4^th International Summit on GMP, GCP & Quality Control October 26-28, 2015 Hyderabad, India

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A novel stability indicating liquid chromatographic assay method was developed and validated as per ICH guidelines for the quantitative estimation of afatinib in tablet formulation. An gradient reverse phase LC-method was developed using X-Terra RP-8, 250x4.6 mm, 5 μm column and a mobile phase were aqueous potassium dihydrogen orthophosphate buffer adjusted pH at 3.0 with o-phosphoric acid (mobile phase solvent-A) and acetonitrile:methanol (70:30 v/v) (mobile phase solvent-B) in a gradient mode. The detector set at 258 nm with flow rate of 1.0 mL.min-1. The method is linear between 0.12 to 0.36 mg/mL with a good linear relationship (r2=0.998) was observed and the limit of detection (LOD) is 0.06 μg/mL 0.02% and limit of quantification (LOQ) is 0.06 mg/mL 0.06%. The accuracy of the method was found to be in the range of 99.70% to 100.26%. The mean inter and intraday precision has Relative Standard Deviation (%RSD) were less than 0.147. Robustness was done by change in column, variation in change of flow rate of +/-0.2 mL/min. the values were found to be within the limits. The proposed method was found to be linear, precise and accurate for the quantitative estimation of afatinib in tablet formulations and can be used for commercial purposes.

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The pharmaceutical manufacturer needs to incorporate the technical requirements and all other documents of new pharmaceuticals to market their products in other countries. Any product should reach the criteria of the individual country guidelines. This study mainly discusses ‘’A Brief Analysis of Regulatory Structure and Approval process of Pharmaceuticals in GCC’’. By following the guidance and regulations of GCC,ICH and WHO, filing process of pharmaceuticals in GCC countries will become very easy and accurate. Compilation in eCTD module will be helpful in reviewing of dossier in a very short time In GCC countries will follow the centralized procedure and decentralized procedure to produce approval for the compilation of dossier especially for generics.

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The Latin American pharmaceutical market is among the fastest growing across the world. Latin America market for pharmaceuticals estimates USD 41 Billion and it is assumed to be USD 63 billion by 2013. Although individual markets are growing at different rates, the total market is expected to grow at a compound annual growth rate of more than 10% over the next seven years. Latin America gives special importance to pharmaceuticals industries due to several factors like large pediatric population and low mortality. One of the major drivers of growth for the pharmaceutical markets is the growth of population aged above 65 years, which provide sample opportunities for the growth of drugs treating Alzheimer’s disease, rheumatoid arthritis and osteoarthritis. In addition, the national governments of these Latin American countries have stepped up efforts to increase access to healthcare for its citizens. the Latin American markets, which are already growing at double-digit rates, will receive a huge boost from the increasing use of pharmaceuticals. The economic growth of the Latin American countries is also a key driver in the growth of pharmaceutical markets. However, Latin American countries differ from each other in their regulations, healthcare expenditure and in the composition of the pharmaceutical industry .The present paper discusses about the health and economical conditions in Latin American countries and explore the potential of generic drug market in these countries and their registration process. This also unveils the various challenges which are using hurdle for the generic drug industry in the Latin American countries.

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Every country’s ultimate goal is to protect their people’s health by providing medicines in a qualitative, safe & cost effective manner. Particularly Canada is showing much more attention on their people because of the diseases relevant to their different climatic conditions. Because of low cost, most of the countries are providing generics. It is necessary to apply ANDS (abbreviated new drug submission) to get marketing approval for generics in Canada by considering the guidance, regulations of its regulatory federal authority Health Canada (TPD) Along with ICH guidelines. Everyone should follow CTD to compile generics in Canada. This study is aimed to explain about development, compilation, review & approval of dossiers for generic drugs in Canada and as well as brief information regarding exclusivities. Regulatory executives need to collect all relevant information, documents from manufacturing industries which were authorized by Q.A. department of organization.

