phd topics in pharmaceutical quality assurance

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Bulletin 2023-2024, pharmaceutical sciences/regulatory affairs and quality assurance phd.

SCHOOL OF PHARMACY

Learn more about the Doctor of Philosophy in Pharmaceutical Sciences .

About the Program

The School of Pharmacy offers a graduate program leading to the PhD in Pharmaceutical Sciences with a concentration in Regulatory Affairs and Quality Assurance (RAQA). Emphasis is placed on combining scientific principles and methodology with regulatory and quality practices to streamline the discovery, manufacturing, safety profiling and post-approval processes. The program applies academic research methods to current industry regulatory issues, enabling candidates to pursue a dissertation that helps to define and resolve regulatory or quality problems with data research and scientific methodology. The goal of each dissertation is to present new and thoughtful answers to industry questions and problems that result in cost savings, safer and/or more effective products, better safety profiles, and other benefits for patients and manufacturers.

The RAQA concentration is designed for professionals who have a minimum of 15 years of relevant work experience, including supervisory responsibilities, in pharmaceutical and related sciences and/or regulation in such areas as analytical methods, clinical and pharmacovigilance supervision, corporate drug development or manufacturing science, quality practices, validation implementation, and other pertinent industry practices that draw heavily on regulatory policy and quality assurance. Work experience must be applicable to the topic candidates plan to investigate for their dissertation.

Selection is highly competitive as a very limited number of candidates is accepted each year. Successful candidates are expected to have:

• a master’s degree or the equivalent in a pharmaceutical, science, medical, engineering or related field;
• a minimum of 15 years of work experience in the field related to their PhD dissertation;
• current work experience that can be applied to the regulatory/quality topic to be investigated for their PhD dissertation;
• the ability to work both independently and as part of a team, displaying recognizable initiative;
• a willingness to pursue original, independent research, utilizing a multidisciplinary approach to problem solving;
• strong communication skills, both verbal and written, including the ability to write academic research papers containing original thought and cogent arguments;
• basic knowledge of data analysis, having completed at least one course in statistical methods; and
• the ability to accept constructive criticism and welcome feedback provided by the Dissertation Advisor and Dissertation Advisory Committee.

Time Limit for Degree Completion:  7 years

Campus Location:  Health Sciences Center, Fort Washington

Courses may also be offered at Main campus. Research must be carried out, however, at the Health Sciences Center campus under the supervision of an advisor who is a member of the Graduate Faculty.

Full-Time/Part-Time Status: The degree is completed on a part-time basis in 2 to 5 years. Successful candidates are expected to pursue the PhD program at least two terms every academic year (Fall, Spring or Summer) until the dissertation is completed. Typically, students pursue the PhD every Fall and Spring term, but a Summer term may be substituted. Note that a minimum of one credit each Fall and Spring term is required to maintain the candidate’s active student status.

Job Prospects: Job opportunities include positions as postdoctoral researchers, scientists in the pharmaceutical industry, and faculty members.

Non-Matriculated Student Policy:  Non-matriculated students are ineligible for participation in the program.

Admission Requirements and Deadlines

Application Deadline:

Fall: March 1

All applications are evaluated together after the deadline. Selection is highly competitive. A very limited number of candidates is accepted each year.

APPLY to this graduate program , submitting the application to [email protected] .

Letters of Reference: Number Required:  3

From Whom:  Letters of recommendation should be obtained from college/university faculty members familiar with the applicant's academic competence and/or professionals in a supervisory position.

Master's Degree in Discipline/Related Discipline:  A master's degree or equivalent is required in a pharmaceutical, science, medical, engineering or related field. Course credits achieved in the master's degree may be applied toward the PhD program's credit requirements. 

Bachelor's Degree in Discipline/Related Discipline:  A baccalaureate degree is required.

Transcripts from all post-secondary institutions attended may be sent electronically to [email protected] . Alternately, unopened official transcripts bearing the school’s seal must be sent directly from the Registrar at each institution to the Regulatory Affairs and Quality Assurance Graduate Program .

Applicants who earned a degree at a non-U.S. institution must submit an equivalency evaluation of their transcript(s) through a third-party provider, either  World Education Services (WES)  or  Educational Credential Evaluators (ECE) .

