A) concepts in validation, analytical & process validation & iso 9000 series basic concepts of quality control & quality assurance systems control of quality variation of raw materials, containers & closures. Master in pharmacy (m pharm) all india council of technical education (aicte) and pharmacy council of india (pci) approved 2 years postgraduate programme offered by gupta college of. Mpharm dissertation thesis documents similar to m pharm_thesis_guidelines final 20141 process validation of polyherbal cough syrup formulation. Course duration: two years (semester system) course eligibility : bachelor degree in pharmacy with at least 60 % marks or equivqlent cgpa admission criteria: merit in qualifying examination, subject to eligibility criteria. View kalpesh dudhat's profile on linkedin, the world's largest professional community kalpesh has 5 jobs listed on their profile see the complete profile on linkedin and discover kalpesh's.
Home » opening for phd, mpharm, msc in research at iict | 33 posts opening for phd, mpharm, msc in research at iict | 33 posts indian institute of chemical technology (iict), hyderabad, a constituent of csir is a leading research institute in the area of chemical sciences. During process validation the process is kept constant ie step sequence, parameter settings, etc are fixed, while its inputs are varied between their extreme possible conditions the thought is if the output of the process subjected to such extreme conditions of its inputs is within acceptable limits, then the output of the process with. Depending on when it is performed in relation to production, validation can be prospective, concurrent, retrospective or revalidation (repeated validation) prospective validation is carried out during the development stage by means of a risk analysis of the production process, which is broken down. Validation protocol of ph meter a ph meter is an electronic instrument used to measure the ph (acidity or alkalinity) of a liquid (though special probes are sometimes used to measure the ph of semi-solid substances.
What is process validation process validation is defined as the collection and evaluation of data, from the process design stage throughout production, which establishes scientific. Question 1 (20%) in your own words, briefly describe your understanding of application of the lifecycle concept to validation process validation is a vital aspect not just for regulatory purposes, but also for the efficient and reliable long-term application of the process. The techniques outlined throughout the paper were used during the project and are based on industry standards and subject matter expertise for mechanical design, cleaning validation, sterilization validation and process performance qualification.
Validation procedures were carried out according to fda guidelines  as follows system suitability system suitability experiment was performed by injecting six consecutive injections using aqueous standard mixture equivalent to mqc concentration of the calibration curve. Works on process validation of cefadroxil monohydrate and submitted my thesis on the same for my mpharm degree as a vocational trainee for dissertation work lupin ltd, ankleshwar. Process validation is defined as the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product. Process in organic synthesis, pharmacology, cell and molecular biology, technology of fine chemicals and bulk drugs ± for btech pharmaceutical technology regulatory affairs in pharmaceutical industries and development and validation of.
The structure : with the results 1-mini-project descriptor part-1 (10%) elaborate in detail on a typical sequence of process validation activities for a. M pharm in pharmaceutical chemistry thesis title : chemical and pharmacological evaluation of justicia prostrata banaras hindu university, varanasi-221005, uttar pradesh, india. Malla reddy college of pharmacy 2013-14 10 256211886060 dharmender guvvali formulation and evalution of orlistat capsules dr k kishore kumar, m pharm, ph.
Research and development m pharm thesis 2011-12 pharmacology sr no project title name of student name of process validation and process optimization of. Mpharm,phd(prauge) this is to recognize and appreciate your contributions to the overall projecti am really impressed by your hard work and commitment, which is helping us in a big way to bring the project from infancy stage to the current stage. Validation report, statistical methods and tools for process validation, validation of tablet manufacturing process and manufacturing process for sterile products intellectual property rights: definitions, indian patent act & its amendments, patent. Educational qualification: mpharm, phd research area: analytical method development, validation, stability studies, impurity profiling, isolation, identification.
A validation protocol is a detailed document relating to a specific part of the validation process e g the oq for a manufacturing vessel it outlines the tests that re to be carried out, the acceptance criteria and the information that must be recorded. Syllabus for master of pharmacy (m pharm) effective from july 2011 (four semester full time programme) pharmaceutical drug regulatory affairs department of pharmaceutical sciences. Process validation of filling and sealing of parenteral product abhishesh kumar mehata mpharm , iit bhu,varanasi slide2: design qualification facility design area basic installation area for equipment varies accordingly to model and company requirements.