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Cleaning validation procedures are carried out in order to assure that residues of cleaning agents are within acceptable limits after the cleaning process. Cleaning agents often consist of a mixture of various surfactants which are in a highly diluted state after the water rinsing procedure has been completed. This makes it difficult to find appropriate analytical methods that are sensitive enough to detect the cleaning agents. In addition, it is advantageous for the analytical methods to be simple to perform and to give results quickly. In this study, four different analytical methods are compared: visual detection of foam, pH, conductivity measurements, and analysis of total organic carbon (TOC). TOC was used as a reference method when evaluating the other three potential methods. The analyses were performed on different dilutions of the cleaning agents Vips Neutral™ , RBS-25™, Debisan™ and Perform™. The results demonstrated that the most sensitive method for analysis of Vips Neutral™, Debisan™ and Perform™ is visual detection of foam, by which it is possible to detect concentrations of cleaning agents down to 10 μg/mL. RBS-25 was not detected below 200 μg/mL, probably because it is formulated with lowfoaming surfactants. TOC analysis is less sensitive but has the advantage of being a quantitative analysis, while visual detection of foam is a semi-quantitative method. Visual detection of foam is easy to perform, gives a quick result, and requires no expensive instrumentation. The sensitivity of each method was found to be dependent upon the type of cleaning agent that was analyzed.

B Poornima is pursuing BPharmacy in Srikrupa Institute of Pharmaceutical Sciences.

cGMP refers to the Current Good Manufacturing Practice regulations enforced by the US Food and Drug Administration (FDA). cGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the cGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories. This formal system of controls at a pharmaceutical company, if adequately put into practice, helps to prevent instances of contamination, mix-ups, deviations, failures, and errors. This assures that drug products meet their quality standards.

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Regulatory audits possibly developed to promote conference with the activation regulations and standards, which collectively prescribed and acceptable level of activation process for obtaining audit evidence and evaluating it objectively to determine the extent to which agreed criteria are fulfilled determine, whether the quality system confirms to specified requirements and effectiveness of the implemented system..Mainly discuss “good practice for the management of quality audit conducted by regulatory audit.”These audits are carried out by regulatory bodies against relevant system for manufacture and supply of pharmaceutical products. National Regulatory bodies such as medicine control agency (MCA) in the UK and FDA in USA Centralized procedure are statutorily responsible for carrying out such audits. They may be unannounced regulatory body from other countries in which products are sold may also audit companies.

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Validation is one of the important steps in achieving and maintaining the quality of the final product. Validation of the individual steps of the process is called process validation. Process validation’s main objective continues to be the generation of a process which yields a product which means meeting its predetermined quality criteria. It is an important component in design, prototyping and manufacturing process and one, if done correctly, that can save a considerable amount of time, money and resource. End product testing by itself does not guarantee the quality of the product. Therefore quality assurance techniques must be used to build the quality into the product at every step and not just tested for at the end. Process validation performs this task to built the quality into the product at every step. FDA had release various guidelines for process validation. This guidelines incorporates principles and approaches that all manufactures can used to validate manufacturing process.FDA considers appropriate elements of process validation for the manufacturing of human and animal drugs, biological products, including active pharmaceutical ingredients. Applicability to manufacturing (including servicing and installation) process for medical devices. Specific recommendation for verification of design output and design validation is included in the GHTF document covering design control. Process validation also emphasizes the role of objective measures and statistical tools and analyses and emphasizes knowledge, detection, and control of variability and gives assurance on consistent of quality/productivity throughout life cycle of product.

Student of Sri indu institute of pharmacy, Ibrahimpatnam ,hyderabad. Pursuing 4 year B.pharmacy with a present aggregate of 80%. Presented a poster at IPC,Hyderabad and RIPE conducted by JNTUH

Good manufaturing practices(GMP) is a part of quality assurance which ensure s that products are consistently produced ,controlled and the standards are made and used according to the required standards by the marketing authorities and then authorised. GMP guidelines hence provide s minimum requirements for pharmaceuticals, food products manufacturing . Maintaining these guidelines assure and certify that products are of high quality and donot cause any risk to the user or the consumer. Playing a biggest role GMP stands up in the first line safety measure in any of the productions.

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The main aim is to compare the stability data of various countries for registration of IND, NDA, and ANDA. Stability plays important role in drug development process. Stability studies ensuring the maintenance of product quality, safety and efficacy throughout the shelf life are considered as prerequisite for the acceptance and approval of any pharmaceutical product. Stability protocols are the mainly required for registration of drug substances and drug products and it contains all the data such as various tests, storage conditions and special tests. Many regions in the world developed their own regulatory stability studies guidelines according to their environmental conditions and their requirements. Most of the stability requirements for WHO, ASEAN, and EMEA are similar to the ICH guideline, except for the parameters like selection of batches and storage conditions. In all the regulatory authorities (USFDA, EMA, ASEAN, LATAM and JAPAN) developed their own guidelines but some countries in those regulatory authorities have different stability data for registration of drug substance and drug product in their particular region. Therefore, Stability tests are carried out so that recommended storage conditions and shelf life can be included on the label to ensure that the medicine is safe and effective throughout its shelf life.