Statement of Goals:  In approximately 500 to 1,000 words, state your specific interest in Temple's program, research goals, future career goals, and academic and research achievements.

Standardized Test Scores: Applicants who earned their baccalaureate degree from an institution where the language of instruction was other than English, with the exception of those who subsequently earned a master’s degree at a U.S. institution, must report scores for a standardized test of English that meet these minimums:

• TOEFL iBT: 85
• IELTS Academic: 6.5
• PTE Academic: 58

Resume:  Current resume or CV required.

Other Requirement: It is recommended that applicants provide a commitment statement from their employer indicating that the employer supports the individual’s involvement in the RAQA PhD program.

Program Requirements

General Program Requirements: Number of Credits Required Beyond the Baccalaureate: 40

Required Courses:

The School of Pharmacy accepts up to 30 credits. The decision of the School on the number of credits accepted is final.

A minimum of one 3-credit graduate-level course is to be completed. This coursework is related to decision analysis, quantitative methods, research design, scientific decision-making, statistics and probability for data analysis, and the like.

The number of credits accepted toward the PhD and the number required for completion of the PhD are determined by the Dissertation Advisor and the Graduate Committee of the School of Pharmacy. It may be determined that additional coursework is required to prepare the student to write the dissertation. The course grid below lists approved course options.

Additional Approved Coursework Options 1

Other coursework in Regulatory Affairs and Quality Assurance may also be assigned by the Dissertation Advisor.

QARA 5478 High Purity Water Systems is a third choice.

PS 5501 Development of Sterile Products is another option.

QARA 5505 Global Regulation of Medical Devices is also approved.

QARA 5591 Global Regulatory Affairs can also be selected.

  QARA 5650 may only be taken with departmental approval.

Other Requirement: Formal evaluation of each PhD student’s progress occurs at the end of the first year and each year thereafter to ensure that the quality of work will result in a fully approved dissertation project. Failure to conduct a reasonable amount of research or writing could result in suspension or dismissal from the program. The following is a typical dissertation schedule:

• Assess dissertation proposal topic, including candidate’s knowledge span to determine strengths and deficiencies.
• Determine additional coursework required, if any.
• Review candidate’s past work and publications as they pertain to the PhD dissertation.
• Select final dissertation topic and possible research protocol.
• Outline dissertation proposal, research protocol and introductory chapter by Year 1's end.
• Meet with research advisor as required and recommended.
• Pursue research activities to depict quantitative, qualitative and policy analysis methods, including literature review and annotated bibliography.
• Prepare dissertation introduction, discussion and conclusion.

Final Year:

• Prepare dissertation material for one or more publications.
• Defend dissertation as required by the School of Pharmacy.

Culminating Events: Dissertation Proposal: The dissertation proposal demonstrates the student's knowledge of and ability to conduct the proposed research. The proposal should consist of:

• the context and background surrounding a particular research problem;
• an exhaustive survey and review of literature related to the problem; and
• a detailed methodological plan for investigating the problem.

Upon approval of the dissertation proposal, the doctoral student is promoted to PhD candidacy, and a timeline for completing the investigation and writing process is established.

Dissertation: The doctoral dissertation is an original, theoretical and/or empirical study that makes a significant contribution to the field. It should expand existing knowledge and demonstrate the student's knowledge of research methods and a mastery of their primary area of interest. The dissertation should be rigorously investigated; uphold the ethics and standards of the field; demonstrate an understanding of the relationship between the primary area of interest and the broader field; and be prepared for publication in a professional journal. It is expected that the dissertation will consist of an appropriate mix of quantitative and qualitative research methodology and be suitable for publication.

The Dissertation Examining Committee (DEC) is formed to oversee the student's doctoral research. It is charged with evaluating the student's dissertation and oral defense, including the student's ability to express verbally their research question, methodological approach, primary findings and implications. The DEC, which includes the members of the DAC, is comprised of at least three Graduate Faculty members. Two members, including the Chair, must be from the School of Pharmacy. The Chair is responsible for overseeing and guiding the student's progress, coordinating the responses of the Committee members, and informing the student of their academic progress. At least one additional Graduate Faculty member from outside the School of Pharmacy must be included on the DEC. This outside examiner should be identified no later than the beginning of the academic term in which the student will defend the dissertation. The DEC members vote to pass or fail the dissertation and the defense at the conclusion of the public presentation.

