International Journal of

Pharmaceutical Quality Assurance

ISSN: 0975 9506
Peer Review Journal

doi prefix: 10.25258/ijpqa

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1. Implementation of Quality by Design Approach to the Analytical Method Development and Validation for the Estimation of Rosuvastatin Calcium
Rupali B. Dhamdhere, A. Vijayalakshmi
Quality by Design (QbD) refers to the achievement of certain predictable quality with a predetermined and desired specification. The current studies details QbD enable the development of a simple, rapid, sensitive, and cost-effective high-performance liquid chromatographic method for the estimation of rosuvastatin calcium. The factor screening studies were performed using a 3-factor 12-trials 2-level factorial design. System thematic optimization was performed employing split-plot design by selecting the mobile phase ratio, buffer pH, and column type as the critical method parameter (CMPs) identified from screening studies, thus, evaluating a critical quality attribute (CQA), viz., retention time, peak tailing, and theoretical plate as per the parameter of the method robustness. The optimal chromatographic separation was achieved using acetonitrile and water 75:25 v/v as the mobile phase with a flow rate of 1 mL/min by using a PDA detector at 24 nm. The method was validated as per the ICH recommended conditions, which ensure a high degree of linearity, accuracy, precision, sensitivity, and robustness over the exiting liquid chromatography methods of the drug. Moreover, the lower solvent consumption along with the short analytical run time of 10 minutes leads to a cost-effective and environment-friendly chromatographic procedure. Thus, the proposed method reviled that rapid and represented a good procedure for rosuvastatin calcium.

2. Challenges of HPLC  Method Development and Validation for the Assay of Bemotrizinol from Complex Matrix in Cosmeceutical Preparation
Kallol Jana, Beduin Mahanti
A simple HPLC method was developed for the assay of bemotrizinol (Tinosorb-S) from the complex pharmaceutical cosmetics matrix. Unlike the existing methods, the proposed mobile phase used in this method is very simple and excluding buffer. The use of buffer reducing column longevity and also a time-consuming process which increases the cost of analysis. To overcome all the referred problems, the present article was developed and validated as per ICH guidelines. The reverse-phase chromatography was performed on Shimadzu model no. SPD-M10A VP with LC solution software, µBondapack (3.9 × 300 mm, 10-micron particle size) column with methanol (100%) as mobile phase at a flow rate 2.5 mL per minutes and UV detection at 254 nm. The retention time of bemotrizinol was found in 17.599 minutes, and the linear regression analysis data for the calibration plots showed a good linear relationship in the concentration range 70 to 130 µg/mL. The value of the correlation coefficient, slope, and intercept were 0.996, 7,715, and 15,320, respectively. The limit of quantification (LOQ) and limit of detection (LOD) were found to be 1.32 and 0.44, respectively. The relative standard deviation (RSD) for intra-day sample A 1.0858, sample B 0.8859, and inter-day sample A 0.9921, sample B 0.967 which were found to be lesser than 2%. The developed method was validated with regard to linearity, accuracy, precision, selectivity, and robustness, and the method was found to be simple, cost-effective, precise, accurate, linear, and specific for the successful identification and determination of bemotrizinol in pharmaceutical cosmetic preparation.

3. A Validated specific Stability-Indicating Reversed-Phase High-Performance Liquid Chromatography Assay Method for L-Ornithine L-Aspartate and Silymarin, and their related Substances and its Application to Dissolution Studies
Bhavani Podili, Bajivali Shaik, Prasada Rao Kammela
The present study was aimed at the development and successive validation of a novel, simple, sensitive, and stability-indicating reversed-phase high-performance liquid chromatography (RP-HPLC) method for quantitative calculation of L-ornithine L-aspartate (LOLA) and Silymarin (SL), and also their relevant substances in bulk and pharmaceutical dosage forms. The chromatographic technic was optimized using the impurity-spiked solution. The separation of all the two active components and their impurities was achieved by a chromatographic method with an Agilent Eclipse XDB-C18, 150 × 4.6 mm, 3.5 µ column, using gradient elution with mobile phase A consisting of a mixture of 0.1% orthophosphoric acid and water and acetonitrile as mobile phase B. The instrumental settings included a flow rate of 1 mL/min for both related substances and assay, a detector wavelength of 225 nm, by using a PDA detector. The established method was validated according to the current ICH requirements. The detection limit and the limit of quantification for the two active components and their related impurities were established with respect to test concentration. The calibration graphs plotted were linear with a regression coefficient R2 > 0.999, indicates the linearity of the method was within the limits. Recovery studies were satisfactory and the parameters, such as, specificity, linearity, accuracy, precision, and robustness were determined as part of the method validation. Moreover, using the same method dissolution study was performed on active pharma ingredients to estimate the recovery. The obtained results were within the range of acceptance criteria. These results suggest that the developed method was found to be applicable for routine analysis for testing chromatographic purity of LOLA and SL and it can be utilized for the calculation of both active ingredients and their impurities in tablet dosage forms.