Prachi Bhamre is pursuing her PhD from Pharmacy Department, The Maharaja Sayajirao University of Baroda, Gujarat, India. She has completed three years of PhD and has worked on development of analytical methods including the areas such as QbD and chemometrics.

QbD based DOE approach was explored to study the effect of various factors influencing the optimisation of HPLC method for the simultaneous estimation of the four drugs viz. Ofloxacin (OFX), Ornidazole (ORN), Terbinafine Hydrochloride (TBH) and Clobetasol Propionate (CBP) in bulk drug and cream formulation. A full factorial design was employed to study the factors such as pH of the mobile phase, initial percentage of organic content for gradient elution (%BI) and gradient time (tG). The optimal conditions obtained after applying the principles of QbD with good system suitability parameters for all four drugs were found to be at pH 2.6, %BI as 24% of acetonitrile and gradient time of 4 min. The optimal conditions were found to be in a good agreement with the experimental results. The HPLC method thus developed was validated using ICH guidelines and was applied for the assay of cream formulation. The percentage recoveries were found to be 99.74±0.39 for OFX, 98.72±0.71 for ORN, 98.19±0.23 for TBH and 99.05±0.76 for CBP. The HPLC method was successfully applied to study the in vitro permeability of cream formulation in rat skin using Franz diffusion cell.

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South East Asia region is a developing pharmaceutical market. The regulatory environment has similar characteristics but drug registration requirements and processes differ among the countries. An ASEAN initiative to accord the requirements for drug registration is in progress. Many multi-national research-based pharmaceutical companies have begun to conduct multi-center trials in their global drug development programs involving Asian medical centers for faster patient enlisting to achieve faster drug development. Demonstration of safety and efficacy of the drug product for use in humans is essential before the drug product can be approved for import or manufacturing of new drug by the applicant by regulatory authority in any country. Once preclinical and clinical trial data have been collected, a New Drug Application must be submitted to the regulatory authority for approval. Although In the recent years, there is a steady increase in clinical trial activities in South East Asia. Filing requirements in developed countries differ from developing countries which makes the approval process tedious and time consuming for the later. ACTD a common format have been developed for ASEAN countries for the registration pharmaceuticals for human use for ASEAN Regulatory Authorities.

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For the production of highest and safest quality of dairy food production the industry has to consider the safety controls that aid the processing. These aids include PMO, GMP & HACCP systems. The application of HACCP program in the production of bulk cream and butter production have proven to be a valuable tool for improving the safety and quality characteristics. The effective implementation of HACCP depends on the management commitment, good hygienic practices and personal training programs. Several application of HACCP in dairy products has been already reported. Further more, this review provides the basis for cream and butter HACCP plans, their application throughout the production and distribution chains.

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In this study mainly the comparison between South Africa and ASEAN countries dossier submission were discussed. Dossier is a file document submitted based on requirement of drug approval process. It is a comprehensive scientific document used to obtain worldwide licensing approval of a drug by diverse health authorities. Its creations, processing, compilation & dispatch to the field by a regulatory affairs department, is dependent upon many interrelated activities.The filling process in the emerging markets will be depends upon the region.In South Africa region ZA-CTD filling procedure and in the ASEAN region ACTD filling procedure will be followed. After compilation 1 copy of the dossier will be submitted to the regulatory authorities for the registration of the drug product. Main differences are numbering, granularity andnaming of sections.The ZA-CTD has five Modules with subsections that are numbered. In comparison ACTD consists of Parts I to IV which have subsections A to F. Module 1 of the ZA-CTD is purely country specific whereas Part I of ACTD is administrative data.The summaries of the quality (Part II), non-clinical (Part III) and clinical (Part IV) are located at the beginning of each part of the ACTD. The ZA-CTD dedicates these summaries a separate Module 2. As the ACTD does not have such summary part itconsists only of four. From company to company Quality Assurance procedures may differ, but the goal is to be in compliance with Regulatory guidelines of every country and maintain the Quality of the product.