Committee compositions must be approved by the departmental graduate committee. If a student needs to change a member of a committee, the new member must be approved by the departmental graduate committee and by the Graduate School. The changes must be documented with the Administrative Assistant and the Graduate School using the "Request for Change in Dissertation Committee" form, found in TUportal under the Tools tab within "University Forms."

Students who are preparing to defend their dissertation should confirm a time and date with their DEC and register with the Office of Graduate Studies at least 15 days before the defense is to be scheduled. The Office of Graduate Studies arranges the time, date and room and forwards to the student the appropriate forms. After the Administrative Assistant has made the arrangements, the student must send the Graduate School a completed "Announcement of Dissertation Defense" form, found in TUportal under the Tools tab within "University Forms," at least 10 days before the defense date. The department posts announcements for the defense.

Program Web Address:

https://pharmacy.temple.edu/academics/phdms-pharmaceutical-sciences

Department Information:

Dept. of Pharmaceutical Sciences Office of Graduate Studies

School of Pharmacy

3307 N. Broad Street, Suite 528

Philadelphia, PA 19140

[email protected]

215-707-4972

Submission Address for Application:

[email protected]

Mailing Address for Application Materials:

Temple University

Regulatory Affairs and Quality Assurance Graduate Program

425 Commerce Drive, Suite 175

Fort Washington, PA 19034-2728

Department Contacts:

Admissions:

RAQA Academic Coordinator:

Peter H. Doukas, PhD

Graduate Chairperson:

Swati Nagar, PhD

[email protected]

Department Chairperson:

Ellen Walker, PhD

[email protected]

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Doctorate in Regulatory Science

• DRSc Admissions
• Course Schedules
• Curriculum and Requirements
• Doctoral Dissertations
• Doctoral Program Cohorts
• Frequently Asked Questions
• On-Site / Distance Program
• Scholarships

The USC Doctorate in Regulatory Science (DRSc) program is the only doctoral program in regulatory science in the world. The program of study is designed to cultivate research, leadership and inquiry skills for advanced students in the emerging profession of global regulatory science. It is designed to produce graduates who have a particular expertise in strategic management, policy development and research assessment and who will work in senior positions in the public sector, academia and the medical products industry.

Participants in this program take a set of interdependent courses that extend from a strong core of basic regulatory science coursework and additionally focus on three main areas—global product strategy, product lifecycle strategy, and project and personnel management.

The program is designed to meet the needs of individuals who are already working full-time outside of the university in positions in which they have substantial leadership or managerial responsibilities. A typical student in the program has somewhere between 10 and 15 years of experience in the regulated product industry with several years of experience managing or directing regulatory or quality departments.

What is the difference between a DRSc and PhD in Regulatory Science?

The DRSc is classified as a professional doctoral degree. USC does not offer a PhD in regulatory science.  However similar to the PhD, the DRSc includes a research-based dissertation and bestows the title of “Doctor” on its recipients. The key difference between the degrees is that the research for the PhD is more “lab-based” and most students who receive the PhD are interested in an academic career path of teaching and research. The benefit of the DRSc is the potential of our graduates to work in both professional (government, industry) and scholarly/academic capacities.

Why a Doctorate in Regulatory Science?

Foods, drugs and medical devices have been regulated for more than a century. In the last decade, however, we have seen dramatic change in the level of preparation needed for effective management in this sector. Societal concerns over safety, globalization and technological innovation have increased the amount and detail of administrative law in the U.S. and other areas of the world. At the same time, the increased sophistication of medical products has driven out the generalist; now regulatory leadership depends on a constellation of skill sets in science, law and management. Individuals who will lead the regulatory teams of the future must possess critical thinking skills and research acumen to be able to evaluate their own product and position it in a crowded marketplace. At the same time, they must possess a strong knowledge of policy and law, and must be able to work with large and diverse teams of individuals with different specializations and work cultures.

