Reconciling Quality and Price When Choosing a Sterile Compounder

In the high-risk sterile compounding world, quality is absolutely critical.  Providers should demand quality compounded products and patients deserve quality compounded products. But, while quality is a word that is used often, it can be extremely difficult to truly grasp what it takes to produce the highest quality sterile products. I believe, if you ask physicians and nurses, they will say quality is extremely important in choosing a sterile compounder.  Yet, when it comes to choosing what compounder to use, all too often the question of price comes first. Price has to be a factor but, if the product is not safe, choosing the wrong sterile compounder can be extremely expensive.

So, how do you make sure you are getting the absolute highest quality product at a fair price?  The answer is due diligence.  You must thoroughly qualify your compounding provider.  Now that the Drug Quality and Security Act (DQSA) has passed, there is a higher standard in place for sterile compounders that choose to register as an Outsourcing Facility with the FDA.  But verifying that your compounder is registered with the FDA is just the first step.  Do not stop there when doing your research.   Ask your compounder these questions:

Environmental Monitoring

Do they have an automated system in place to continuously monitor the pressure, temperature and humidity in the clean room?

How often do they conduct environmental monitoring for viable and non-viable particulate counts in the clean room)?  (Monthly is good.  Weekly is better.)

Are the aseptic processing personnel tested daily for fingertip contamination?

 

Employees

How do they train their employees? (Ask for specific examples)

Do the aseptic processing personnel wear all-sterile garb?

Do the aseptic processing personnel have any exposed skin while working in the clean room?  (A hair net, mask and gown is good but complete sterile garb with no exposed skin is much better.)

 Process Validation

Does your compounder have a Validation Master Plan?

Does all equipment have supporting documentation that is in working order and is all equipment checked and certified on a regular basis?

Has Installation Qualification been performed and documented?

Has Operational Qualification been performed and documented?

Has Performance Qualification been performed and documented?

 Product Testing

Does your compounder have stability and sterility studies for their compounds that they will openly share with customers

Will they share the sterility and potency tests for products they send you?

 Quality Assurance

Will they supply quarterly Quality Assurance reports?

How do they address audit requests?

Do they allow unannounced audits?

How many audits did they have last year?

Were there any unfavorable reports?

Have they been inspected by the FDA?

By asking these questions and carefully evaluating a high risk sterile compounder, you can make an informed decision.   You deserve to rest easy knowing that your compounder spares no expense in producing sterile products of the highest quality.

 

JCB Labs – helping you protect your patientss.

Written by Newport Beach Compounding Center Staff

As one of the most experienced compounding pharmacies in Newport Beach, We provide a valuable service working together with physicians and patients to create medications tailored to specific requirements. We are specialists in the art and science of pharmacy compounding. Our Team of experts can meet all of your unique pharmaceutical needs.

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