4. Development and Validation of RP-HPLC Method using Photodiode Array or Diode-Array Detection Detector for simultaneous Estimation of the Amlodipine Besylate and Lisinopril in Fixed-Dose Formulation
Aarti Verma, Rupali Sharma, Jaishiv Chauhan, Meenakshi Dahiya, Nitin Sharma
A basic and specific HPLC-PDA (high-performance liquid chromatography-photodiode array) detector showing approach was created for the simultaneous estimation of anti-hypertensive medications—amlodipine besylate (AMD) and lisinopril (LIS). A successful chromatography method was developed using the SunFire C8 column (4.6 × 150 mm, 5 μm) with gradient elution of the mobile phase composed of 85:25 potassium dihydrogen phosphate in water and methanol at a flow rate of 0.7 mL/min. The wavelength was set at 212 nm for the simultaneous estimation of AMD and LIS. The retention time obtained was 5.1 and 10.5 minutes for AMD and LIS, respectively. Descriptive performance of the proposed HPLC methodology was measurably approved as for framework accuracy, linearity, robustness, specificity, precision, and forced degradation for identification and evaluation limits. The linearity range for AMD and LIS correlation coefficient value obtained was R2 > 0.999. The drugs were exposed to forced degradation conditions—acidic, alkali, oxidation, etc. The newly developed reverse phase high performance liquid chromatography (RP-HPLC) method was applied for the detection of the referred to anti-hypertensive medications in
their combination pharmaceutical tablets. Keywords: Amlodipine besylate, Anti-hypertensives, High-performance liquid chromatography, Lisinopril, Photodiode array (PDA).

5. Development and Validation of simple UV Spectrophotometric Method for the Determination of Racecodotril both in Bulk and Marketed Dosage Formulations
Rushikesh D. Ukirde, Ramesh L. Sawant, Ganesh D. Barkade
Racecodotril (RCT), (N-[2-[(acetylthio) methyl]-1- oxo- 3- phenyl propyl] -glycine phenylmethyl ester) is an enkephalinase inhibitor. A rapid, specific, and economic UV spectrophotometric two methods have been developed using a solvent composed of methanol to determine the RCT content in bulk and pharmaceutical dosage formulations. Method A is the absorbance maxima method, in which λmax is 231 nm, linearity was observed in the concentration range 10 to 100 μg/mL for all the two methods, and exhibited good correlation coefficient for method A (r2 = 0.9991) and excellent mean recovery (98.22–102.77%). Method B is the area under curve (AUC), in which λmax 226 to 236 nm was selected for estimation of RCT and exhibited a good correlation coefficient for method B (r2 = 0.9953). The method was validated statistically and by recovery studies for linearity, precision, repeatability, and reproducibility. The obtained results reveal that the method can be employed for the routine analysis of RCT in bulks, as well as, in the commercial formulations.

6. A Review on Pharmaceutical Validation
Kakad S. B., Kolhe M. H., Dukre T. P.
Quality is the primordial intention of any industry and its products manufactured. Multiple views on obtaining such quality are the current interest in the pharmaceutical industry, and it has been maintained by validation. Validation is documented evidence that provides a high degree of assurance. Validation has become one of the pharmaceutical industries’ most recognized subjects. This article provides detailed information about pharmaceutical validation and its importance. Quality is always an imperative prerequisite when we consider the product. In this article, we discuss the types of validation, process validation, equipment validation, cleaning, and analytical method validation. Validation is the process that is used to confirm that the analytical procedure employed for a specific test is suitable for the intended use.

