Applying Quality by Design Concepts to Pharmacy Compounding.

Compounding of medications is an important part of the practice of the pharmacy profession. Because compounded medications do not have U.S.

Pharmaceutical compounding or pharmaceutical manufacturing? A regulatory perspective.

At one time, nearly all prescriptions were compounded preparations. There is an ongoing demand for compounded prescription medications because manufacturers cannot fulfill the needs of all individual patients. Compounding pharmacies are a long standing yet less frequently discussed element in the complex matrix of prescription drug manufacturing, distribution, and patient use.

Best practices for the development, scale-up, and post-approval change control of IR and MR dosage forms in the current quality-by-design paradigm.

In this whitepaper, the Manufacturing Technical Committee of the Product Quality Research Institute provides information on the common, best practices in use today in the development of high-quality chemistry, manufacturing and controls documentation. Important topics reviewed include International Conference on Harmonization, in vitro-in vivo correlation considerations, quality-by-design approaches, process analytical technologies and current scale-up, and process control and validation practices. It is the hope and intent that this whitepaper will engender expanded dialog on this important subject by the pharmaceutical industry and its regulatory bodies.

Sampling results of the improved SKC diesel particulate matter cassette.

Diesel particulate matter (DPM) samples from underground metal/nonmetal mines are collected on quartz fiber filters and measured for carbon content using National Institute for Occupational Safety and Health Method 5040. If size-selective samplers are not used to collect DPM in the presence of carbonaceous ore dust, both the ore dust and DPM will collect on the quartz filters, causing the carbon attributed to DPM to be artificially high. Because the DPM particle size is much smaller than that of mechanically generated mine dust aerosols, it can be separated from the larger mine dust aerosol by a single-stage impactor.

Differential pressure response of 25-mm-diameter glass fiber filters challenged with coal and limestone dust mixtures.

This article summarizes results of research conducted by the National Institute for Occupational Safety and Health (NIOSH) at its Pittsburgh Research Laboratory. The objective of this work was to determine the correlation between the mass (M) of respirable coal and limestone dusts collected on 25-mm-diameter glass fiber filters mounted in cassettes and the increase in differential pressure (deltaP) that develops across the filters when drawing at constant air flow. Test aerosols were generated inside a laboratory dust chamber using various coal dusts, limestone dust, and mixes of the two.