Pharmaceutical compounding involves the preparation of medications tailored to the specific needs of individual patients. However, the process of pharmaceutical compounding is complex, and the products must be sterile and meet strict quality standards. The USP <797> guidelines set out the requirements for sterile compounding, and a designated person is responsible for ensuring compliance with these guidelines.
At Aseptic Enclosures, we provide comprehensive Compounding Training Services and Support for all personnel operating in compliance with the USP <797> and support for the designated person responsible for ensuring compliance with USP <797>. Our training program is designed to equip the designated person with the necessary knowledge and skills to carry out their responsibilities effectively.
Compounding training services and support for Cleanroom Dedicated Person
One of the unique features of our continuous support program is that we provide all the tools, methods and resources that will assure fulfilment of the designated person role.
Some of the key responsibilities are outlined below.
One of the key responsibilities of the designated person is to confirm the appropriateness of sterilizing filters. Our training program provides in-depth knowledge of the various types of filters, their appropriate use, and how to evaluate their effectiveness. This knowledge is critical to ensure the products are sterile and safe for patient use.
Another responsibility of the designated person is to ensure that appropriate air classification requirements are met. The designated person is also responsible for ensuring that corrective actions are documented and taken if deviations, errors, failures, or problems are identified. Our training program provides guidance on how to identify and respond to deviations and errors, including the implementation of corrective actions. This is critical to maintaining the quality and safety of the products.
Formal, written quality assurance and control programs must be established to ensure compliance with USP <797>. The designated person is also responsible for ensuring that International Organization for Standardization (ISO) 5 areas are located, operated, maintained, monitored, and certified to have appropriate air quality.
Standard operating procedures (SOPs) must be appropriate, implemented, reviewed, and documented at least every 12 months to ensure they reflect current practice and are revised and documented when necessary. Our training program covers the development, implementation, and maintenance of SOPs to ensure they are up-to-date and effective. We also provide some templates and guidance on developing of almost fail proof SOPs.
Those entering the sterile compounding area must maintain the quality of the environment, and the designated person is responsible for evaluating whether an exception may be made to personnel preparation requirements when entering the sterile compounding area.
The designated person is also responsible for investigating temperature excursions, overseeing the personnel training program, reviewing all certification records, and selecting an appropriate and reliable source for components that cannot be obtained from an FDA-registered facility. Our training program covers all of these responsibilities and provides the necessary knowledge and skills to carry out these tasks effectively. We often extend our training program to assure that the designated person is ready to carry on by themself.
Aseptic Enclosures’ Compounding Training Services and Support for Designated Person
Our support for designated persons goes beyond training. We provide ongoing support to ensure that they have the necessary tools and resources to carry out their responsibilities effectively. Our team of experts is always available to answer any questions, provide guidance, and offer solutions to any problems that may arise during the compounding process.
In conclusion, Aseptic Enclosures provides comprehensive training services and continuous support for the designated person responsible for ensuring compliance with USP <797>. Our designated person training program covers all of the key responsibilities of the designated person, providing the necessary knowledge and skills to maintain the quality and safety of the products.
We offer comprehensive training and support for designated persons responsible for complying with USP <797> requirements. Our training programs cover a broad range of topics, including sterilization techniques, air quality monitoring, corrective actions, quality assurance, and control programs.
We understand the importance of maintaining a sterile environment in the compounding area, and as such, we provide extensive training on air classification requirements, monitoring, and maintaining the appropriate air quality. Our training programs also cover the evaluation of personnel entering the sterile compounding area and the exclusion of individuals with certain conditions that may compromise the quality of the environment.
Read more about USP established role of Designated Person within a cleanroom
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Nicely written, clear and concise.
Thank You!