– XI. The PMA approval is primarily based on the protocol AI-001 conducted under the IDE study (G100259). However, it may not be necessary to examine specifically for certain degradation products if it has been demonstrated Stability Protocol shall be prepared for all batches, which shall be charged for stability study. The used protocol to study photodegradation of FA in this work was that published by Welankiwar et al. Download the Draft Guidance Document Read the Federal Register Notice. Examining degradation products under stress conditions is useful in establishing degradation pathways and developing and validating suitable analytical procedures. Study of product quality under the infl uence of light is called photo stability . Stability study protocol shall be prepared as per Annexure No. stability study protocol template Published by PharmaState Blog This is a platform for people working in the pharmaceuticals industry for Discussions, Jobs, News updates, Professional Profile display space and company business pages. Protocol shall … Exposures often vary by several orders of magnitude, making comparative studies difficult. Not for implementation. Photostability testing should be an integral part of stress testing. The data is Photostability testing by strong light: Open the loaded container and place it in a light cabinet or other suitable light device. Guidance for Industry Q1B Photostability Testing of New Drug Substances and Products Additional copies are available from: the Drug Information Branch (HFD-210), photostability characteristics should be confirmed on a single batch selected as described in the Parent Guideline if the substance is clearly photostable or photolabile. Q1B Photostability Testing of New Drug Substances and Products March 1996. If the results of the confirmatory study are equivocal, testing of up to two additional batches should be conducted. The substance being examined should be exposed to light of 4500 lx ± 500 lx for 10 days sampling at the fifth and the tenth day … testing.. ... Confirmatory studies are those undertaken to establish photostability. of the guideline, photostability protocols varied considerably with regard to the types of photolysis sources and their spectral characteristics, specimen presentation, exposure duration, etc. The adoption of Q1B set minimum requirements for test protocols The protocol covers stations (time intervals) and tests required during the stability studies of that product. Prior to the initiation of the AI-001 study, the device had been implanted in the US in 64 patients through compassionate use requests. 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