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S. G. Uttarwar*et al. /International Journal Of Pharmacy&Technologyaccepted in official pharmacopoeias or by AOAC International. The validation process minimally includes: standardprecision, linearity, sample precision using replicate samples, sample linearity, selectivity (co-elution, sensitivity toanalyte degradation), retention times, and limits of detection. Other methods which may be of value to the industry maybe included or cited in the monograph but are not required for compliance with the monograph.Who Guidelines for Quality Standardized Herbal FormulationsStandardization and quality control parameters for herbal formulations are based on following fundamental parameters:1. Quality control of crude drugs material, plant preparations and finished products.2. Stability assessment and shelf life.3. Safety assessment; documentation of safety based on experience or toxicological studies.4. Assessment of efficacy by ethno medical information and biological activity evaluations.Quality Control of Crude MaterialAccording to pharmaceutical manufacturers association of U.S. “quality is the sum of all the factors which contributedirectly or indirectly to the safety, effectiveness and acceptability of the product” 4 . Standardization describes allmeasures taken during manufacturing process and quality control leads to reproducible quality of particular product.Standardization of botanicals offers many obstacles because synthetic drugs have well defined structure and otheranalytical parameters as well as reference standard for comparison also established assays and pharmacopoeias.Therefore, quality control is not problematic for synthetic drug 15 . There are several challenges as standardization ofherbal product is considered like controversial identity of various plants, deliberated adulteration of plant material,problems in storage and transport, which should be considered 16 .One of the impediments in the acceptance of the herbalproducts worldwide is the lack of standard quality control profiles. Most of the herbal formulations, especially theclassical formulations of traditional medicine, are polyherbal. In the United States, herbs are used either as dietarysupplements, with minimal standards of safety and efficacy, or as drugs, which require expensive and cumbersometesting procedures.Validation: In order to control quality of herbal drugs in better way, we must amalgamate newer techniques and termsto maximum extent. USFDA defines validation as, “Validation is documented evidence which provides a high degree ofIJPT | July-2013 | Vol. 5 | Issue No.2 | 2509-2519 Page 2516
S. G. Uttarwar*et al. /International Journal Of Pharmacy&Technologyassurance that a specific process will consistently produce a product meeting its predefined specifications and qualityattributes”.Generally, validation investigations must include studies on specificity, linearity, accuracy, precision, range, detection,and quantitative limits, depending on whether the analytical method used is qualitative or quantitative 17 . Also, of utmostimportance is the availability of standards. For macroscopic and microscopic procedures in general this means thatreliable reference samples of the plant must be available. A defined botanical source (e.g. voucher specimens) willnormally solve this problem. This concept of validation is getting well applied to manufacturing of synthetic drugs fromlong time back. But yet not methodically studied and applied for the manufacturing of herbal drugs. Internationalregulations like USFDA, MCC, MHRA, TGA etc. shows the applicability of validation to pharmaceuticalmanufacturing but no one regulation except WHO applies the validation concept to manufacturing of herbal drugs.WHO also emphasize on very little part of validation. Due to aforesaid reason the emphasis on the concept of validationand also the validation model for manufacturing of herbal drugs should be the need of time.Validation Model for Manufacturing of Herbal drugsThere are lots of parameters which has to be considered while certifying the manufacturer the type of herbs as,• Environmental and growing conditions.• Time of harvesting.• Variation in composition.• Drying of herbal drugs.• Packaging of herbal formulations.ConclusionBecause of sobriety of the problem, fundamental knowledge of the important herbs found in India and widely used inAyurvedic formulation along with new standardization techniques is of prime importance and be explored.Incorporation of this will authenticate quality thereby reducing further problems. The development of modern analyticaltools in testing the various quality parameters for an effective quality control herbal product cannot be over emphasized.The assurance of the safety and efficacy of herbal drug requires monitoring of the quality of the product from collectionIJPT | July-2013 | Vol. 5 | Issue No.2 | 2509-2519 Page 2517
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