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Cell and gene therapies (CGTs) are reshaping multiple therapeutic areas, including oncology, rare diseases, bleeding disorders, and monogenetic disorders, giving patients new, potentially curative treatment options. The first commercial cell [...]

Messenger RNA (mRNA) is an ingenious natural molecule involved in the creation of proteins, which are essential to biological processes. This same molecule is the basis of a new breed [...]

As pharmaceutical manufacturers continue to outsource more manufacturing and quality functions to contract partners, the question of who owns final product quality has become more complex. In the end, the [...]

Look to Asia for generic manufacturing. [ABSTRACT FROM AUTHOR]

For the past few years, to help pharmaceutical manufacturers improve and sustain better product quality, the US Food and Drug Administration (FDA) has been working with industry to define the [...]

The author provides a review of FDA'S guidance document, Guidance for Industry: Q11 Development and Manufacture of Drug Substances, and its relation to the International Conference on Harmonization's Q11 document [...]

On October 25, 1994, President William Jefferson Clinton signed the Dietary Supplement Health and Education Act (Public Law 103-417), also known as DSHEA. (1) This act was designed to protect [...]

Over the past few years, after some notable failures at a number of companies (1), global regulators have been paying much closer attention to how pharmaceutical manufacturers safeguard the integrity [...]

'Microbiology Topics' discusses various topics in microbiology of practical use in validation and compliance. We intend this column to be a useful resource for daily work applications. [ILLUSTRATION OMITTED] Reader [...]

This article deals about the Government Perspective on the Life Science in Taiwan. [ABSTRACT FROM AUTHOR]

As schools in the United States close for the summer break, student grades serve as a measure of how well teachers shared knowledge, how well students understood and retained that [...]

'Compliance Case Studies' discusses compliance situations useful to practitioners in compliance and validation. Each case presented deals with a specific compliance problem, elements of which are described with the intention [...]

The European Union-United states mutual recognition agreement (MRA) on GMP inspections, announced in early March 2017 (1), was a big step forward in the EU's eagerness to play a key [...]

With the publicity surrounding the recovery of mold from pharmacy compounding facilities and formulated products connected to patient fungal infections and deaths, there has been a heightened awareness and concern [...]

Q: Our company covers the entire lifecycle for our drugs, from R&D through clinical trials to commercial product. The quality management system covers good clinical practice (GCP) and current good [...]

Tablet manufacturing problems and tablet-tooling failures are generally the result of one or a combination of the following: * Difficult product/granule * Inappropriate tablet design * Incorrect tablet-press setup and [...]

Contamination in all its forms should be identified and reduced whenever and wherever possible. The best managed cleanrooms/critical environments start at the entrance to the building and implement a holistic [...]

FDA has released a list of more than 50 guidance documents planned for 2013. Planned documents include, among others, Quality Systems Approach to Pharmaceutical cGMP Regulation, Uniformity of In-Process Mixtures, [...]

Q: How closely does FDA expect API manufacturers to adhere to ICH Q7 for GMPs? A. ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, like its ICH Q1-Q11 [...]

The walls have ears 'She was a sneaky inspector is all I have to say,' grouses our GMP Agent-in-Place. 'She wouldn't accept a cup of coffee in the inspection room [...]