Pharmaceutical Microbiology Resources. Edited by Professor Tim Sandle (established 2009)
The US Food and Drug Administration (FDA) has issued a draft guidance entitled ‘Computer Software Assurance for Production and Quality Management System Software’. Aimed at medical device manufacturers - check this out and other recent regulatory updates: https://www.rssl.com/insights/life-science-pharmaceuticals/issue-42-pharmaceutical-regulatory-roundup/
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)
Monitoraggio microbiologico ed Annex 1. Intervista a Tim Sandle
In the new Annex 1, microbiological contamination from materials entering the cleanroom is provided with a far greater emphasis. This has been identified as one of the major routes of contamination for items coming into the facility. The optimal means of transfer is via a double-ended autoclave and using moist heat. Where this is not possible, of where single-use sterile items are required, then a disinfection process is required. This can be automated (as with a decontamination chamber using a vapour like hydrogen peroxide or chlorine dioxide) or a manual process using a transfer hatch equipped with a localised HEPA filter air supply.
AM Instruments incontra Tim Sandle sui principali temi del nuovo Annex 1: processi di sterilizzazione, monitoraggio microbiologico, trasferimento dei materiali, isotecnia e contenimento, cleaning e disifezione e, per concludere, la disinfezione delle mani.
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Also available: https://www.aminstruments.com/annex1-trasferimento-materiali-timsandle/
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)
The European Medicines Agency (EMA) has published a set of comments raised in relation to its draft guideline on quality requirements for drug-device combinations.
The guideline describes the information that should be presented in the quality part of a marketing authorisation dossier for a medicinal product when it is used with a medical device. The guideline focuses on product-specific quality aspects of a medical device (integral, co-packaged or separately-obtained and referenced in the product information) that may have an impact on the quality, safety and efficacy of a medicinal product.
The comments can be found here: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-quality-water-pharmaceutical-use_en.pdf
The main document can be accessed here: https://www.ema.europa.eu/en/quality-documentation-medicinal-products-when-used-medical-device
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)
The document is titled: ‘Field Alert Report Submission: Questions and Answers Guidance for Industry’.
The introduction states: “This guidance provides FDA’s current thinking regarding the requirements for submission of field alert reports (FARs) by applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) and outlines FDA’s recommendations for FAR submissions to help improve their consistency and relevancy. The guidance also addresses certain frequently asked questions.”
See: https://www.fda.gov/media/114549/download
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)