Manufacturing

On Dec. 6, 2011, FDA announced that a public meeting will be held on Dec. 16, 2011 to discuss recommendations for a user fee program for biosimilar biological products for fiscal years 2013–2017.

Cultivating a productive investment environment will require partnerships with a range of stakeholders.

Expansion activity was limited as fine-chemical producers and CMOs of API and intermediates grapple with changing industry fundamentals.

Cleanliness is crucial, even if zapping and trapping is necessary to reduce product contamination.

The seventh in a series of eight case studies from the Product Quality Research Institute focuses on packout remedies.

As the excipient supply chain becomes more complex, industry must up the ante to comply with new standards and regulations.

Added responsibilities and outside concerns prompt overhaul of agency's structure.

New product reviews for December 2011, focusing on manufacturing.

Contract organizations must have highly organized teams and plans to accommodate today's audits.

Drug shortages, supply-chain security, generic-drug incursion, and flexible manufacturing models are some of the issues shaping the bio/pharma industry.

Political leaders need to consider the impact of the biopharmaceutical industry on the economy.

Packaging is indeed headed to be a lead sector in the Asian pharmaceutical environment, but certain challenges must first be overcome.

A Q&A with Deborah Tanner, executive vice-president and group president of R&D laboratories at Covance, on recent industry trends.

The authors developed a metronidazole-based floating drug-delivery system to investigate the effect of rate-controlling polymers on release pattern and duration of buoyancy in matrix tablets.

Readers react to the economic turmoil of the past year and look longingly forward to 2012.

Pharma companies must balance demand for new drugs while facing reduced R&D spending.

As 2011 comes to a close, a new paradigm of product development is ever more important.

Employee training-at all levels-is crucial for moving forward with a successful risk- and quality-based manufacturing strategy.

The last in a series of eight case studies from the Product Quality Research Institute focuses on internal GMP audits.

The sixth in a series of eight case studies from the Product Quality Research Institute focuses on packaging line GMP optimization.

Training cleanroom operators can be one of the most challenging aspects to maintaining cleanroom conditions. PTE speaks to Neal Wesley, technical director at SCM Pharma, to find out the best practices for training and ensuring continued compliance.

Jerold Martin, senior vice president global technical affairs, at Pall Life Sciences, explains the importance and impact of single-use systems in sterile environments.

Millions of pounds worth of products are at risk if contamination occurs in a cleanroom environment. According to an independent consultant (Cleanroom Management Associates Inc) for our company, contamination from personnel and equipment, such as wheeled carts and tanks, is a major concern in cleanrooms and controlled environments.

Contamination is almost always related to human error and there is a clear drive to reduce human implications in aseptic operations. This can be achieved in multiple ways.

PTE quizzes Jaime Cassar, cleanroom category manager at Kimberly-Clark Professional Europe, about the importance of sterile garments for cleanroom environments.

When a pharmaceutical supply chain is compromised, there can be disastrous consequences, not only for consumers, but also for manufacturers. Without comprehensive security measures, pharmaceuticals are susceptible to counterfeit, diversion, dilution, tampering and deliberate contamination—ultimately compromising patient safety.

A modular cleanroom construction is typically a freestanding, solid and robust structure that is suitable for use within an existing cleanroom, laboratory, manufacturing area or warehouse.

On Nov. 17, 2011, a bill that would increase penalties for those convicted of trafficking in counterfeit drugs was introduced in the House of Representatives. The Counterfeit Drug Penalty Enhancement Act of 2011, cosponsored by four US Senators and two US Representatives.

The EMA released a concept paper for consultation on Nov. 8, 2011, that recommends a revision to Annex 16 of the Guide to Good Manufacturing of Medicinal Products to address more complicated global supply chains and new falsified medicines legislation.

We have changed the brand of our stoppers for a product that we freeze-dry in vials. Since the change, we have observed a significant increase in rejects for collapsed cakes. Why are the cakes collapsing? What can we do to prevent this problem?