Regulatory Oversight

On Feb. 4, 2011, the European Medicines Agency released new document on drug products that are manufactured using stem cells.

The European Medicines Agency has released a new Annex 11-Computerized Systems to its GMP Guide Chapter 4 on Documentation to account for the increased use of and complexity of computerized systems in the drug-manufacturing community.

As biologic-drug patents move toward expiration in the US, Indian firms with experience in the follow-on biologics arena are eager to partner with global manufacturers and secure their place in the growing biosimilars market.

Taking care to note, file and re-check information can save one from future mishaps.

The author describes why statistical significance would impose an unreasonable burden on manufacturers.

FDA published its long-awaited guidance titled Process Validation: General Principles and Practices this week.

FDA issued a draft guidance for industry on Jan. 18, 2011, about the size of beads within drug products labeled for sprinkle.

The European Commission and Medicines Agency seem to be moving in advance of their ICH partners to update standards.

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The US Food and Drug Administration issued a draft guidance last week on the Qualification Process for Drug Development Tools.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