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INDUSTRY RESOURCES

06
Aug
Education Vs. Experience: Which Is More Important In GMP Operations?

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?

Posted in:Manufacturing,
31
Jul
1
10 Key Ingredients For Small Pharma GCP Quality Systems

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.

Posted in:Clinical,Manufacturing,
Tags:big pharma,GCP,quality systems,small pharma,sponsors,vendor oversight,
30
Jul
An Introduction To Inductively Coupled Plasma Mass Spectrometry For Measuring Heavy Metals In Pharmaceuticals

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.

Posted in:Manufacturing,
27
Jul
FDA And Quality Metrics: Where Do Things (Currently) Stand?

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.

Posted in:FDA,Manufacturing,
Tags:API,inspections,quality metrics,
25
Jul
FDA’s New Guidance On Replication Competent Retrovirus Testing During Gene Therapy Manufacture

The draft guidance document provides recommendations regarding the testing for RCR during the manufacture of retroviral vector-based gene therapy products, and for follow-up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.

Posted in:FDA,Manufacturing,
Tags:CBER,gene therapy,genetic sequence,
23
Jul
FDA’s New Guidance On CMC For Gene Therapy INDs — What You Need To Know

The FDA recently issued for public comment six draft guidance documents intended to serve as part of a modern, comprehensive framework for how CBER will help advance the field of gene therapy.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).

Posted in:FDA,Manufacturing,

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