In a recent market survey in which industries were asked what were the skill sets that need to be developed in regulatory leaders, attention was drawn to three types of capabilities: outstanding people and project management skills, a good capability to understand and work within transnational organizations to make globally relevant decisions, and a broader knowledge of policy and business than is typically acquired at junior and mid-levels of the regulatory career structure. A further pressing problem is the graying of the current high-level regulatory professional. Most of the current leadership in regulatory science comes from individuals on the verge of retirement. These individuals learned on-the-job slowly as the regulations developed and now are leaving the field; the next generation of leaders will not have the same luxury.

Up to the present, a number of master’s programs in regulatory science have been developed, but these are designed to educate practitioners in early career stages. What is needed now is a more advanced program that generates leaders equipped with tools and knowledge appropriate to individuals in the upper echelons of the profession where they command many subordinates and take responsibility for decisions that steer policy or company strategies. We are responding to the needs of industries who are interested in recruiting and further training regulatory talent and from the professional organizations with a strong need for strategic and research training to support policy and business decision-making. Our goal is to develop individuals who can serve as leaders. However, in this case, those leaders are needed as a part of the health care system, where they will oversee the development and commercialization of medical devices, pharmaceuticals and foods, and will lead companies and government agencies concerned with regulatory planning and policy. These are the individuals who will replace the previous generation of regulatory experts, but they must be broader than most current experts. The products that they will foster, and the culturally and economically diverse countries in which they must operate, present a paradigm shift of a kind that this industry has not seen before. If we are to assure that new technologically sophisticated products make it to the marketplace, we must find new ways of benchmarking best practices and shortening the critical path that now exceeds a decade for most innovative pharmaceuticals and devices. Our vision is coherent with that of the NIH and FDA whose Roadmap Initiative and Critical Path activities stem from strong concern about the ability to sustain growth in this sector using old methods.

What has been your favorite part of the regulatory science program?

“I enjoy meeting the unique individuals in the program; it is a wonderful way to network within the industry. Before the COVID-19 pandemic, the program allowed students to travel to Europe and Asia to meet regulators who would educate us on global aspects in regulatory science, which helped me adopt a different perspective beyond the United States.”

Cheryl Hergert

Doctor of regulatory science ’22, mph, gdpr clinical trial compliance director, exelixis.

How did you come to the decision to pursue your degree at USC?

“I had been researching the DRSc program for quite some time. This program is the only doctoral program of its kind in the world, and it gave me the flexibility to work while going to school. The opportunities to travel abroad to the Asia Pacific (APAC) and Europe, Middle-East and Africa (EMEA) were also attractive. Looking at the big picture, USC is a world-renowned university so I knew that I would get a quality education here and improve my skill set as a practitioner.”

Lequina Myles

Doctor of regulatory science ’21, ms regulatory science, senior director, quality assurance and regulatory affairs at phenomenex.

Modern Aspects of Pharmaceutical Quality Assurance pp 1–7 Cite as

Introduction: Quality Assurance from Perspective of Pharmaceutical Industry

• Minal Ghante 4 ,
• Shrikant Dargude 4 ,
• Arpana Patil 5 &
• Vidhya Bhusari 4  
• First Online: 12 March 2024

38 Accesses

Pharmaceutical development requires product quality, design, and operational efficiency. Pharmaceutical development is a multifarious process that encompasses various facets, including product quality, design, and operational efficiency. Operational excellence helps improve pharmaceutical product quality by optimizing manufacturing processes, reducing waste, and enhancing productivity augmenting operational efficiency and effectiveness. Quality assurance is essential to ensure that pharmaceutical products are safe, effective, and meet quality standards. The integration of operational excellence and quality management systems can help achieve pharmaceutical product quality and operational excellence goals. This chapter elaborates upon the intricate concept of quality assurance in the pharmaceutical industry, with a meticulous focus on the manifold perspectives that undergird its implementation. It underscores the paramount importance of quality assurance in ensuring the safety and efficacy of pharmaceutical products and expounds upon the regulatory frameworks that have been instituted to ensure compliance. This chapter also scrutinizes the multifarious challenges that the pharmaceutical industry faces in implementing quality assurance, including the exigency of a robust quality management system, the salience of risk management, and the pivotal role of technology in ensuring quality. In sum, this chapter provides a comprehensive, all-encompassing overview of quality assurance in the pharmaceutical industry and its indispensability in guaranteeing the safety and efficacy of pharmaceutical products.

