Process and Scaling

What the industry needs most is not reduced oversight. What we need is, competent, constructive, informed, consistent, fair, and predictable inspection.

To meet the requirements of the USP ^755& Minimum Fill and ^698& Deliverable Volume tests, target fill levels greater than 100% must be established.This article proposes a criterion for establishing an appropriate target fill level such that a sample will have a 95% probability of passing these USP tests at 95% confidence.

The authors argue that chlorine dioxide (CD) is a safe and effective decontaminating agent that can be used for challenging applications.The effectiveness of CD gas for sterilizing complex isolator systems is studied.

Managers of FDA-regulated firms must be proactive in how they manage their company's compliance with good manufacturing practices regulations.

A comparative study of three air samplers used for bioaerosol collection was performed to evaluate the average recovery of colony-forming units and to assess the precision of each device.

X-ray microtomography has great potential for improving the understanding of the structural features of solid dosage forms and the changes in those features during manufacturing, handling, and storage. This article describes the basic principles of the technique and provides examples of its potential applications.

The validation of alternative microbiological testing is an opportunity for a manufacturer to decrease the amount of time required for laboratory results. To properly validate these alternatives, a practitioner must first identify what is being studied. The regulatory effect on established product and process specifications and levels must be completely evaluated, as changing the method of analysis may well change the apparent number in the sample.

To meet the requirements of the USP ?755? Minimum Fill and ?698? Deliverable Volume tests, target fill levels greater than 100% must be established. This article proposes a criterion for establishing an appropriate target fill level such that a sample will have a 95% probability of passing these USP tests at 95% confidence.

Warning Letters: Alternative Health and Patient First

FDA Finalizes Guidances on Minimizing Drug Risk and Submitting Pharmacogenomic Data

FDA New Drug Review Times Continue to Drop in 2004

Warning Letter: Germiphene

Warning Letter: Germiphene

USP to Publish Spanish Translation of USP-NF; Council of Experts Named

Warning Letters: DanChem Technologies & Medsep

US Marshals Seize Supplies of GSK Paxil CR, Avandamet

UK MHRA Okays Chiron Flu Vaccine Plant; FDA Approval Still to Come

FDA Approves Treatment for Smallpox Vaccination Side Effects

IPEC-Americas has just completed a major update to its significant change guideline to address current issues in the manufacture of excipient ingredients and to assist manufacturers in developing an impurity profile.

In this time of liability reform, pharma deserves the chance to align its economic interests with its ethical obligations to the patient.

As newer and more elaborate hardware and software systems are installed in automated manufacturing environments, companies are further incorporating good practices into their validation process.

The authors evaluate the implications of product photosensitivity and how it influences various aspects of product development. They discuss a product photosensitivity classification system and present a photosensitive pharmaceutical product case study.

The author reviews dimensional analysis as a straight-forward approach to scale up.

The author describes strategies for analytical method development that are helpful in achieving quality by design and efficiency.

The author points out some major obstacles to effective scale-up and describes methods available to pharmaceutical scientists for addressing scalability issues.

In the manufacture of many pharmaceutical products, dry-particle blending is a critical step that directly affects content uniformity.

CBER Draft Guidance for Spore-Formers and Plasmid Vaccines

FDA Creates New Drug Safety Board

Lilly Implements Bar Coding on Individual Insulin Vials

Drug Safety Top Issue for New FDA Commissioner Crawford