GMP Trends and Analyses!

06.04.2015

A NEW CHANCE FOR AN MRA?

The continuously changing production landscape, the large number of production sites outside the US, medicinal product shortages are all among the factors that let the US FDA change their view: in future the authority will rely more on a quality culture much rather than merely inspect compliance with regulations. For that purpose the authority will be re-structured. Please read more here

MICROBIOLOGY CONFERENCE ANS BIOBURDEN WORKSHOP PROVIDE FOOD FOR THOUHT

As in the years before the annual conference provided microbiologists with applicable knowledge and Know-how as well as food for thought for their daily practice. The preceding workshop concentrated on the regulatory background and practical examples and strategies for the control of bioburden. Please read more here

06.10.2014

PARTICULATE MATTER GUIDANCE: COMMENTARY REGARDING THE NEW USP CHAPTERS <787> AND <1787>

The USP Dosage Forms Expert Committee has developed both new and revised general chapters that provide guidance on particulate matter content of injectable drug products. Please read more here

06.10.2014

ANALYTICA l QUALITY CONTROL: ECA WORKING GROUP DEVELOPS SOP ON OOE AND OOT

Until a couple of years ago there was a number of issues that had not been addressed adequately. Reason enough for the ECA Foundation to establish a working group to cover these issues. Now the group already works on its second SOP. Please read more here

06.10.2014

PHARMA WATER: SAVING POTENTIAL FOR ENERGY COSTS

Water is an important raw material in pharmaceutical operations. In a decision for or against a water system issues like operating costs, energy efficiency, environmental protection and sustainability increasingly gain in importance. Please read more here

06.10.2014

THE MOST FREQUENT GMP VIOLATIONS IN THE MIRROR OF THE FDA WARNING LETTERS

The systematic analysis of the Warning Letters of the FDA to medicinal product manufacturers, manufacturers of blood and blood products as well as to API manufacturers has already been existing for 12 years. At first glance, the analysis of last fiscal year's Warning Letters doesn't hold any surprises. Please read more here

06.10.2014

ECA/PQG GUIDELINE FOR THE INTERPRETATION OF GOOD DISTRIBUTION PRAC TICES (GDP)

In March 2013 the EU Commission published the GDP Guideline - and issued changes end of the same year. Still, despite the changes there are many details that need explanation. For that reason two industry interest groups got together to jointly work on a guideline for the implementation of the EU GDP requirements in the day-to-day business. Please read more here

07.04.2014

FDA/GMP TRENDS IN THE MANUFACT URE OF ASEPTIC AND SOLID DOSAGE FORMS

More than 70 lectures - mostly case studies from the pharmaceutical industry - as well as live demos and panel discussions were on the agenda of the well attended Pharma Congress end of March in Düsseldorf/Neuss. On the two Congress days everything revolved around current challenges, solution approaches and networking. Please read more here

07.04.2014

TABLETING PROBLEMS - CAUSES AND REMEDIES

How many pressing stations a tablet press has is frequently one of the first questions when evaluating new presses. In reality, the number of pressing stations used to manufacture a number of tablets rather has a subordinate meaning, though. Please read more here

07.04.2014

THE NEW CHANGES TO USP CHAPTERS FOR PARTICULATE MATTER GUIDANCE

The cGMPs merely state to exclude foreign matter and to minimize foreign particle content. The USP can provide further guidance with regard to definitions, methods, and limits for visible and subvisible particles, though. And this does not only apply to sterile injectable products, but also to biotherapeutic and ophthalmic products. Please read more here