7. Novel Isocratic RP-HPLC Method Development and Validation of ATORVASTATIN Rosuvastatin and Fenofibrate in Tablets
Chandrasekhar Kudupudi, Manikandan A.
A novel simple selective, precise, and accurate RP-HPLC isocratic method was developed for the simultaneous estimation of rosuvastatin and fenofibrate in the combined formulation. The drugs rosuvastatin calcium and fenofibrate were separated in presence of fenofibrate related compound A and fenofibrate related compound B. The drugs and related compounds were separated on Kromasil C18 (250 × 4.6, 5 µ) with a reverse phase isocratic elution. 0.01M potassium dihydrogen phosphate adjusted pH 3.0 with dilute phosphoric acid used as a buffer and acetonitrile used as a solvent in the mobile phase with a ratio of 30:70, respectively. The flow rate was 1 mL/min. 242 nm was the detection wavelength. The retention times were about 3.1 minutes for rosuvastatin calcium, 4.7 minutes for fenofibrate related compound A, 5.6 minutes for fenofibrate related compound B, and 21.6 minutes for fenofibrate. The linearity ranges for rosuvastatin calcium and fenofibrate were 50 to 150 and 800 to 2,400 mcg/mL, respectively, with a correlation coefficient of 0.999 for both. The proposed method validated statistically with respect to system suitability, specificity, linearity, and range, precision, accuracy, robustness, and ruggedness. The method was accurate, linear, precise, specific, selective, and rapid suitable for the quantitative estimation of rosuvastatin and fenofibrate in tablets.

8. Regenerative Medicine: Analysis, Forecast and Regulatory Requirements
M P Venkatesh, A. Akil, Balamuralidhara V, T M Pramod Kumar
Regenerative medicine is a new and expanding field in biomedical research. Organ and tissue loss through disease and injury, propel the development of a treatment that can regenerate tissue and help for less relaying in organ transplantation. Regenerative medicine has the potential to heal tissue and damaged organ. Currently, a patient suffering from diseased and injured organs can be treated with transplantation organs, but there is a shortage of donor organs. Dermatology is estimated to have a larger share in the market for regenerative medicine as skin being an organ with great cell replicate characteristics. US and Japan play a major role in the market for regenerative medicine. Food and drug administration (FDA) regulations for a medical device used in regenerative medicine are covered here to support risk-based, flexible regulatory methods to help and support the potential to bring novel treatment possibilities to market further. But due to incorrect FDA regulations, it stands as a barrier for the marketing regenerative medicines. Better and clear guidance development or a clear regulatory framework for both regenerative medicine and medical device can leads the product a best fit clinical development and product access in the market
Keywords: Regenerative medicine, regeneration, FDA guidance

9. A Review on Analytical Methods of Dapagliflozin: An Update
Shilpi Pathak, Pradeep Mishra
Dapagliflozin is an antidiabetic drug that works on the kidneys of reabsorption of glucose in kidneys by the sodium-glucose co-transporter offer. It is used in patients with type 2 diabetes. It is administered as tablets. It has several analytical papers for estimation of API or drug formulation by RP-HPLC and UV. It is very challenging to use of chemicals, drugs, and solvent of separation methods used in the pharmaceutical product to green chemistry. This review mostly used dihydrogen phosphate buffer and other toxic reagents for estimation and these agents harm instruments, as well as, environment and a lot of waste so that novel analytical techniques for quantifying and defining dapagliflozin should be built as easy as possible and secure for the individual and the community. This review pays attention to the critical condition of physicochemical, properties, action, and aims to focus on different analytical methods for the estimation of dapagliflozin in pharmaceutical formulations.

10. Modification of Choline Derivatives and the Study of their Pharmacological Activity
Alshareeda, Abramovich R. A., Patanina O. G., Alhejoj H
Organic molecules have biological activity for a variety of structural features, some activities are associated with the structural basis of a known molecule, and others are associated with the type and orientation of additive modifications. However, acetylcholine (ACh) is the main neurotransmitter of the parasympathetic nervous system, the part of the autonomic nervous system that contracts smooth muscles, dilates blood vessels, increases body secretion, and slows the heart rate. In the central nervous system, ACh has several rules and it plays an important role in memory and learning, as well as, in the abnormal deficiency of ACh in the brain in people with Alzheimer’s disease. In the past, it has been attempted to use ACh chloride as cholinergic stimulants, but, unfortunately, it has been found that it does not have a lasting effect because of its too short action duration due to its rapid hydrolysis by acetylcholinesterase (AChE) enzymes and the lack of specificity.

