Quality by Design

A summary of the latest steering committee and expert working groups' meeting.

International Federation of Pharmaceutical Manufacturers and Associations takes global action to improve public health.

Industry buy-in is increasing as pharma companies proceed with select projects and research.

Last week, Ben Venue Laboratories decided to exit the contract-manufacturing business during the next several years, thus ending more than 70 years of service in this field. To ensure the supply of medically necessary products, the company will work with its customers to develop and execute long-term transition plans.

We try to use previous experience to develop the optimal granulation process for each new ingredient, but we sometimes get it wrong. Many times, we?ve taken materials from the granulator only to find that they exhibit poor flow and insufficient density. How can we easily determine the end point of a given granulation process?

Achieving a consistent level of quality control could greatly reduce waste and save money for the pharmaceutical industry. But why has talk about Six Sigma died down at a time when it could be of great benefit?

EMA has concluded in a recent report that a pilot program investigating the mutual benefits of joint international inspections of API manufacturing facilities has been a success. FDA has also reached a similar conclusion based on the findings.

The International Society for Pharmaceutical Engineering published a guidance document that defines current best practices in pharmaceutical manufacturing applications for handling gases that come into direct contact with the biopharmaceutical and pharmaceutical process steams.

Quality management requires more effort in a complex supply chain.

Pfizer's Experience with QbD. This article is part of a special issue on Outsourcing.

Supplier differentiation is increasingly important in the highly competitive arena of pharmaceutical outsourcing.

An Industry Roundtable Moderated by Patricia Van Arnum and Rich Whitworh. Contract service and technology providers share their perspectives on the influence of quality by design in the expectations between sponsor companies and outsourcing providers.

We?re attempting to validate a clean-in-place process using total organic carbon (TOC) as the analytical method. Our swab-sample recovery tests are giving us inconsistent results. Recovery values range from 95% to 205%, and there seems to be no correlation with the amount of drug product deposited on the coupon. What could be the problem?

FDA banned the importation of products manufactured at the Mexican unit of Dr. Reddy's Laboratories. The import ban is a result of the company's failure to correct the violations listed in a recent Warning Letter to the agency's satisfaction.

A PQRI expert working group provides case study examples of risk-management applications.

The traditional method of conveying information in the brief summary of a printed prescription-drug advertisement is neither the most comprehensible nor the most preferred by consumers, according to an FDA study.

The US Supreme Court ruled in favor of Roche in a patent-dispute case the pharmaceutical company had with Stanford University in a 7-2 vote.

An independent report released by the European Medicines Agency highlighted a number of recommendations to aid the agency in its communication of the benefits and risks of medicines.

Industry associations will soon provide new recommendations about extractables and leachables.

FDA has released a list of its strategic priorities for the next five years to address new global challenges.

The need for greater process understanding raises the bar for suppliers.

On Mar. 23, 2011, sanofi-aventis offered $7 billion in notes to fund its acquisition of Genzyme. The notes are offered in six tranches scheduled to come due between 2012 and 2021, and the interest rates range from 0.05% to 4%.

The Bulk Pharmaceutical Task Force (BPTF) of the Society for Chemical Manufacturers and Affiliates (SOCMA) and the European Fine Chemicals Group (EFCG) of the European Chemical Industry Council (CEFIC) are calling on FDA to mandate inspections of foreign active pharmaceutical ingredient (API) manufacturing sites with the cost borne by those sites being inspected. Both organizations have indicated a willingness to pay fees for these inspections when performed on their member-owned facilities that are located outside the United States.

A number of European public health and transparency campaigners believe that conflict of interest rules may have been breached with the EMA's decision to allow its former Executive Director, Thomas Lönngren, to take up an advisory role within the private pharmaceutical sector.

The author provides an overview of QbD implmentation for biopharmaceuticals.

Pharmaceutical Technology's annual survey on equipment and machinery reveals the spending levels and type of spending made in 2010 and planned for 2011.

The EU Commission is on the lookout for "potentially problematic patent settlements" and has asked several pharma companies to submit copies of their patent settlement agreements made between originator and generic companies.

Iain Moore explains what progress has been made so far regarding EU plans to regulate excipients.

Excipients should be regulated to manage risk. Although, excipients are an integral part of a finished pharmaceutical product, the issue of regulation is complex.

Holding product and supply-chain security to the highest standards is crucial for the future.