Power Failure in Aseptic Area

Power Failure in aseptic activity is most dangerous due to HIGH RISK to the product being prepare on line for patient safety. A high risk to product quality due to failure in sterility and non-viable counts.

There shall be always power back program for such activity and should be on Auto mode.

       

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How to prepare for inspection

How-to-prepare-for-inspection

Today handling inspection is very essential training and skill to newcomers in industry. Reading this article will help them for understanding of audit handling and how to reply an auditor for any query / question asked.

#dataintegrity is one of the biggest pain in #pharmaceuticalcompanies now a day and the issues are increasing year on year globally. Time to peep #within #rootcauseanalysis why is so.

Trends are eye opening and reveals, cases are growing around the globe more in last two Calendar years.

Link:

An-analysis-of-fda-warning-letters-citing-data-integrity-failures

Use These 7 Tools For Breakthrough Quality And Performance In 30 Days

To get best results in Quality people are using various type of tools. Here in this

article 7 Tools for quality performance are very well elaborated. Using such tools will definitely enhance quality system and make robust quality culture.

Link:

https://www.pharmaceuticalonline.com/doc/use-these-tools-for-breakthrough-quality-and-performance-in-days-0001?

Regulatory Expectations For Objectionable Microorganisms In Nonsterile Pharmaceuticals

Regulatory Expectations For Objectionable Microorganisms In Nonsterile Pharmaceuticals

We all know microorganisms are present in environment everywhere, in almost all type of conditions. Also this is known all microorganisms are not harmful only 2% of population is harmful and cause infections. 98% population of microorganisms are useful in running biodiversity on the earth.  Those are harmful comes under category of pathogens.

Likewise aseptic or sterile activity regulatory bodies are concerned about contamination of microorganism in formulation other than parenterals.

Crystal M. Booth has provided a good information in following article for non sterile microbiological contamination in formulation.

Regulatory-expectations-for-objectionable-microorganisms-in-nonsterile-pharmaceuticals-0001

How To Establish An Aseptic Gowning Qualification Program

How To Establish An Aseptic Gowning Qualification Program

For aseptic area control on contamination is most important and critical job. Gowning is not given to protect your body only, it is for protection of product from viable and non-viable contamination. Many studies has proven that HUMAN is the major source of contamination in clean area and therefore now close system are first choice of aseptic product manufacturing (RABS/ Isolator / SUS).

What are the best way of gowning and how to qualify them is given in details here in this article of  Crystal M. Booth, PSC Biotech.


https://www.pharmaceuticalonline.com/doc/how-to-establish-an-aseptic-gowning-qualification-program-0001

A review of - Advanced Microbiology Techniques for Aseptic Facilities

A review of - Advanced Microbiology Techniques for Aseptic Facilities

Here is link of video for everyone's update to know where Pharmaceutical industry is moving for - The Clean Facility of the Future - Advanced Microbiology Techniques for Cleaner Facilities and Purer Products.

This one of the good video having many industrial experts comments on the subject and will enhance knowledge to all who are in field of aseptic and clean area facility design, operation or quality checks.

Link:

A review of - Advance Microbiology Tech for Aseptic Facilities