Successful product validation depends on operational readiness: facility and equipment, development knowledge with thorough analytical and process design documentation, trained cross functional staff at the manufacturing site and a robust formulation and process. Prior to the validation phase, successful technical transfer must be completed with robust information transfer from development to manufacturing. The validation process is used to substantiate the manufacturing process documents, which contains the control strategy of the drug product and the boundary limits of the process consisting of limits of processing variables. Key process parameters (KPP), critical process parameters (CPP) and critical quality attributes (CQA) are used to define the drug product process control strategy. Validation is performed at the target parameters. All other studies to assess the boundary limits must be done prior to validation.
Principal Consultant, CAI
Mr. Moreno has over 34 years of Pharmaceutical Manufacturing experience in aseptic processing, technical service and drug product development; most of which was at Eli Lilly and Company. He developed several drug product dosage forms including oral solutions, Blow-Fill-Seal sterile inhalations and parenteral liquid and freeze-dried presentations: Responsible for devising and performing lab studies to determine the formulation and process leading to clinical supply and final commercialization phases, and supporting process/product boundary parameters. 10 years as a technical service representative for parenterals (small and large molecule dosage forms) with considerable engagement with operations, quality and engineering for continuous improvement and CAPA remediation.
Mark is experienced in technical transfer exercises including scale-up activity, master batch record, validation and control
strategy design and reports. During his career as a pharmaceutical scientist, he gained considerable knowledge with the
formulation of freeze-dried formulations and freeze drying cycle development, including freeze drying microscopy. Experienced in manual visual inspection equipment, inspector qualification and methods for current regulatory expectations.