceutical Companies Pharmaceutical Companies Hospitals 52