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Department of Pharmaceutical Quality Assurance, Sinhgad Technical Education Society’s, Smt. Kashibai Navale College of Pharmacy (Kondhwa), Savitribai Phule Pune University, Pune, India

Minal Ghante, Shrikant Dargude & Vidhya Bhusari

Department of Pharmaceutics, Sinhgad Technical Education Society’s Smt. Kashibai Navale College of Pharmacy (Kondhwa), Pune, India

Arpana Patil

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Department of Pharmaceutical Quality Assurance, Smt. Kashibai Navale College of Pharmacy, Pune, Maharashtra, India

Minal Ghante

Manohar Potdar

Vidhya Bhusari

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Ghante, M., Dargude, S., Patil, A., Bhusari, V. (2024). Introduction: Quality Assurance from Perspective of Pharmaceutical Industry. In: Ghante, M., Potdar, M., Bhusari, V. (eds) Modern Aspects of Pharmaceutical Quality Assurance. Springer, Singapore. https://doi.org/10.1007/978-981-99-9271-3_1

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Quality Assurance in Pharmaceuticals: Ensuring Safe and Effective Medications

Quality assurance is a critical aspect of pharmaceutical manufacturing that ensures the production of safe, effective, and consistent medications. It encompasses a set of processes, procedures, and systems that are designed to maintain and improve product quality throughout the entire lifecycle of a pharmaceutical product. The pharmaceutical industry is highly regulated, and adherence to stringent quality assurance practices is essential to meet regulatory requirements and maintain the trust of patients and healthcare providers. In this comprehensive blog post, we will explore the world of quality assurance in pharmaceuticals, discussing its importance, key principles, regulatory guidelines, best practices, and its pivotal role in safeguarding public health. Join us on this journey to understand how robust quality assurance practices contribute to the success of pharmaceutical companies and the delivery of safe and effective medications to patients worldwide.

• Understanding Quality Assurance in Pharmaceuticals
• Definition and Significance of Quality Assurance:

Define quality assurance in the context of the pharmaceutical industry and its critical role in ensuring product quality and patient safety.

Discuss the importance of quality assurance in meeting regulatory requirements and maintaining the reputation of pharmaceutical companies.

• Key Principles of Quality Assurance:

Quality Management Systems (QMS): Explain the principles of implementing a robust Quality Management System to ensure consistent product quality.

Risk Management: Discuss the integration of risk management strategies in quality assurance to identify and mitigate potential risks.

• Role of Quality Assurance in the Pharmaceutical Lifecycle:

Research and Development: Explain the involvement of quality assurance in the early stages of drug research and development.

Manufacturing and Quality Control: Discuss the role of quality assurance in pharmaceutical manufacturing and the implementation of quality control measures.

• Regulatory Requirements for Quality Assurance in Pharmaceuticals
• FDA Requirements for Quality Assurance:

cGMP Regulations: Explore how current Good Manufacturing Practices (cGMP) regulations by the FDA mandate quality assurance as a critical aspect of pharmaceutical manufacturing.

FDA Guidance Documents: Discuss relevant FDA guidance documents related to quality assurance, such as ICH Q10 – Pharmaceutical Quality System.

• ICH Guidelines:

International Council for Harmonisation (ICH): Explain the role of ICH in harmonizing global regulatory requirements and guidelines for quality assurance in pharmaceuticals.

ICH Q8-Q11 Guidelines: Explore the ICH guidelines related to pharmaceutical development, quality risk management, and analytical validation.

• Other Global Regulatory Authorities:

European Medicines Agency (EMA): Discuss EMA’s requirements and guidelines for quality assurance in pharmaceutical manufacturing and distribution.

Health Canada and Other Regulatory Authorities: Highlight the expectations of other regulatory authorities, such as Health Canada, PMDA (Japan), and TGA (Australia), regarding quality assurance.