11. Carbon Nanotubes as Emerging Nanocarriers in Drug Delivery: An Overview
Vijay Mishra, Manvendra Singh, Pallavi Nayak, Pavani Sriram, Ashish Suttee
Carbon nanotubes (CNTs) have been frequently acquired as one of the fascinating and advanced nanocarriers for drug delivery and many potential applications due to its unique physicochemical properties. During recent years CNTs have been attracted by many researchers as a drug delivery carrier. CNTs are the third allotropic form of carbon-fullerenes rolled into cylindrical tubes. To be integrated into the biological systems, CNTs can be chemically modified or functionalized with therapeutically active molecules by forming stable covalent bonds or supramolecular assemblies based on noncovalent interactions. Owing to their high carrying capacity, biocompatibility, and specificity to cells, various cancer cells have been explored with CNTs for evaluation of pharmacokinetic parameters, cell viability, cytotoxicity, and drug delivery in tumor cells.

12. Impact of Ocimum Tenuiflorum Mediated Green Synthesis of Silver Nanoparticles on In vitro Antioxidant and Antibacterial Activities
Anto Cordelia T. A. Dhanapal, Ashwinie N. Warrant
The leaf extract of Ocimum tenuiflorum was used to synthesize silver nanoparticles (AgNPs), and evaluated for its antioxidant and antibacterial properties. The silver nanoparticle was characterized using the UV-vis spectrophotometer, SEM, fourier-transform infrared spectroscopy (FTIR), and X-ray diffraction (XRD). The total phenolic and total flavonoid contents were determined for both leaf extract and synthesized silver nanoparticles. Antioxidant activities before and after synthesis of silver nanoparticles was assessed by 2-diphenyl-1-picrylhydrazyl (DPPH), 2’-azino-bis(3-ethylbenzothiazoline-6-sulfonic acid) (ABTS), iron chelating, and Nitric oxide (NO) radical scavenging methods. The antibacterial, activity of the leaf extract and AgNP were tested against Escherichia coli and Staphylococcus aureus. Statistical analysis was carried out to establish possible relations between the antioxidant, antibacterial and antioxidant activities. The formation of a dark brown solution mixture confirms the formation of silver nanoparticles at a wavelength of 450 nm. The AgNPs synthesized were spherical, with the size between 14 to 33 nm. Functional groups, such as, alcohol, aldehyde, nitrile, primary amines, carbonyl, and aromatic groups were confirmed by FTIR and XRD. Total phenol was higher in leaf extract, while total flavonoids were higher in the AgNPs. Silver nanoparticles exhibited strong NO scavenging activity while leaf extract showed better ABTS scavenging activity. Silver nanoparticles inhibited E. coli better compared to S. aureus bacteria. It can be coined that the leaf extract of O. tenuiflorum mediated the green synthesis of silver nanoparticles and possess strong antioxidant and antibacterial potentials that can find application in various biomedical areas.

13. Niosomes: Potential Nanocarriers for Drug Delivery
Vijay Mishra, Pallavi Nayak, Manvendra Singh, Pavani Sriram, Ashish Suttee
Niosomes are novel vesicular drug delivery systems, where the solution is surrounded by non-ionic surfactant vesicles. The niosomes offer different benefits over the traditional drug delivery system. Niosomes are structurally similar to liposomes, as they also consist of a bilayer. In the case of niosomes, the bilayer consists of non-ionic surface-active agents instead of phospholipids, as seen in liposomes. Niosomes are much more stable during the process of formulation and storage as compared to liposomes. Niosomes may resolve the issues of insolubility, volatility, poor bioavailability, and rapid drug degradation. It has been discovered in recent years that, these vesicles can enhance drug bioavailability and can act as a new strategy to deliver many conventional therapeutic agents such as protein drugs, and gene materials. It is also easy to prepare and scale up this novel delivery system with low production costs. The delivery of drugs via niosomal formulations may be relevant to several pharmacological agents for their activity against different diseases. The present review provides an overview about the advantages and disadvantages, fabrication techniques, types, characterization technique, and different applications of niosomes.

