Preparation of intravenous cholesterol tracer using current good manufacturing practices

A Practical Approach to Validation of HPLC Methods Under Current Good Manufacturing Practices

Analytical methods validation is an important regulatory requirement in pharmaceutical analysis. High-Performance Liquid Chromatography (HPLC) is commonly used as an analytical technique in developing and validating assay methods for drug products and drug substances. Method validation provides documented evidence, and a high degree of assurance, that an analytical method employed for a specifi...

Current good manufacturing practice for positron emission tomography drugs.

The Food and Drug Administration (FDA) is issuing regulations on current good manufacturing practice (CGMP) for positron emission tomography (PET) drugs. The regulations are intended to ensure that PET drugs meet the requirements of the Federal Food, Drug, and Cosmetic Act (the act) regarding safety, identity, strength, quality, and purity. In this final rule, we are establishing CGMP regulatio...

Impact of current good manufacturing practices and emission regulations and guidances on the discharge of pharmaceutical chemicals into the environment from manufacturing, use, and disposal.

The current Good Manufacturing Practice (cGMP) and effluent emission (use and disposal) regulations of the U.S. Food and Drug Administration (FDA) and manufacturing effluent discharge and emission regulations of the U.S. Environmental Protection Agency (U.S. EPA) require contained manufacture, use, and disposal of pharmaceuticals with the goal of minimizing the release of pharmaceutical chemica...

Good Architecture = Good (ADL + Practices)

In order to ensure the quality of their software development, companies incorporate best practices from recognized repositories or from their own experiences. These best practices are often described in software quality manuals which does not guarantee their implementation. In this paper, we propose a framework for the implementation of best practices concerning the design of the software archi...

Good Practices in Development Communication Good Practices in Development Communication