article thumbnail

PDA revises report on glass container manufacturing

European Pharmaceutical Review

Having been originally published in 2007, then revised in 2013, this latest 2023 edition addresses evolving standards and container types. Specifically, the document covers the development process of glass containers for pharmaceutical products, glass container sampling as well as definition of lots.

article thumbnail

Annex 1 Implementation Strategies

ISPE

First published in 1989, there have been a total of 5 adaptations in 1996, 2003, 2005, 2007 and 2009, but no complete revision. Annex 1 of the EC GMP Guide " Manufacture of Sterile Medicinal Products " has a long history. In 2012, there was a proposal for a complete revision which resulted in a concept paper in 2015.

Insiders

Sign Up for our Newsletter

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

Trending Sources

article thumbnail

Life in phase III: How effective data management can support NHS Trusts to hit their targets

pharmaphorum

This document, which went out at the end of July, outlines exactly what providers need to be doing. million , the highest since the referral to treatment pathways began being measured in 2007. In summary, they must: Continue to accelerate the return to normal levels for non-COVID health services.

article thumbnail

The Ripple Effect: How Pharmaceutical Advertisements Impact the Industry and Beyond

Pharma Marketing Network

Narrative review: the promotion of gabapentin: an analysis of internal industry documents. As such, it is important for the industry to carefully consider the effects of these advertisements and to take steps to ensure that they are promoting the right messages in the right ways. References: 1. Knopf Doubleday Publishing Group. Goozner, M.

article thumbnail

Sweeping changes in leaked EU pharma law draft reignite profit vs access conflict

Pharmaceutical Technology

But the EU draft document says that the changes will make medicines more affordable, improve unequal access to medicines across the EU, and fulfil unmet patient needs. The post Sweeping changes in leaked EU pharma law draft reignite profit vs access conflict appeared first on Pharmaceutical Technology.

article thumbnail

IT Infrastructure in the Current Life Science Company Environment

ISPE

While the expectations for what IT Infrastructure is supposed to do, namely provide a reliably stable, secure and controlled platform for business applications, have not changed at all from those in 2007 when the first edition of GAMP 5®, the nature of the infrastructure and the manner in which it is managed has undergone two principal changes.

article thumbnail

EU pharmaceutical legislation revisions: what are the implications for biopharma?

European Pharmaceutical Review

In October 2023, the European Parliament (EP) proposed revisions to the European Commission proposals with diverging views on various topics set out through two documents. Figure 2: European Commission proposed changes to regulatory data protection periods for non-orphan and orphan drugs (Source: L.E.K) What are the latest amendments?