About the Instructor Dr. Ramakrishnan Narasimhan, Technical Director. FSPCA Certificate of Training. A versatile food safety professional with indepth technical. GMP Training. Popular and wellrespected. Offering the most choices in GMP training services and trainer support. The worlds leading networking information sharing website for food safety practitioners. This table does not represent the complete set of 483s issued during the fiscal year as some 483s were manually prepared and not available in this format. Issuu is a digital publishing platform that makes it simple to publish magazines, catalogs, newspapers, books, and more online. Easily share your publications and get. Latest News Regulatory Recon FDA Approves Otsuka, Proteus Digital Pill Janssen Drops Suit Against Samsung Bioepis Remicade. All the Meath jobs from Irelands main job websites. Overview Of Generic Formulation Development For US Market by Omkara Swami Muddineti. Selection and qualification of vendors for API, RM, PM. Procurement of innovator products. Procurement of API, RM, PM. Analytical method development assay, RS, dissolution, UOD and validation. Literature review regarding patents. Selection of filing Para I para II para III para IV. Planning of development strategy. Selection of excipients vendors API Vendors PM vendors. Design of experiments in small scale X. Finalization and reproducibility of formula in size approx. X. 1. 3. Scale up approx. X. 1. 4. Charging for stability. Process optimization and validation. Validation batches 1. X. 1. 7. Bioequivalence studies. Preparation of protocols. Filing Procedure and Duration. Departments involved and their role 1. Intellectual property rights Patent infringement is a very big issue in generic product development. It involve in collecting the information from patent searching databases for a particular product. Detailed interpretation will be done on the product so that infringement should not happen during product filing. Formulation R DIt involves in the development, optimization of the formulation for the innovator product. The sequential flow of the activities are as follows. O Literature searches and review of the Reference listed drug RLD chemical, pharmaceutical, pharmacological, pharmacokinetic and patentsO Reverse engineering of RLDs and check for inactive ingredients IIG limits, office of generic drugs OGD dissolution database. O Identification of new raw materials. O Performing preformulation studies of the physical and chemical nature of innovator drug products. O Characterization of pharmaceutical components physical, chemical, pharmaceutical, pharmacokinetic and drug substances prior to formulation. O Identify and evaluate the critical formulation factors e. O Identify and evaluate Quality target product profile QTPP, Critical quality attributes CQA, Critical process parameters CPP and critical material attributes CMA. O Coordinate development with AR D, Engineering, Validation, Production, Non clinical, Clinical, Regulatory, and QA, to ensure uninterrupted progress. O Design and development of prototype trials. O Documentation of product development activities. O Develop manufacturing process and prepare c. GMP and non GMP batches. O Conduct Qb. D and Validate processes for the trial batches. O Prepare process evaluation, scale up, execute batches as per the protocols, analyze data, and prepare summary reports. Understand material characteristic and product quality attributes thoroughly and identify the most suitable processes to manufacture the product meeting all intended quality attributes. O Suggest process improvements, perform trouble shooting and changes to improve quality. O Prepare project summary, reports and presentations and make recommendations to managements. Analytical R DAnalytical R D involves mainly evaluation of the formulation sent by formulation, production and quality assurance department during the product development. The key activities are as follows. Pre formulation Studies. O Design of preformulation protocols, review and monitor drug excipient, drug compatibility studies. O p. H dependent solubility profiles. O Intrinsic solutbility. O Hygroscopicity studies etc. Stability Studies. O Design, Review and approval of stability protocols. O Plan and Monitor Stability Studies as per ICH Guidance conditions or specified conditions. O Plotting of Trend Charts. O Review of Reports, Investigation of Incidents, OOS, OOT and Investigation. Analytical Method Transfer. O Lead Transfer of Validated analytical Methods to customer QC, Manufacturing Sites as per specified protocols. Raw Materials Analysis. O Monitor and Review Analysis of Raw Materials as per Pharmacopoeial Requirements. Equipment Calibrations. O Ensure Equipment or Instrument Calibration as per Master Calibration Schedule and Compliance. Good laboratory practice GLP O Ensure the Laboratory complies to the current GLP. Technical Requirements. O Expertise with working on Analytical Instruments like HPLC, GCHS, Dissolution Tester, UV Vis Spectrophotometer, Titrators etc. O Possess excellent Troubleshooting Skills, Guide, Train and work with the Team in situations of Crisis. O Develop and validate analytical methods for finished products for regulated markets US and Europe marketO Handling equipments like HPLC, UPLC, dissolution tester, UVVis spectrophotometer, IR, KF titrator etc. O Trouble shoot in existing methods and support regular and stability analysis for formulation development. O Preparing reports like method development report, validation protocols and reports, specifications, stability protocols etc O Following good laboratory and documentation practices O Preparation of Instrument and system SOPs for development. Quality assurance 1. To establish the quality system. O Establish the quality management system to describe how the firm follows CGMPs and operates to maintain a state of control. O Keep the quality management system current with good industry practices, and applicable to the mission of your operation. To audit compliance to the quality system. O Audit for compliance to policies and procedures on paper vs. O Report quality system performance metrics, including trends, that help decision making and taking proactive targeted actions. To establish procedures and specifications. O Ensure that procedures and specifications are appropriate and followed. O Ensure that the procedures and specifications of firms under contract are also appropriate and followed, i. To establish manufacturing controls. O Ensure that appropriate manufacturing in process controls are implemented. O Ensure in process controls are performed during manufacturing operations and results are satisfactory 1. To perform laboratory tests or examinations. O Perform laboratory testing of components, containers, in process materials, packaging materials and drug product using validated methods against scientifically derived, fit for purpose specifications. O Approve or reject drug products manufactured, processed, packed, or held under contract by another company, i. O Perform retests or reexamine approved components, drug product containers and closures after long storage or exposure to adverse conditions 1. To review and approve or reject all things c. GMPO Review and approvereject any document that gives work instructions and set requirements such as procedures, protocols, test methods, and specifications including changes to these documents. O Review and approvereject reprocessing and rework procedures. O Review and approvereject production batch records and make the final decision to release a product lot into commerce. To ensure investigation of nonconformance. O Ensure investigation is conducted and root cause is eliminated for production and control record errors, discrepancies, and failure to meet specification, including quality attributes. O Review complaints to determine if it relates to a failure to meet specification, if so investigate and report to FDA if it is serious and unexpected. To keep management informed. O Report on product, process and system risks and keep management informed. O Report on outcome of regulatory inspections and ensure responses are complete and managed to verifiable closure and keep management informed. O Keep management informed get it