Regulatory Oversight

Sometimes doing what you think is right ends up being completely and utterly wrong.

The author explains the idea of equivalence and describes how it can facilitate equipment validation.

With the increasing need for businesses to reduce costs and demonstrate value, there is a requirement to look at all aspects of bio/pharma drug development and manufacturing to achieve efficiency improvements.

A case study describes how a software control system can manage training needs across an international company and improve GMP compliance.

IP rights and levels of innovation have opened a bit of controversy regarding decisions being made by Indian courts and legislators.

Remaining calm, cool, and collected during mergers and inspections is a feat in itself.

The US Food and Drug Administration issued a draft guidance last week on the Qualification Process for Drug Development Tools.

Public-private R&D partnerships are on the rise across Europe, but national goals and academia-industry competition could prevent their success at the European level.

From disagreement to denial, being cordial about quality control can be challenging.

A look at why Brazil revised its GMP standards and how the changes will affect the local pharmaceutical industry.

From weekend deliveries to nonsterile gloves, a single exception can make a product fall flat.

India has evolved from a low-cost region to an area with extensive technical capability and high quality standards.

The US Food and Drug Administration and European Medicines Agency (EMA) are looking for drug manufacturing companies to participate in their joint good manufacturing practice (GMP) inspection pilot program.

Fallout escalates from McNeil recall and Genzyme shortages as regulators review oversight.

Cases of overlooking proper packaging, reconstitution, directions, and dissolution.

Manufacturers and regulators on both sides of the ocean move to ensure the safety of heparin and other globally distributed drug products.

The recent amendment to Annex 1 has seen controversial changes relating to the capping of vials.

New isolator and disposable technologies are set to assume a greater role in pharma manufacturing, according to a recent conference in Germany.

Changes to Part 2 of the EU GMP guide will come into force by 31 July 2010 in order to bring it in line with the ICH Q9 guideline on Quality Risk Management. As a result, it will no longer be identical to the ICH Q7 guideline on APIs - a harmonised guideline for the US, Europe and Japan.

As generic divisions become the most-wanted acquisitions of Big Pharma, India's domestic industry may be thinning out.

Reports of overlooked controls, dropped pallets, and misplaced documents leave a chill in the air.

The US Food and Drug Administration issued on June 25 a draft guidance for industry, "CMC Postapproval Manufacturing Changes Reportable in Annual Reports," to provide recommendations to drug applicants about the types of changes that may be included in annual reports.

Europe needs a more standardised and consistent approach for supplying excipient information to the regulators.

Europe moves to place excipient GMP and GDP standards on the same level as active pharmaceutical ingredients.

Too much or too little control can actually lead to the same result.

The authors recommend a strategy for classifying similar nonstainless-steel surfaces into three groups based upon the analytical recovery that was observed in this study.

An effective quality management system will identify the root cause of non-conformances and put measures in place to ensure that they do not recur, but is the pharmaceutical industry choosing the right methods to make sure this happens?

The growth of Brazil's generic-drug market is on a fast track, but what are the projections for the sector's future?

A book helps statistics novices prepare to comply with the US Food and Drug Administration's draft guidance on process validation.

When vessels, seals, and cooling units go haywire, operators must get in the mix.