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Question-based Review (QbR) is a format proposed by United States Food and Drug Administration (US FDA) enhancing the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use's Common Technical Document (ICH CTD) format to streamline the submission process. It is a question–answer format applied to Quality Overall Summary section of the submission. The format includes putting up questions under every section, so the applicant can submit precise and accurate data for approval of the respective application. The QbR format can be applied to NDA, ANDA, and Type II DMF applications. The companion document available with Manual of Policy and Procedures 5015.10 (MaPP 5015.10) allows the reviewer to inspect the critical information in the data provided. It encourages applicants to encompass Quality by Design (QbD) in their development process. QbR gives a structure through which the data collected by applying QbD can be presented. For effective application of QbR format, the submission should be backed with thorough scientific knowledge, risk assessment data, and data integrity. The questions asked compel the applicant to provide justification for the various decisions made in the development phase. Also, questions regarding quality target product profile, critical quality attributes, critical material attributes, critical process parameters and design of experiment are covered under the QbR format. MaPP 5015.10 finalized by US FDA in 2014 clarifies the concept of QbR. There is MicroQbR available which includes questions confirming the sterility of the product. QbR is a step towards speeding up the review process with an intention to motivate the applicants to implement QbD to the project.

Oil is one of the important formulations in Ayurveda for external as well as internal use. In this study, an evaluation of the commercially available Mahamasa, Mahanarayana, sesamum oil was conducted using two different chromatographic Technique (traditional & modified pre chromatographic TLC).HPTLC is an important designing tool to evaluate the oil sample .But sampling strategy of oil in the context of traditional chromatographic method is very lengthy, costly and less convenient. Here we have modulate the chromatographic method with respect to continuous improvement plan(Kaizen approach) such as need based acceptation of saponification and paradigm shift of direct application of oil on TLC plate. Direct application of oil on plate concept adopted from pre-chromatographic derivatization, which oil sample direct applied on TLC plate and developed with suitable solvent system, and during development only unsap material will we separate on TLC plate and then compare with traditional method outcome. Separation pattern of oil on plate are same both method traditional and modified method. That means separate operation will not require for oil separation like hydrolysis of oil, extraction of unsaponifiable material and sample preparation. However modified method is less time, chemical consuming and more convenient for economically chromatographic evaluation of oil sample.

Objective : To establish an acceptable identification system of various purification effects in context classical based different media on turmeric samples and relates its altering pattern in favor of phyto-pharmacognostical, image processing and multivariate chemometric analysis. Methods: Authenticated turmeric samples purified through different processes by using different media such as cow’s urine, panchapllava (five different plants tender leaves), the inflorescence of alambusha ( Sphaeranthus indicus , Linn) decoction, water and buttermilk. Resultant samples dried, pulverized and undertaken powder microscopy, image processing, physicochemical and chromatographic fingerprinting (HPTLC). The multivariate chemometric analysis, principal component analysis (PCA) analyzed with help of Unscrambler and image processing in Matlab software. Results: The addition of characters of medias drug with turmeric powders like the crystal of gomutra, pollen grain and starch grain of Alambusha, epidermis, fibre, the crystal of panchapllava. Identify different perceivable colors in variously processed turmeric by analyzing the Lab color space through the Image segmentation. PC 1 and PC 2 explained (90 + 9) % total variance in score plot of respective purify turmeric samples shown clear grouping in relation to the physicochemical constant. Quantification of curcumin in various treated turmeric samples displayed variation due to additive effect in high-performance thin layer chromatographic profile. Conclusion: This study proved that purification in ayurveda not only refers to the elimination of toxins and unwanted particles but also the transformation in the properties in the primary substance rendering it safe as well as many desired qualities are imbibed in it.

Objective: To establish a noticeable and a justifiable identification system to assess the impact of shodhana (processing) on various levels of Baliospermum montanum (Danti) root samples obtained through shodhana (processing technique) in quality agreement based on near-infrared-spectroscopy. Methods: Authenticated raw Danti (R. D) root and various Danti root samples obtained after shodhana (processing) such as water processed Danti root (WPDR), Kusha processed Danti root (KPDR) and classical processed Danti root (CPDR), were dried, pulverized and shifted through eighty meshes. The samples were subjected to NIR spectral detection from 750 to 2500 nm at the interval of 1 nm. The multivariate analysis, principal component analysis (PCA) and hierarchical cluster analysis (HCA) analyzed with the help of Unscrambler and Matlab software. Results: Direct spectral analysis indicated the existence of significant numerical and graphical differences between Danti root samples containing different treatments during processing in respect to CH, OH and NH functional groups. The multivariate PCA algorithom plot allowed a clear segregation of the Danti root samples after various data preprocessing technique onto the hotelling T2 95% confidence limit for principal component 1 and 2. The cluster analysis had shown the extra information on the metabolite profiling of the complex purificatory environment. Conclusion: The present study demonstrates a generic, non-destructive solution to discriminate qualitatively in the sample matrix all the differently pretreated samples in favor of the NIR-sensitive functional group.

Objective: The combination between the stem bark powder of Chirabilva and Veerataru is used ethno folklore for the management of anti-convulsion by tribal people. To standardise the evidently used polyherbal formulation in a systemic way for supporting the identity, quality, purity, safety and efficacy concern with modern technique. Methods: Microscopic anatomical examination and powder microscopy were performed fresh and dried plant materials respectively. The compound polyherbal formulation is processed by organoleptic characterization, macro-microscopic evaluation, physicochemical, phytochemical testing, DNA fingerprinting and high-performance thin-layer chromatography (HPTLC) profiling employing a standard methodology. Chromatographic fingerprinting after visualisation the data are exploited by multivariate chemometric technique. Results: Results of the experiment provided diagnostic characteristics to identify quality and purity and standardise the polyherbal formulation along with respective ingredients. The RAPD analysis of Dichrostachys cinerea and Holoptelea integrin folia showed some similar bands at the same base pair indicate the presence of genetical identity may take into consideration of the control the ingredients. HPTLC technique utilised to distinguish the ingredient and polyherbal formulation based on the presence or absence of certain target phytochemical (flavonoid, polyphenol, etc.) constituents, manifested as peaks or bands from the chemical fingerprint profiles. Visualized chromatographic profile of polyherbal formulation along with its constituents applying the multivariate chemometric technique is easily discriminated of respective retardation factor in principal component score space. Conclusion: The findings from this study will provide systemic evaluation for this anticonvulsant formulation and also serve as a master document to control the quality of polyherbal formulation. Keywords: Anticonvulsant, Chemometrics, DNA fingerprinting, HPTLC, Pharmacognosy