Key Elements of a Bioburden Control Program, Monitoring Bioburden in Sterile/Non-Sterile Products
: 4 Nov 2019
Type: Training, Webinar, Seminar
Monitoring of in-process bioburden of pharmaceutical components, containers and closures, intermediates, drug substances and drug products are essential elements of the overall contamination control program for appropriate process control of both non-sterile and sterile products.
A typical bioburden control program includes review and analysis of potential sources of contamination commencing with each of the raw materials to include the Certificate of Acceptance of each. The microbiological contamination control program should be developed to identify and control bioburden and to assess product risk based on ICH Q9 Quality Risk Management. The bioburden risk assessment should result in the establishment of a range of critical control points which will ultimately lead to specifications for each raw material and to each unit operation as well as the drug substance and product.
This live interactive training webinar will help you to gain an enhanced understanding of the monitoring of bioburden, its inherent methods, and limitations to assure that the test is being applied as appropriate per United States Pharmacopeia and how to interpret the final result.
- Examination of a bioburden control program
- Major elements of a bioburden control program
- What a vendor can tell you through a COA
- What your bioburden evaluation is telling you
- What your bioburden is telling you about each unit operation
- How your bioburden impacts both non-sterile and sterile final products
- Interpretation of the results – regardless of a pass or failure
- Review of pertinent warning letters.