Prashant Patil Email & Phone Number

To support and facilitate prevalidation, validation and troubleshooting batches forsmooth and timely launch of new products.· To identify critical quality attributes and controlling them with respect to criticalprocess parameters.· Planning and execution of site transfer and developmental projects (scale up, exhibitand validation batches) of different products with diversified manufacturing process.· Preparation of documents and reports (PEP, Scale up BMR, PER, Hold time report.)with respect to different batch size.· Monitoring of diversified validation batches (an alternate equipment, alternate batchsize, API equivalence etc).· Play’s a key role in investigation and failure batches, by preparing action plan,identify the root cause and provide relevant CAPA for it.Execution, monitoring and recording of trials, scale up, investigation batches in labnote book in prospective cGMP condition.· Involved in planning of trials and scale up batches with co coordination to R&D.(Project assessment, MFC finalization, sampling plan preparation, Materialavailability and indent by proposing relevant batch size as per the requirement andequipment’s capacity.)· Monitoring of Performance Qualification (PQ) for new equipments as per approvedprotocols and recording of data reports compilation.· Monitoring of scale up, exhibit and validation batches in view of criticality of processat shop floor.TECHNICAL COMPETENCIES:Knowing the operation of Production & formulations development equipment such as:-· Rapid mixer granulator: Gansons’s 50L/100L/600L/1200L, Sainath 250/600L andBowman’s 150 & 250 L· Roller Compactor: Fitzpatrick (IR 520 & IR4LX10D, Gerties macro pactor,Cadmach CMRC 200/150· Fluid Bed Process : Pam Glatt 125, 500 & 1300 L· Hot Melt Granulation : Leistriz· Compression machine: Korsch PH 800 & XL 800, ACG Pam Legacy 6100, Sejongtablet press (HRC), Cadmach (CTX 26,32,37).

Listed skills include Anda, Drug Delivery, Technology Transfer, Validation, and 20 others.