What you should know about the new ISO 80369-7 Standard
admin 2018-04-12T21:09:51+00:00ISO 80369-7 is the newly published standard that replaces the ISO 594 series of standards. The ‘Part 7’ standard is specifically [...]
Challenges of Microbiological Testing – Part IV – Complex Solutions
admin 2018-05-10T07:13:26+00:00Often in the microbial examination of products, physical issues occur that force adaptations to the sample preparation. Some of these challenges include viscosity, the need for mixing or blending to a
Challenges of Microbiological Testing – Part III – Inhibitory Products
admin 2018-05-10T07:13:26+00:00The microbiological examination of products can often prove challenging when the product is antimicrobial. This is often by design, but can also be inherent to the excipients, inherent to the active p
Challenges of Microbiological Testing: Part II – Suitability Testing
admin 2018-05-10T07:13:26+00:00Suitability Testing is integral to any Microbiological test system. Suitability testing demonstrates that the test system and methodology are suitable for the intended purpose and compatible with the
Challenges of Microbiological Testing: Part 1- Controls and Validation
admin 2018-05-10T07:13:26+00:00Controls, Validation, and Challenges of Bioburden Testing, Microbial Limits Testing, or Microbial Examination of Non-sterile products
FDA Guidance on Method Validation – Part One
admin 2018-05-10T07:13:27+00:00Method Validation effects the development and quality control testing of most products. Updated FDA guidance titled Analytical Procedures and Methods Validation for Drugs and Biologics
A Candid Look at the Contract Pharma Conference
admin 2018-05-10T07:13:27+00:00A few months back I published a blog article on the value of attending Interphex. For the regular readers (I know there are few), you will recall that I started that article by simply stating my dista