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Administrator
Posts: 578
Registered: ‎02-22-2010
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Deciphering Quality Assurance Procedures and Results Webinar

[ Edited ]

Thank you for joining our webinar with Eric Kastango, MBA, RPh, FASHP - "Deciphering Quality Assurance Procedures and Results from You Outsourced Sterile Compounding Vendor." 


View the recording or download the slides.

Have questions for Eric? Please post them here and he will do his best to answer.

Administrator
Posts: 578
Registered: ‎02-22-2010
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Re: Deciphering Quality Assurance Procedures and Results Webinar

Questions from the presentation that we did not have time to address in the live presentation:

 

Q: For sterility, is the expectation that each batch is tested? If not, what should be the appropriate sampling size?

Q: When do you think the RMM tests will start to become recognized as legitimate tests to utilize if they are quicker and maybe just as effective? (Like ATP testing for example)

Q: Are there methods available to check on concentration of a medication product?

Q: What happens after the compounder receives a 483?

 

Q: Did you state that vials may not be pooled in one test tube of growth media when using the direct innoculation method?

Expert
Posts: 1,166
Registered: ‎02-23-2010
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Re: Deciphering Quality Assurance Procedures and Results Webinar

Please find my responses (bolded) to your webinar questions below.  Thanks again for attending. 

 

Q: For sterility, is the expectation that each batch is tested? If not, what should be the appropriate sampling size? -->The expectation in the chapter is that each batch of drug that exceeds the default BUD or batches greater than 25 units of high-risk level CSPs are sterility testing according to USP 71.

Q: When do you think the RMM tests will start to become recognized as legitimate tests to utilize if they are quicker and maybe just as effective? (Like ATP testing for example)  --> I believe that RMM is already legitimate test, it needs to be validated by the user to be equivalent to USP 71.  USP is in the process of writing an informational chapter on RMM.  I have attached a slide deck from an USP meeting hosted the Microbiology Expert Committee.  It will give you some additional information on their approach

Q: Are there methods available to check on concentration of a medication product? --> Great question.  Shortly of having and using a HPLC or GC-MS machine, there aren't any "benchtop" devices that can analyze medications.  

Q: What happens after the compounder receives a 483? --> The FDA 483 is an observation of deficiencies that require a response/corrective action from the organization back to the FDA.  The FDA will either accept the corrective action plan or they won't which they can lead to additional inspections and if the FDA feels that the organization is not responding appropriately, the next step is a warning letter that can eventually lead to a cease and desist order.  

 

Q: Did you state that vials may not be pooled in one test tube of growth media when using the direct innoculation method? -->Yes, the issue with direct inoculation is that the sample volume being tested in each medium cannot exceed 10% of the total volume of broth.  Depending on the final volume of the containers being tested, it is not practical based on volumes of solutions.  We also need to make sure that the drug doesn't interfere with the test.  If the CSP can be filtered (suspensions can be filtered for this test), membrane filtration is the preferred method.  If you Millipore, Pall or Sartorius, these companies can help you figure out how to best sterility test your CSP. 

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.