With just over half a year to go until the divorce date, and roughly two months until European Chief Brexit Negotiator Michael Barnier’s self-imposed October deadline for a Brexit deal, it has started to feel like we are finally seeing some concrete progress when it comes to Brexit.
New requirements for control of elemental impurities went into effect at the beginning of 2018, replacing the longstanding requirements for heavy metals. Elemental impurities guidances are based on modern safety considerations specific to the elements identified.
This is the first in a five-part article series, Identifying And Resolving Errors, Defects, And Problems Within Your Organization. This article will enhance your understanding and prime you for visual detection of real trends in your organization by looking at a couple of examples. (You will understand the relationship between this picture and your quest for the quantitative truth by the end of this article.)
Finding a contract laboratory to fit the needs of your product is often challenging. Especially in the clinical and preclinical space, laboratory support is critical to presenting a foundation to the agency that your product is of the right quality and safety, and the basis of this before validation batches have been made depends wholly on the quality controls in place.
When looking at most job descriptions in GMP companies, they now require a college degree. This leads to the question: Are we overvaluing educational degrees and undervaluing experience in our hiring practices and position expectations?
Small to midsize pharmaceutical or biotech companies (small pharma) are enjoying the best of times. However, from a quality systems perspective, it could be the worst of times. Many have weak quality systems, are not following global regulatory authority regulations and/or guidance, or lack the level of documentation required to reconstruct every aspect of clinical trials.
This article describes the basic principles of inductively coupled plasma mass spectrometry (ICP-MS), which is one of the recommended techniques for carrying out the elemental determinations.
Are you ready to give the FDA more? “What?” you ask, as a manufacturer of API and finished goods. Are you ready to give them more data and information about your manufacturing process? You think, “Don’t they get all the necessary information from me during their inspections and from my filings?” Well, the answer is yes and no.
The draft guidance document provides recommendations regarding the testing for RCR during the manufacture of retroviral vector-based gene therapy products, and for follow-up monitoring of patients who have received retroviral vector-based gene therapy products.
The FDA recently issued for public comment six draft guidance documents intended to serve as part of a modern, comprehensive framework for how CBER will help advance the field of gene therapy. This article summarizes the first of those draft guidances, Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs).