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Sources

1. FDA Guidance for Industry. Q10 Pharmaceutical Quality Systems. April 2009. https://www.fda.gov/media/71553/download

2. International Council for Harmonization. Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. November 2019. https://database.ich.org/sites/default/files/Q12_Guideline_Step4_2019_1119.pdf

3. Diane Harper, Applying ICH Q12 to Combination Products. American Drug Delivery & Formulation Summit. 2019

4. Susan Neadle, Combination Products GMP and Controls Strategies. Xavier Health Combination Products Conference. 2018

5. Julien Klein, Developing a Combination Product Control Strategy. PDA Europe Prefilled Syringes Interest Group Webinar. 2021

6. Nuha Al-Hafez, et al., Holistic Control Strategy: From ICH Quality Guidelines to Pharma 4.0. ISPE Pharmaceutical Engineering. 2021

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Fran DeGrazio

Fran DeGrazio

Chief Scientific Officer

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