III. Best Practices in Quality Assurance in Pharmaceuticals

• Implementation of Quality Management Systems (QMS):

QMS Components: Explain the key components of a comprehensive Quality Management System, including documentation, training, and change control.

QMS Audits and Self-Inspections: Discuss the importance of conducting regular audits and self-inspections to assess the effectiveness of the QMS.

• Risk-Based Approach to Quality Assurance:

Principles of Risk-Based Quality Assurance: Explain the principles of risk-based quality assurance, focusing resources on critical areas that pose the highest risks to product quality and patient safety.

Risk Assessment Methods: Discuss various risk assessment tools, such as Failure Mode and Effects Analysis (FMEA) and Hazard Analysis and Critical Control Points (HACCP).

• Process Validation:

Validation Protocols: Explain the process of conducting process validation studies to ensure consistent drug manufacturing and adherence to specifications.

Continued Process Verification (CPV): Explore the concept of CPV, where the manufacturing process is continuously monitored and verified.

• Supplier and Vendor Qualification:

Supplier Qualification: Discuss the importance of qualifying suppliers and ensuring they meet quality standards to ensure the integrity of raw materials and components.

Vendor Audits: Explain the conduct of vendor audits to assess the capabilities and quality systems of suppliers and contract manufacturers.

• Quality Control and Analytical Testing
• Analytical Method Validation:

Importance of Analytical Method Validation: Discuss the criticality of validating analytical methods to ensure the accuracy, reliability, and precision of test results.

Method Validation Parameters: Explain the parameters considered in analytical method validation, such as specificity, accuracy, precision, linearity, and robustness.

• In-Process Control:

Role of In-Process Control: Discuss the importance of in-process control during drug manufacturing to monitor critical parameters and ensure product quality.

Control Charts and Statistical Process Control (SPC): Explore the use of control charts and SPC in monitoring and controlling manufacturing processes.

• Deviation and Non-Conformance Management
• Deviation Management:

Definition of Deviations: Explain deviations in the context of quality assurance and their potential impact on product quality and patient safety.

Investigation and Corrective Actions: Discuss the process of investigating deviations and implementing corrective actions to ensure product integrity.

• Non-Conformance Management:

Non-Conformance Reporting: Explore the process of reporting non-conformances in manufacturing processes and the importance of documenting these incidents.

Root Cause Analysis: Discuss the use of root cause analysis to identify the underlying reasons for non-conformances and prevent their recurrence.

• Data Integrity and Documentation
• Data Integrity in Quality Assurance:

Importance of Data Integrity: Discuss the significance of data integrity in pharmaceutical manufacturing to ensure the accuracy and reliability of data.

Data Integrity Controls: Explain the implementation of data integrity controls, such as electronic signatures and audit trails, to prevent data manipulation.

• Good Documentation Practices (GDP):

GDP Guidelines: Explore the guidelines for good documentation practices in pharmaceutical manufacturing and quality assurance.

Documentation Retention: Discuss the retention of essential documents, records, and data for future reference and regulatory inspections.

VII. Training and Education

• Training of Personnel:

Importance of Training: Discuss the critical role of training in maintaining a competent and skilled workforce in pharmaceutical manufacturing and quality assurance.

Training Programs: Explain the development and implementation of training programs to ensure continuous learning and skill development.

VIII. Quality Audits and Inspections

• Internal Quality Audits:

Purpose of Internal Audits: Discuss the purpose of internal quality audits to assess the effectiveness of the Quality Management System and identify areas for improvement.

Audit Planning and Execution: Explain the planning and execution of internal quality audits, including preparation of audit checklists and conducting interviews.

• Regulatory Inspections:

Preparing for Regulatory Inspections: Discuss the preparations required for regulatory inspections by health authorities, such as the FDA and EMA.

Handling Inspections: Explore how pharmaceutical companies should handle regulatory inspections and interact with inspectors.

• Continuous Improvement and Risk Management
• Continuous Improvement in Quality Assurance:

Kaizen and Lean Principles: Discuss the application of Kaizen and Lean principles in quality assurance to drive continuous improvement and reduce waste.