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The US Food and Drug Administration Office of Generic Drugs has developed a Question-based Review (QbR) for the Chemistry, Manufacturing, and Controls (CMC) evaluation of an Abbreviated New Drug Application (ANDA). This new QbR system incorporates quality by design and implements risk-based assessment. It recommends that ANDAs be submitted using the Common Technical Document and include the Quality Overall Summary (QOS) that addresses all the QbR questions.QbR contains the important scientific and regulatory review questions that focus on critical pharmaceutical attributes for ensuring drug product quality.It contains questions regarding drug substance and 37 questions about the drug product. The study features about Question based Review and corresponding review template for the registration applications. The specificity incorporated into the standardized format of the QbR ensures that critical areas remain the central focus in every review. The main benefits of this QbR system are to (1) assure product quality through design and performance-based specifications, (2) facilitate continuous improvement and reduce CMC supplements through risk assessment, (3) enhance the quality of reviews through standardized review questions, and (4) reduce CMC review time when applicants submit a QOS that addresses the QbR questions. The clear format of the QbR template has provided a framework that has increased review consistency. QbR questions have increased the quality of CMC reviews by shifting the focus of review to areas that are most likely to affect product quality for a particular drug product.

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The aim of present study was to know the role of Quality Assurance (QA) in warehouse activities for ensuring the processes adopted and results produced are meeting the GMP specifications. It ensures that the qualified and trained personnel are employed for doing the activities in the department and addressing, classifying the errors that occurred during the manufacturing operations. Necessary Corrective Actions taken in order to check the errors and control measures taken for the reoccurrence of the same Mistake. In Process Quality Assurance( IPQA) is responsible for affixing hold labels to the damaged packs, ensuring the recording of temperature and RH in storage areas, to identify the documentation errors wherever found out, identification of approved vendors and new vendors, ensuring the status of the materials i.e. Quarantine, approved and rejected, ensuring that the materials stored in appropriate storage areas. Quality assurance giving line clearance for the dispensing of batches and verification of weighing balances calibration and cross contamination of the materials can be prevented by the role of QA. It is concluded that the QA plays a prominent role in every activity in Warehouse and ensures that the results produced meets the GMP specifications.

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Cephalosporins are bactericidal antibiotics that inhibit cell wall synthesis of bacteria. Now, four generations of cephalosporins are available in pharmaceutical dosage forms. UPLC is a new category of analytical separation science that retains the practicality and principles of HPLC, while increasing the overall interlaced attributes of speed, sensitivity and resolution. The resulting chromatograms were recorded and the chromatographic parameters such as capacity factor, asymmetric factor, and resolution and column efficiency were calculated. The condition that gave the best resolution, symmetry and capacity factor was selected for estimation. UPLC improves in three areas such as chromatographic resolution, speed and sensitivity analysis. Smaller particles provide not only increased efficiency, but also the ability to work at increased linear velocity without a loss of efficiency, providing both resolution and speed. Hence, this technique has gained considerable attention in recent days for pharmaceutical analysis.

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A validated specific stability indicating reversed-phase high-performance liquid chromatography method was developed for the quantitative assay determination of Zaltoprofen (ZPF). The analyte peak was well resolved form its process impurities (Imp-1, Imp-2 & Imp-3) and degradent impurities as well. The method was employed on Inertsil ODS-2 column (150 mm x 4.6 mm, 5.0 µm) with a mobile phase consisting of phosphate buffer (pH 3.0) and acetonitrile (45:55, v/v), and detection at 240 nm at a flow rate of 0.8 ml/min. The stress testing of Zaltoprofen was carried out under acidic, alkaline, neutral, oxidation, thermal and photolytic conditions as recommended by International Conference on Harmonization (ICH) guidelines. Significant degradation of ZPF was observed in base degradation. The molecule was found to be stable in all other degradation conditions. The assay of ZPF was unaffected by the presence of its impurities and degradation products and thus confirms the stability indicating power of developed method. The proposed method was validated for specificity, linearity, accuracy and precision. Regression analysis showed correlation coefficient value is greater than 0.999. Accuracy of the method was established based on the recovery obtained between 98.0% and 100% for Zaltoprofen.

