Knowledge of the critical activities and success factors required for an effective and efficient technology transfer.Knowledge that the physical and chemical attributes of the product have implications in production.Knowledge of the impact of methods of measurement and control on product and process quality and stability.Knowledge of the impact of the processing, storage, and transport environments on ingredients/materials and semi- and finished goods.Knowledge of the production process and the role of interactions of ingredients/materials employed in pharmaceutical development and manufacturing.Knowledge of the impact of decisions (for example, dosage forms, batch size, production method, outsourcing) during drug development on product lifecycle viability and success.Knowledge of the purpose and conduct of clinical trials Phases I, II, and III.Knowledge of functions and pathways involved in product development.Formulation, Clinical Phases, and Manufacture
Through the interactions of multi‐disciplinary functions and the scientific application of experimental design methodologies, implement a process to reproducibly and economically manufacture a product of (a) the desired formulation, dosage form, and specifications that meets predicted quality (b) is optimized for purity, potency, and efficacy and (c) facilitates continuous improvement. Knowledge Element 1 - Product Development The CPIP examination was based on the following body of knowledge, known as the 7 Technical Knowledge Elements of the CPIP Credential. Certified Pharmaceutical Industry Professional Body of Knowledge In January of 2015, the transition of ISPE’s certification program was complete and those who had achieved certification in the CPIP program were awarded permanent certificates recognizing their achievement as Certified Pharmaceutical Industry Professionals. In September of 2013, the ISPE Board of Directors made the decision to close the CPIP program to new applicants after November 30, 2013, permitting those already engaged in preparation to complete the certification by June 30, 2014, and permitted those who held the CPIP credential to retain the credential. The credential was awarded to qualifying candidates during the period July 2007 through September 2013. The CPIP credential was awarded to eligible candidates who met the education and Industry experience eligibility requirements and successfully passed a 150 question multiple-choice examination. The Certified Pharmaceutical Industry Professional (CPIP) credential is a professional certification program for the pharmaceutical industry covering product development through manufacturing.
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