14. Antimicrobial Effectiveness of Silver Nanoparticles enriched Tea Leaves
Saravanan Krishnan, Deepak Srisrimal, Abhaya Kumar Srisrimal
Silver nanoparticles (NL SILVER) are well recognized for their antimicrobial properties for many years. In the present study, NL SILVER synthesized by a green method is investigated for its anti-microbial efficacy, when added in tea leaves. Further, the potential role of NL SILVER in controlling the growth of foodborne pathogens was evaluated. Results indicate that NL SILVER present in the tea liquor contributes about 50% higher anti-bacterial activity against the foodborne pathogens tested when compared with the untreated tea sample. A significant observation is that the microbial load in the tea reduced due to the presence of NL SILVER. Collectively, this study indicates the importance of NL SILVER as an anti-microbial agent in controlling the microbial growth associated with food spoilage. In addition, it is likely to enhance the quality and shelf life of tea.

15. Formulation and Taste Masking of Metronidazole Oral Disintegrating Tablets by a Novel Approach
Pavani Sriram, Ashish Suttee, Marasakatla Z
The anti-protozoal drug, metronidazole, is developed as an oral disintegrating tablet (ODT) to treat amoebiasis and to bypass hepatic metabolism. The work aimed to prepare, taste-masking oral disintegrating tablets of metronidazole using different proportions of the drug and disintegrants in various ratios by an effervescent method. The ODT was developed by direct compression with various concentrations of super disintegrating agents (1-7%). In this technique, sodium bicarbonate and tartaric acid were used to generate effervescence. The formulated tablets were assessed for physicochemical characteristics. The results of FTIR spectroscopy indicated the stable character of metronidazole. In vitro studies revealed that batch F6 was having a 97.65% cumulative amount of drug release at 20th minute compared to other formulations. Due to the effervescent method, there was a significant increase in drug release, seen at the 1:1.5 ratio. Taste evaluation studies were conducted on healthy human volunteers.

16. Synthesis of Glibenclamide-Oxalic Acid Cocrystal using Thermal Solvent-Free Method
Arif Budiman, Sandra Megantara, Rifaa’tush Sholihah, Saeful Amin
Solubility is an important parameter affecting the bioavailability of drugs. The solubility of an active pharmaceutical ingredient (API) could be improved through the formation of cocrystal, which is a crystalline complex composed of two or more different molecules. Glibenclamide (GCM) is an API with poor solubility in water, which belongs to class II, characterized as highly permeable with low solubility. Therefore, this study aimed to synthesize and characterize the cocrystal of GCM-oxalic acid (OA) using the melting method. The interaction between GCM-OA complexes was predicted using the in silico method. Also, the cocrystal complexes were characterized by differential scanning calorimetry (DSC), infrared (IR) spectrophotometry, and powder X-ray diffraction (PXRD), as well as, through solubility and dissolution tests. The result showed that GCM and OA have the potential of forming cocrystal through the in silico method. Also, the cocrystal of GCM-OA with a molar ratio 1:2, significantly improved the solubility and dissolution profile of GCM. In addition, the spectrum IR of cocrystal exhibited a shifting peak at 1,700 cm-1 indicating the presence of intermolecular interaction between GCM and OA. Furthermore, the DSC and PXRD analyses showed a new single endothermic peak and new diffraction peak pattern, respectively, indicating the formation of a new crystalline component.

17. Comparative Hypoglycaemic Activity of Fixed Dose Combination Anti-Diabetic Formulations vs. Respective Monotherapies in Diabetic Rabbits
Rajarao Chinta, Rohini P
Type 2 diabetes mellitus is a disease of impaired glucose homeostasis and chronic hyperglycemia. Current approaches for the treatment frequently involving the use of combination therapy. The aim of the present study was to evaluate and compare the hypoglycaemic activity of fixed-dose combination anti-diabetic formulations and respective individual agents using rabbits as an animal model. Experimental diabetes was induced by a single intravenous injection of alloxan monohydrate at a dose of 150 mg/kg. Individual drugs and combination tablets were administered to experimental groups. Fasting blood glucose level was estimated at 0, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours using glucometer. Data were statistically analyzed using student t-test and p<0.05 considered as statistically significant. The reduction in fasting blood glucose level in diabetes-induced rabbits was significantly higher with combination products compared to individual drugs. Fixed-dose combination products had shown improved glycaemic control than individual agents. Fixed-dose combination therapy can be used as a suitable option for selected patients requiring multiple glucose-lowering therapies for use as an adjunct to diet and exercise to improve glycaemic control in type 2 diabetes mellitus.