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Calypso 4D Localization Systems is a system based on electromagnetic transponders detection enabling precise 3D localisation and continuous tracking of tumour target. This review intended to provide information in order to (1) show how Calypso 4D Localization System works, (2) to present advantages and disadvantages of this system, (3) to gather information from several clinical studies and, finally, (4) to refer Calypso System as a tool in dynamic multileaf collimator studies for target motion compensation. Treatment is done by the implantation of transponders which are excited by an electromagnetic field and resonate back. These frequencies are detected and Calypso software calculates the position of the transponders. If the movement detected is larger than the limits previously defined, irradiation can be stopped. Calypso System has been presented as an accurate tool in prostate radiotherapy treatments. The application of this system to other clinical sites is being developed. The Calypso System allows real-time localization and monitoring of the target, without additional ionising radiation administration. It has been a very useful tool in prostate cancer treatment.

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Engineered carbon nanorods (CNRs) have multiple applications. Present study evaluates cytotoxicity and pulmonary toxicity effects of CNRs (50 - 200nm) using human cell lines and Rat histopathology pulmonary model. CNRs of 1, 3, 10, 100 ug/ml dose were tested on 4 different human cell lines (NCI H-460, Hep 3B, HEK 293 and MCF-7) by MTT method. CNRs were administered at 0.5, 2.5, 5 mg/Kg intratracheally and BAL fluid was collected from particles exposed rats at 24hours, 1week, 4 weeks, and 12 weeks respectively for evaluation of pulmonary biomarkers. The results indicated that CNRs TC50 values 42.46, 42.55, 42.94, 56.78 μg /ml which were less than positive control. The BAL fluid LDH, ALP, Total proteins, MDA values were significant with 0.2mg/kg (p<0.05), 1mg/kg (p<0.01) and 5mg/kg (p<0.001) than control in particle exposed rats. Lung histopathology and gross necropsy study produced a dose dependant pulmonary inflammation, foamy alveolar macrophage accumulation, lymphoplasmocytic infiltration, and fibrosis and diffuse alveolar damage. Finally study concludes that CNRs exerts a dose dependent cytotoxcity on 4 human cell lines significantly at 100ug/ml and Pulmonary toxicity at 5mg/Kg.

Vijayalakshmi Atla was Pursuing her PhD in Andhra University. She was awarded Senior Research fellowship from Council of scientific and Industrial Research (CSIR) India a premier national R&D organization . She has published 4 papers in reputed journals.

Drugs belong to the class like Proton pump inhibitors e.g. Omeprazole (OMP), Pantaprazole (PNP), Lansaprazole(LNP) and Rabeprazole (RBP) are used along with the Prokinetic agents like Levosulpride (LSP), Domperidone (DMP), Itopride (ITP) and Ondansetron (OND) to Improve the Patient compliance in Gastric esophageal reflux disease. They are also used in combination with the NSAIDS like Naproxen (NAP) for the prevention of NSAID induced Gastric ulcers.In the Present study a single Reverse Phase liquid chromatographic method for the separation and quantification of of all the mentioned nine drugs was developed and Validated as per ICH guidelines. The Chromatographic separation of nine drugs was achieved with an Isocratic mobile phase consisting of Phosphate buffer (pH 6.2), Methanol and Acetonitrile in the ratio of 70: 22: 8v/v at a flow rate of 1.2mL min-1 on Kinetix C18 non porous core shell technology column (4.6 ×250mm, 5µm) maintained at 30°C . The eluate was monitored at two different wavelengths i.e 232nm for LSP, NAP and ITP and 285nm for OND, DMP, OMP, RBP, LNP and PNP.The retention time of LSP, ITP, NAP, OND, PNP, OMP, RBP, LNP and DMP was 1.75, 3.35, 4.75, 6.46, 7.97, 9.21, 10.32, 14.94and 19.95 respectively. The Linearity of Calibration curves is good (r2 > 0.999) in the desired concentartion concentration range for all the nine drugs. The method was accurate and precise with recoveries in the range of 98-102% and %RSD < 2%. The proposed method was simple, precise and accurate and hence was successfully applied for the reliable quantification of drugs in commercial formulations.

