Quality Systems

Rockville, MD (Sept. 28)-The US Food and Drug Administration has withdrawn three guidances for industry: ?Providing Submissions in Electronic Format?NDAs? (e-NDA), ?Providing Regulatory Submissions in Electronic Format?ANDAs? (e-ANDA), and ?Providing Regulatory Submissions in Electronic Format: Annual Reports for NDAs and ANDAs.? These documents all recommend submitting information as portable document files (PDFs) or as SAS transport files.

The specialty excipients market in the United States, Western Europe, and China is valued at nearly $800 million. The authors discuss the opportunities and challenges in these markets by examining the product mix, supply base, and preferred production methods.

A recent analysis found that 9000 marketed drugs are not in FDA's National Drug Code Directory.

GlycoFi's work could eliminate the need for mammalian cell culture and improve the performance of protein therapies.

Getting "swamped at work" takes on an entirely new meaning for these GMP Agents.

Developed in the 1950s as a means to survive and compete against the giants of the automotive sector, lean manufacturing helped Toyota evolve from a small-volume producer (with little capital) to become a high-volume manufacturer in a process-rich environment. Toyota achieved this by using developments such as total production maintenance (TPM), just-in-time (JIT), Kanban, value stream mapping and Kaizen events.1 A summary of some of the lean terminology is shown in Table 1.

It will remain to be seen whether pharmaceutical companies will commit lock, stock and barrel to being green.

Washington, DC (Sept. 26): A much-publicized Institute of Medicine report, "The Future of Drug Safety: Promoting and Protecting the Health of the Public," though devoted to the assessment and perception of risk, focuses on premarketing clinical reviews and postmarketing pharmacovigilance. It does not address or make recommendations on drug manufacturing or quality assurance.

Kevin Sharer has become chairman of the board of the Pharmaceutical Research and Manufacturers of America upon the resignation of Peter R. Dolan.

Washington, DC (Sept. 12)-The Office of New Drug Quality Assessment (ONDQA) in the Center for Drug Evaluation and Research (CDER) has approved one new drug application (NDA) under its CMC Pilot Program and has two more applications are under review. The pilot was established last year to provide an opportunity for FDA and industry to explore strategies for including Quality by Design (QbD) principles and process analytical technology approaches in regulatory submissions, explained ONDQA deputy director Chi-wan Chen at the PDA-FDA Joint Regulatory Conference here

Washington, DC (Sept. 1) - In a Federal Register announcement the US Food and Drug Administration laid out its guidance agenda for the coming months.

As the pace of product development accelerates, the approach to dissolution-method development must advance beyond a manual method and an assay. A natural progression of the method-development process must include the transfer of the manual method onto automated instrumentation.

Before formal cleaning validation programs were instituted, visual inspection was the primary means of determining equipment cleanliness. The use of visual inspection is still typically a component of a cleaning validation program and for routine inspections of cleaning effectiveness, but the use of visual inspection as a sole criterion for equipment cleanliness has not been successfully implemented as a valid approach for cleaning validation.

I recently embarked on a quest: to investigate industry's use of the words, "generic" and "biosimilar" when describing a biologic molecule. An English major at heart, I was wrapped up in a news story that was partly about science, partly about words.

FDA will strengthen its collaborative relationships with federal agencies participating in the National Nanotechnology Initiative.

Apparently, the inspector would sneak off to visit his relatives on FDA time, instead of visiting us.

Partnerships launched 63 research projects that may translate into nine or 10 new drugs by 2010.

Now is the time to get ahead of the learning curve and explore options for meeting pedigree guidelines.

Implementing an electronic system to track out-of-specification results could help ensure compliance with current good manufacturing practices, but the system must be 21 CFR Part 11 compliant and easy to install, maintain, and use.

Companies must create a risk-based framework for developing and manufacturing drugs, and acquire the scientific knowledge and technological skills to create more complex products.

A contract manufacturing organization must clearly identify the goals of a project, establish a plan, and then effectively execute accordingly.

The International Organization for Standardization (ISO, www.iso.org) has formally issued and published standard ISO 4644-8:2006, Cleanrooms and associated controlled environments-Part 8: Classification of airborne molecular contamination. The document covers the classification of airborne molecular contamination (AMC) in cleanrooms and associated controlled environments in terms of airborne concentrations of specific chemical substances (individual, group, or category) and provides a protocol to include test methods, analysis, and time-weighted factors within the specification for classification.

The US Food and Drug Administration's New Jersey District Office issued a Warning Letter to Concord Laboratories (Fairfield, NJ), citing the company for manufacturing three generic products without an ANDA, and for ten deviations from current good manufacturing practices.

The US Food and Drug Administration (Rockville, MD) has sent warning letters to RoTech Healthcare, Inc. (Orlando, FL), CCS Medical (Clearwater, FL), and Reliant Pharmacy Services (Clearwater, FL), demanding that they stop manufacturing and distributing compounded, unapproved respiratory drugs.

On Oct. 10, the US Food and Drug Administration (Rockville, MD) will hold a public meeting on products containing nanotechnology materials.

The US Food and Drug Administration has opened the FDA Electronic Submissions Gateway (ESG) to receive and process regulatory submissions to the Center For Biologics Evaluation and Research, the Center for Drug Evaluation and Research, and the Center for Devices and Radiological Health.

The US Food and Drug Administration has published a draft guidance, Q4B Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria (RAAPAC).

Schering AG (Berlin, Germany) voluntarily issued a worldwide recall of all lots of its X-ray contrast agent "Ultravist Injection" 370 mgI/mL (iopromide injection) because particulate matter and crystallization may be present in the product.

The US Food and Drug Administration announced its Prescription Drug User Fee Amendments of 2002 (PDUFA II) fees schedule for fiscal year 2007 (Oct. 1, 2006 - Sept. 30, 2007), including increases ranging from 17% to 19%.

Disappointed in progress thus far, the US Food and Drug Administration wants pharmaceutical manufacturers to make a greater effort to combat counterfeit products and recommends that they "move quickly" to implement radio-frequency identification technology.