Help Achieve Compliance With Regulatory Standards

USP General Chapter <797> – Sterile Preparations

Section 2.0 – 'Personnel who compound or have direct oversight of compounding personnel must be initially trained and qualified by demonstrating knowledge and competency... initially and at least every 12 months in appropriate sterile compounding principles and practices…'

Section 20 – 'All facilities where CSPs are prepared must have and maintain written or electronic documentation to demonstrate compliance with the requirements in this chapter. This documentation must include, but is not limited to, the following: Personnel training, competency assessments, and qualification records, including corrective actions for any failures…'

FDA cGMP – 21 CFR

Section 211.25(a) – 'Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions.'

FDA Guidance for Industry (2004)

Section V.B – 'The basic principles of training, aseptic technique, and personnel qualification in aseptic manufacturing also are applicable to those performing aseptic sampling and microbiological laboratory analyses. Processes and systems cannot be considered to be in control and reproducible if the validity of data produced by the laboratory is in question.'

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