Process and Scaling

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.

Arthur R. Mlodozeniec, PhD, a member of Pharmaceutical Technology's advisory board and past president of AAPS, died on Sept. 4.

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.

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

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.

Thanks to you, we have this month's column. Keep those cards, letters, and e-mails coming.

This article summarizes changes to the Akers–Agalloco aseptic processing risk analysis model (first presented in Pharmaceutical Technology's November 2005 issue) as well as some of the underlying thinking behind the revision. The simplified model makes the method easier to use because of its greater flexibility of environmental control practice. It maintains the emphasis on human activity as the primary consideration in risk management for aseptic processing.

My audit host clearly knew and lied about the planned changes.

I always suspected that our purchasing manager had agreed to this just to save money . . .

Predictable outcomes lead to greater manufacturing efficiency and speed time to value.

On April 28, the US Food and Drug Administration's Center for Drug Evaluation and Research (Rockville, MD) issued a Warning Letter to Pliva Hrvatska d.o.o., a subsidiary of Pliva d.d. (Zagreb, Croatia).

Animal testing and accounting can both be hazardous.

The author explores the importance of the proposals to revise Annex 1 of the EU GMPs in the context of the desire for science-based, internationally respected GMPs. Commentary also is provided about the relationship between this annex and CEN–ISO cleanroom standards.

The need to curb drug counterfeiting is spurring development of track-and-trace and product authentication technologies.

Performing D-value and population verification is critical in the acceptance criteria for allowing a new lot of biological indicators into a facility before acceptance and use of the lot in validation work or routine monitoring of sterilization cycles.

Vitamin D and a sunny window shed som light on product stability.

All sectors of manufacturing are under continual pressure to bring new products to market quicker, stealing a march on the competition and maintaining their revenue stream.

Adding a cleaning step to the field-testing protocol, and combining it with the data generated to register sanitizing and disinfectant agents under FIFRA and the CEN TC 216 work program, produces a sanitation-and-disinfection validation methodology that is cost-effective, simple, and time-saving.

Madness in March: lost ingredients, missed lot numbers, and a million-dollar photo.

Analytical tools and methods that require less water and detergent are gaining interest for faster, more efficient cleaning.

Because of the growing popularity of single-use materials, the identification, characterization, and qualification of new materials used for disposable processes have become increasingly important for both regulatory and production purposes. This article describes one approach to identifying and validating the materials used in a disposable filling process.

Warning Letter: Southern Meds

"It was the late 1970s," reports our GMP-Agent-in-Place, "and we used a primitive desktop computer with built-in teletype for our quality control work.

Extractable and leachable issues should be resolved early in the drug manufacturing process. Open communication is imperative for a successful study.

A particular dermatological product was packaged in a metal tube, which is filled from the bottom.

FDA issues a warning letter to Nephron Pharmaceuticals.

To qualify and validate a pharmaceutical manufacturing facility, one must carefully review the facility design for compliance with good manufacturing practices and manage project scope definition, labor and cost estimating, and master-plan development.These activities, properly implemented, help deliver a validated facility on schedule, at the estimated cost, and with expected quality.

A new oral dosage product was designed as "encapsulated tablets." In production, the drug product was pressed into tablets, which were then fed into a revolving capsule-filling table.

In applying a visually clean standard, any residue related to the cleaning process that is visible on the surface should constitute a failure.