What you should know about the new ISO 80369-7 Standard
ISO 80369-7 is the newly published standard that replaces the ISO 595 series of standards. The ‘Part 7’ standard is [...]
Challenges of Microbiological Testing – Part IV – Complex Solutions
Often 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
The 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
Suitability 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
Controls, Validation, and Challenges of Bioburden Testing, Microbial Limits Testing, or Microbial Examination of Non-sterile products
FDA Guidance on Method Validation – Part One
Method 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
A 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