18. Formulation and Evaluation of Levocetirizine Dihydrochloride and Ambroxol Hydrochloride Lozenges
Sriram P, Arsham P, Thout Reddy R, Suttee A
The present work aims to formulate and evaluate levocetirizine dihydrochloride and ambroxol hydrochloride hard candy lozenges to produce a slow-release of drugs for the management of cold and cough. The lozenges were prepared using sucrose, liquid glucose, hydroxyethylcellulose, and hydroxypropyl methylcellulose K4M by heating and congealing method. Sweetener with flavors was utilized to facade the bitter taste of the drug. The developed lozenges were exposed to various physical and chemical characters, in vitro disintegration and dissolution. The developed formulations include hardness of 8–11 kg/cm², non-gritty, and agreeable mouthfeel. The optimized formula was examined for drug excipient interactions subjecting to Fourier transform infrared (FTIR) spectral analysis. Drug release for lozenges was highest in formulation FL8. The hard candy lozenges can present an attractive substitute formulation in allergic conditions.

19. A Simple Reverse Phase UPLC Validated Method for Concurrent Estimation of Daunorubicin and Cytarabine in Drug Substances and Drug Product
Suresh Gandi, A. Manikandan, S. Venkat Rao
A fast, precise, accurate, and steadiness indicating isocratic liquid chromatographic technique was created for the synchronous assurance of the daunorubicin and cytarabine in bulk and formulation. To optimize a column CHS C18 100 × 2.1 mm, 1.8 µm, mobile phase, including buffer 0.1% orthophosphoric acid, acetonitrile pick in the proportion 70:30 v/v, was pumped through the column at a flow rate of 0.3 mL/min at 240 nm, initiate to be an efficient method for elution of drug with good peak shapes, as well as, retention times. The retention time of daunorubicin and cytarabine were initiated to be 0.556 and 0.743 minutes. The % recovery was got at 100.07 and 99.88% for daunorubicin and cytarabine separately. The limit of detection (LOD) and limit of quantitation (LOQ) values got from the relapse formula of daunorubicin and cytarabine were 0.16, 0.5, and 0.64, 1.93, correspondingly. The relapse equation of daunorubicin is y = 2974.3x + 648.32, and y = 4896.5x + 4851.5 of cytarabine.

20. Study the Effect of Vitamins (C and E) on Oxidative Stress and Antioxidants Changes Induced by VCM in Male Rats
Shaymaa J. Shamran, Haider S. Jaffat
The current study was designed to determine the antioxidant effects of Vitamin C and Vitamin E against oxidative stress induced by vancomycin (VCM) in some antioxidants changes in the male rats. The study was conducted in the animal house of the Faculty of Science, University of Kufa for the period from April to May/ 2018 on 119 animals of male rats aged 2.5 to 3 months and the weight of 150-200 grams. Two experiments designed in this study addressed the oxidative effect of VCM in addition to the protective effects of vitamin C and vitamin E to reduce these effects in the treatment of animals for one week and three weeks with VCM and VCM plus vitamins. The results indicated a significant increase (p < 0.05) in the mimimal disease activity (MDA), computerized axial tomography (CAT), and significant decrease (p < 0.05) in superoxide dismutase (SOD), and glutathione peroxidase (GPX). In the animals treated with VCM 40,60 mg/kg only compared to the control group for the two periods of administration at the same time occur a significant decrease (p < 0.05) in the MDA, CAT, and a significant increase (p < 0.05) in the SOD and GPX after treated animals with VCM 40, 60 mg/kg with vitamin C and vitamin E for a period of one and three weeks compared with VCM group.

21. Vigilance System Requirements Across US and EU for Medical Device
Shashank N, M P. Venkatesh, Yamini Krishna, T.M. Pramod Kumar 
Medical device vigilance is concerned about device problems (incidents) their analysis and mitigation to ensure that device performance is good and that patient safety are maintained. The main aim of this is to outline the criteria of the medical device vigilance program and to highlight the requirements that still remain in the state laws of regulated markets (US & EU) and to increase access to safe, reliable and therapeutic benefits. The severity of the Subject, risk assessment should carried out by the manufacturer prior to marketing. In US, Medical Device surveillance deals with post-marketing monitoring where the manufacturer or importer is required submit reports to regulatory authorities; same as in the EU. US medical device tracking system involved with different sections to update adverse event. The user or manufacturer has to report incidents to member states where necessary actions are to be taken as early as possible to protect or reduce hazard of casualty or severe decline in terms of safety and quality by implementing the CAPA for risk analysis.
Keywords: Vigilance, FSCA, PMS, Medical device, FTA, US, EU.

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