Drawing from over 20 years of industry experience, gain valuable insights and expert perspectives from a trusted microbiology quality assurance leader and internal auditor.
A specified organism is one that according to the pharmacopeia, cannot be present in a sample (usually 10g). These microbes are specified either as they may be an indicator organism (a microbe where its presence may indicate a pathogenic microbe could be present) or they may actually pose product safety concerns (whether by reducing the efficacy or posing a risk to the end user). Continue reading
One of the main International Standards used as a reference document in a sterile pharmaceutical microbiology laboratory is ISO13408 – Aseptic Processing of Health Care Products . Long ago, I reviewed the 1998 edition. The 2008 edition of the standard was last reviewed and confirmed in 2011 as current. Part 1 details the general requirements. The 2008 edition is edition 2 and is a techncial revision of the 1998 document. The guts of the standard are not dissimilar to version 1.
My review of the 1998 edition follows. When I get my hands on the 2008 edition, I’ll review that with reference to this review.
The use of italics is my way of emphasising points. Continue reading
Modified 20181212 – minor typos corrected. minor updates.
The USP is the United State’s Pharmacopeia. If you are selling pharmaceuticals in the USA, you need to follow the USP and are subject to FDA regulation. For the layperson, a pharmacopeia is an official publication containing a list of medicinal drugs with their effects and directions for their manufacturing, testing and use.
I last reviewed USP 1116 in 2009 when it was version USP31–NF26.
Where one does not have direct access to the USP (it is behind a pay wall), there are plenty of sites that review changes and publish their considered opinions. The USP itself publishes Revision Bulletins, IRA’s (public comment documents showing proposed changes) and Errata. From these one can build up a fairly accurate picture of the USP.
The latest iteration is USP 41–NF 36 — this became official on May 1, 2018. The last version I managed to get my hands on was USP36 NF31. What follows is my original review. Continue reading
When it was current, I reviewed the Australian code of good manufacturing practice for medicinal products (16 August 2002) so I was aware of the pertinent details in relation to viable environmental monitoring and testing.
The Australian Code of Good Manufacturing Practice for Medicinal Products 2002 was revoked effective from 1 July 2010 and replaced by the PICS Guide for Good Manufacturing Practice for Medicinal Products 2009, as adopted in Therapeutic Goods (Manufacturing Principles) Determination No. 1 of 2009. The 2002 GMP Code for Medicinal Products remains available here for comparison purposes. Continue reading