Six Sigma Methodologies: Explore the integration of Six Sigma methodologies to identify and eliminate process variations that affect product quality.

• Quality Risk Management:

Risk Management Tools: Explain the use of various risk management tools, such as FMEA and risk matrices, to assess and mitigate risks in pharmaceutical manufacturing.

Quality Risk Management Plans: Discuss the development of risk management plans to ensure proactive risk mitigation strategies are in place.

In conclusion, quality assurance in pharmaceuticals is a fundamental pillar that ensures the safety, efficacy, and consistency of medications delivered to patients worldwide. By adhering to stringent regulatory requirements, implementing robust quality management systems, and embracing continuous improvement strategies, pharmaceutical companies can maintain product quality, compliance, and patient trust. The commitment to quality assurance from drug research and development to manufacturing and distribution is essential to the advancement of global healthcare and the delivery of innovative therapies that improve and save lives. As the pharmaceutical industry continues to evolve, the principles of quality assurance remain constant, reinforcing the commitment to delivering safe and effective medications to those in need.

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Ph.d – pharmacy.

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Farewell to phd scholar saurabh mundra., admissions 2017, iccd3 2-4 march 2017- some glimpses, department of pharmacy at bits pilani, pilani camp..., applications are invited from the eligible candida..., jrf position in dst-rajasthan project (dr. anupama..., jrf position in industry sponsored project on “n..., phd admission in i sem 2018-19, bits m. pharm-2018 advertisement, applications are invited from suitable candidates ..., dr anil jindal conferred with eudragit award 2017 ..., mr. ginson george (ph.d. scholar working with dr. ..., bits admission test – 2019 “bitsat-2019..., phd short listing criteria, phd admission in i sem 2019-20, jrf positions under dr. deepak chitkara and dr. an..., jrf for “the office of principal scientific advi..., dst inspire fellowship to mr. prashant auti (phd r..., dr. p.d. sethi memorial national award 2019 confer..., call for research position (jrf / srf) in indo-aus..., ph.d admission in first semester 2021-22, world pharmacist day celebrated on 25th september ..., applications are invited from interested and motiv..., mr. arihant kumar singh, phd scholar working with ..., mr. s n c sridhar (ph.d research scholar working w..., phd admission in ii sem 2018-19, jrf position in an icmr sponsored project under dr..., dr. atish t. paul conferred the “best professor ..., guest lecture delivered by dr. sanyog jain, associ..., miss arisha mahmood (m.pharm, ii semester ) won th..., jrf position under dr. anupama mittal in icmr spon..., jrf position under dr. paul atish tulshiram in dst..., jrf position under prof. ranendra n. saha (pi) &am..., mr. kishan s italiya (ph.d. research scholar) work..., a two day workshop on pharmacokinetic & pharma..., ph.d admission in first semester 2020-21, pharmacist day celebrated at department of pharmac..., international virtual conference on drug discovery..., 03 phd scholars (department of pharmacy) selected ..., virtual conference on regulatory aspects and intel..., prof. rajeev taliyan conferred the nams membership..., miss violina kakoty, phd scholar working with prof..., ms. paramita saha (ph.d. scholar working under dr...., virtual conference on pharmacy: always trusted for..., deepak kumar sahel, phd scholar with prof. deepak ..., deepak kumar sahel, ph.d. student working with pro..., ms. shreeya p shah (b. pharm. 2ndyear) working wit..., disso research presentations india (drpi) 2022, department of pharmacy, bits pilani has organised ..., dr. raj kumar gupta visited raman research instit....

10 August, 2023 | Pilani

Dr. Manjula Devi visited IISC Bangalore for a coll...

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3 August, 2023 | Pilani

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Pilani, Hyderabad

Department of Pharmacy at BITS (Pilani) always had a excellent placement record with 90% placement of M.Pharmacy students  in reputed companies like Dr. Reddys Laboratorie (Hyderabad), Lupin Research Park (Pune), Novartis (Hyderabad), GlaxoSmithkline (Gurgaon), Torrent Pharma (Ahmedabad), Ranbaxy (Gurgaon), Evalueserve (Gurgaon), TCS Life Sciences (Hyderabad) with an average package of 5-6 lakh/annum.