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A clinical trials registry, is an official platform and for registering a clinical trial. More and more clinical trials are now being recorded in a variety of national and international registries by an increasing number of private and public institutions.ClinicalTrials.gov, run by the United States National Library of Medicine (NLM) was the first online registry for clinical trials and is the largest and most widely used today. Clinical trials are conducted to allow safety and efficacy data to be collected for health. The goal of a clinical trials registry is to provide increased transparency and access to clinical trials, made available to the public. There [World Health Organization] has been a push from governments and international organizations, especially since 2005, to make clinical trial information more widely available and to standardize registries and processes of registering. The ISRCTN is a numerical system for uniquely identifying clinical trials worldwide. ICMJE accepts all primary registries in the WHO network in addition to clinicaltrials.gov. Clinicaltrials.gov is the largest clinical trials registry. The clinical trial registries by countries are as follows: Australia and New Zealand\'s (ANZCTR), Clinical Trials Registry - India (CTRI), EU Clinical Trials Register (EU-CTR), The United States\' ClinicalTrials.gov. Clinical trial registries are also set up and managed by governmental organizations, non-governmental organizations, pharmaceutical companies, and international health organizations. We wonder if clinical trials in our country are being registered in some of these International Registries. If not, would it be time to do so?

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A drug discovery programme initiates because there is a disease or clinical condition without suitable medical products available and it is this unmet clinical need which is the underlying driving motivation for the project. For the purposes of drug discovery , a clinical trial is any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. Clinical trials are used to determine whether new biomedical or behavioural interventions are safe, efficacious and effective. Clinical trials answer 2 questions. • Does the new treatment work in humans? • Is the new treat mint safe? It takes many years for a single drug to come into the market. They perform many tests regarding this tablet. There are both benefits and risks of the clinical trials. It is danger if the drug is not tested properly due to some reasons and is released into the market. For example Thalidomide-This drug is given to the pregnant lady and the baby is born without limbs. This is known after the drug has released into the market. Many children are born without limbs due to these drugs. Clinical trials should be performed very carefully that it will give good result to the person but not affect the person.

Pritpal Singh is Veterinary Microbiologist from College of Veterinary Science, Punjab Agricultural University, Ludhiana and has more than twenty years of experience in supervising as in charge of various veterinary bacterial and viral vaccine production laboratories. He has published more than 20 research papers and attended many national and international conferences regarding vaccines in India as well as abroad. He presented a research paper in international conference “Vaccines Beyond 2000” regarding bacterial veterinary vaccine in 1997 at Australia.

Punjab Veterinary Vaccine Institute, Ludhiana is an integral part of Department of Animal Husbandry, Government of Punjab which was established in 1973 at Ludhiana. The institute has the distinction to supply veterinary vaccines and diagnostic products throughout the state of Punjab as well as other states of India. Considering the regulatory guidelines of WHO and Drug Controller of India, Punjab Veterinary Vaccine Institute is proposed to be upgraded to meet the requirements of GMP. The department decided to establish three wings of Vaccine Institute, (I) Animal House, (II) Bacterial vaccine Production Wing, (III) Quality Control Laboratory, on the lines of GMP requirements for quality vaccines. All maps were developed in respect of shell structure, partitions within the cell structure, keeping in mind classification of clean room, material and manpower movement, temperature, AHU zoning, supply and return air as well as other parameters required to meet GMP norms. As per schedule M, which basically relates to the premises, quality control and production areas are developed independently of each other. Testing of Veterinary Vaccines includes physicochemical, biological and microbiological analysis for which separate laboratories have been established. Quality control is a crucial part of GMP practices that involves taking of samples during the process of vaccine/antigen production. The present map design has been developed keeping in mind the further expansion of production as well as testing of bacterial and viral veterinary vaccines and different diagnostic products.

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The present investigation describes about a simple, economic, selective, accurate, precise reverse phase high performance liquid chromatographic method for the simultaneous estimation of trifluperazine HCl, and isopropramide iodide in pure and in pharmaceutical tablet dosage forms. trifluperazine HCl, and isopropramide iodide were well separated using a Thermohypersil BDS C18 column of dimension 100×4.6, 5 µm and Mobile phase was methanol (75%) and phosphate buffer (25%), where pH was previously adjusted to pH 3.5 consisting of at the flow rate 1 ml/min and the detection was carried out at 222 nm with UV detector. The retention time for trifluperazine HCl, and isopropramide iodide were found to be 1.741 and 3.643, respectively. The developed method was validated for recovery, specificity, precision, accuracy, linearity according to ICH guidelines. The method was successfully applied to trifluperazine HCl, and isopropramide iodide in their combined tablet pharmaceutical dosage forms.