The rate of breast cancer is rapidly increasing and discovering medications with therapeutic effects play a significant role in women's health. Drugs derived from marine sponges have recently received FDA approval for the treatment of malignant tumors, including metastatic breast cancer. Spirastrella pachyspira (marine sponge) is mainly obtained from the western coastal region of India, and its anticancer potential has not been explored. Hence, the present study aimed to evaluate the anticancer potential of Spirastrella pachyspira extracts and its bioactive molecule sphingosine. The extracts were prepared using hexane, chloroform, ethyl acetate, and ethanol. The cytotoxic potential of the extracts were determined by an in-vitro MTT assay using SK-BR-3 cancer cell line. Subsequently, acute toxicity investigation was conducted in Swiss Frontiers in Marine Science frontiersin.org 01

Vendor evaluation, a part of the cGMP which is used to ensure the procured products from the vendors,are meeting their quality standards. To avoid the procurement of substandard products from vendors, it is necessary to qualify the vendor / supplier which can avoid the adverse effect on the quality standards, regulatory requirements, and safety of the patients. The main objective of this review paper is to provide an overall outline of the vendor evaluation and to avoid quality failure and promote patient safety. This review paper covers the methods and criteria for evaluating of vendors in the pharmaceutical industry. This paper focuses on vendor evaluation by questionnaire to meet current Good Manufacturing Practice (cGMP). This text reviews the practical challenges faced and strategic plans of the pharmaceutical industry to achieve compliance management and the quality standards of products. An overview of the methods and approaches followed by the pharmaceutical industry to meet the regulatory requirements which were proposed by the leading regulatory bodies like the US Food and Drug Administration (USFDA) and European Medicines Agency (EMA) is briefly described. Most of the studies focus on criteria and methods, but rarely on approaches and questionnaires. Study includes the approaches, methods, criteria and questionnaire to achieve the quality and regulatory compliance and also emphasizes the vendor to stay confident on quality and the compliance of their products produced. The key points on the vendor questionnaire were effectively discussed, which remains the most common and effective method of vendor evaluation. This review paper also helps the professionals to arrive at an overall outline about the vendor evaluation aspects and questionnaire. The outcome of the study shows the importance of vendor evaluation, which helps in supply chain management. , , , .

Change control is a basic element of the quality management system of a pharmaceutical company, that focuses on controlling change to provide a quality product by preventing non - compliance. Changes may occur at any time during the product life cycle, leading to changes in the manufacturing process, the number of materials, and the manufacturing location. All of these changes are post-approved changes. These changes can be controlled and not eliminated, through proper assessment and action plans. The change control committee consisting of the head of quality assurance, manufacturing, sales and other members of relevant disciplines, inspect the proposed changes that may alter the validated and qualified state of facilities, equipment or process. The proposed change will likely have an impact on the quality of production or Good Manufacturing Practice as there are done to be in line with the International Standard Organization requirements. These approved changes should not impact the quality, safety and potency of medicinal product. If ignored, it makes the patient life - critical which may even lead to death. This present review provides an overview of the industry’s Change Control change management protocol in Quality Management System in a company. The major objective is to identify, evaluate, measure, provide action and final authorization to ensure that the changes should not affect the product strength, integrity, purity, quality, or safety. There are many aspects of view on the change control management that take place in the pharmaceutical industry, where we can gain knowledge on concepts of change control. This article also delivers a flow of change management process starting from the request on change by an initiator to the closure of change with appropriate remedial action and follow up assigned by Quality Unit and other responsible authorities.

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This study aimed to assess the perception and the preferences of undergraduate pharmacy students towards traditional classroom-based versus online teaching-learning and assessment during the COVID-19 pandemic. A standardized questionnaire was developed, statistically validated and administered to a total of 531 students pursuing Pharm. D or B. Pharm in the Pharmacy college of a deemed university through mail and WhatsApp as google forms. The completed responses obtained from 454 students were analyzed for their preferences and perceptions towards both methods of teaching-learning and assessments. The significant differences in the responses between students of both programs were assessed using unpaired sample t-test. There were 288 (64%) responses from B. Pharm and 166 (36%) from Pharm. D students. The difference in year of study (i.e. duration of the program), age and number of courses between the two programs were highly significant. Majority of the students stated classroom-based teaching as more advantageous (42.6%). Easy access to the teaching material (51.4%) and lack of personal contact with the teacher (40.2%) were considered as major advantage and disadvantage to online teaching-learning respectively. 54.1% of students opted for online and 46.9% chose traditional classroom teaching for interest generation towards learning. Majority of the students in both programs (43% and 53% respectively) preferred both classroom-based and online teaching-learning to enhance their knowledge, skills and self-directed learning. Similarly, the preferences for assessments were higher for conventional mode of in-person written examinations (71.2%) and remote online assessments (29.8%) through multiple choice questions, assignments etc. Thus students’ perception towards an in depth understanding of the concepts was in favour of traditional classroom based teaching learning, whereas interest towards learning and accessibility to study materials were in favour of online teaching learning. Most of the students preferred learning through blended mode rather than being exposed to either one of the teaching-learning techniques. However, there was a higher preference for conventional in-person mode than the online mode of assessments. Academic dishonesty, technological inconsistency and incompetency were identified as major bottlenecks for remote online assessments.