How do we know the pellet product processes are going to meet quality expectations?

Implant Technology, LLC (ITRI) provides a licensing program for pharmacies interested in pellet implant therapies. ITRI was developed by Dr. Samuel Alawieh, PharmD to address the needs of expanded care options in pellet therapy, as well as improved process efficiencies. This company is comprised of individuals that have been trained and coached by Dr. Alawieh to deliver the highest quality procedures, supplies, and equipment for pellet production. Our team offers expertise in laboratory processes, formulations, customer care, regulatory compliance and much more. These individuals are dedicated and governed to implement services and provide products synonymous with our high quality standards.

What is the process used to make pellets and how is staff trained?

We are constantly updating our technology to ensure consistently high quality pellet production. The latest is a state of the art pellet machine designed to compound pellets, with safety sensors in place to detect process failures. For example, if the chemicals were not weighed correctly, the compounder could not operate the machine. We are using custom designed software to ensure that the formula is compounded properly. If any component of the process is missing, the compounding process will not take place. This will assure quality control without requiring extensive oversight of lab personnel.

An extensive compliance program is in place to ensure that the standard operating procedures are properly trained followed in daily process. Pharmacies and staff are offered training programs, webinars, and a training manual, followed by comps to ensure that the compounder understands every aspect of the pellet process. Our compliance personnel will examine the process bi-annually to warrant that the process is consistently being followed, tested, and delivered safely.

A cloud-based application was designed to streamline management of the front-end order process and customer care aspects. Clinicians can log in to an online application and see where their order is in the process, and communicate with the pharmacy.

ITRI is committed to delivering the best equipment, supplies, and expertise to meet the needs of our licensees. Through research and development we endeavor to stay on the cutting edge of pellet implant technology, delivering resources and training to our licensees.

What is your testing process for pellets?

Our custom made implant pellet process specifies compliance practices to USP-797 and ISO-Class 5 clean room regulations, exceeding the standards required for sterilization and quality.

Our resources provide for non-bias testing from independently registered FDA testing labs to promise sterility and potency with each and every batch made available using our custom, cloud-based CRM application..

A standard operating procedure has been developed and will be implemented by our Compliance Department to ensure that the ITRI licensees adopt the process as part of their QA/QC.

What is your rule on testing your products and how do we have access to it?

All batches must go through dissolution test associated with day-to-day validation testing on any device that may affect the sterility of the final product. Also 3rd party testing for an analytical testing facility is required at different intervals, to validate the process. Internal and external testing results could be easily viewed online or requested by fax or email.

Who are your suppliers and how do we know they are safe?

Our affiliate, Sterile Labs, supplies lab equipment, raw materials, and lab supplies to address all needs related to pellet production. As part of the compliance program, each product ordered accompanies a material safety data sheet. Raw ingredients are randomly sent for testing for sterility and potency. We vigorously follow the FDA for Drug Safety Information, and any recalls that have taken place. All distributors must comply with cGMP and NABP accreditations.

If a problem arises, for example, broken pellets, quality issue, who do you contact? Who can address patient concerns?

ITRI has a full time dedicated client support team that has extensive experience in pellet production and will address any quality concerns regarding pellets. Our pharmacists and physician experts are also available to offer support as it relates to patient specific concerns.

Do you have patient education materials we can share with our patients to ensure that they are comfortable with using compounded medications?

We have product information sheets available for each of the hormone compounds used in our formulations. We also have patient information in the form of answers to frequently asked questions. All of this information, and more, is available on our website and in the manual provided.

What is the chain of command process for pellet quality control? And how do you manage chain of command?

The chain of command is provided and implemented by our dedicated pharmacists and quality control staff to ensure that every pellet compounded passes our extensive testing process to ensure sterilization and potency and uniformity. All batches go through a vigorous requirement to meet all compliance needs and personnel take part in these roles to ensure quality and safety.