The Department is continuously undertaking research projects funded by industries and governmental funding agencies like DST, DBT, ICMR and CSIR. Presently, there are 51 full time and 06 part-time Ph.D. students registered in the department.

Research Areas

The Department lays special emphasis on research work in various areas of specialization that include:

• Pharmaceutics and Pharmacokinetics
• Pharmaceutical Chemistry, Natural Drugs and Phyto-Chemistry
• Pharmacology and Toxicology
• Pharmaceutical Analysis and Quality Assurance
• Clinical Research and Clinical Pharmacy
• Pharmaceutical Biotechnology
• M.E./M.Tech./M.Pharm./MBA/M.Phil. or an equivalent Degree with a minimum of 60% aggregate in the qualifying examination.
• M.Sc./B.E./B.Pharm. or an equivalent degree with a minimum of 60% aggregate in the qualifying examination.
• For admissions to Humanities and Social Sciences, candidates with anM.A. degree and a minimum of 55% aggregate may apply.
• Full-time PhD students admitted into the PhD program are eligible to be considered for an Institute fellowship of Rs. 28,000 or Rs. 31,000 per month in the first year based on their qualifications at the time of admission.
• Students admitted with M.E./M.Tech./M.Pharm./MBA/M.Phil. or an equivalent Degree are eligible to receive an Institute fellowship of Rs. 31,000/-.
• Students admitted with M.Sc./B.E./B.Pharm. or an equivalent degree are eligible to receive an Institute fellowship of Rs. 28,000/-. These students on successful completion of coursework will receive Rs. 31,000/- from the Semester following the one in which the course work was completed.
• Higher fellowship may be made available in subsequent years. Consideration for Institute fellowship will be as per Institute norms. It will be obligatory on the part of every admitted Full time student to undertake 8 to 10 hours (per week) of work as assigned to him/her by the institute.

To learn more about the Ph.D admissions process at BITS Pilani, please visit the website https://www.bitsadmission.com

Anil Jindal

Associate Professor, Department of Pharmacy, BITS Pilani, Pilani Campus

Pharmaceutics

Assistant Professor (Off Campus), Department of Pharmacy and Biological Sciences Group, BITS Pilani

Dr. Abhijeet Rajendra Joshi  

Assistant ProfessorDepartment of Pharmacy

Peripheral neuropathy, neurodegenerative disorders, neuroscience, neuropathic pain, neuroscience lab, diabetic neuropathy lab, Epigenetic regulation in neuropathic pain

Dr. Akash Chaurasiya 

Development of nano-particulate based carrier system for anticancer therapeutics delivery, Development of vesicular carrier system for enhancing drug efficacy and safety, Oral Bioavailability enhancement using novel approaches, Lyophilization Technique, Differentiated Product Development (505b2 based approaches), Cancer therapeutics, Liposomes, Lipid Emulsion, LIpid Crystal, Formulation Development, Nanoparticles, 505b2

Dr. Aniruddha Roy

Drug delivery, Pharmaceutics

Dr. Anupama Mittal

Associate Professor, Department of Pharmacy, BITS Pilani, Pilani Campus Convenor, Institution's Innovation Council (IIC)

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Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal

• Manipal Academy of Higher Education, Manipal
• Manipal College of Pharmaceutical Sciences, Manipal

Organisation profile

The routine research activities of the Dept of Pharmaceutical Quality Assurance are

• Novel analytical method development for estimation/ assay of drugs and pharmaceuticals and its validation.
• Development of stability indicating assay methods
• Impurity profiling of drugs and pharmaceuticals
• Metabolome analysis and drug safety evaluation studies
• Pharmacokinetic evaluation
• Bioavailability studies
• Crystal engineering and material analysis
• Amorphous and co-crystal formulation development and bioavailability studies

The department houses instruments such as HPLC, GC-MS, LC-MS, UV Spectrometer, Spectrofluorimeter, IR spectrometer, ELISA system, Nitrogen evaporator, -80 refrigerator and pH meter.

Funded research projects ongoing with the department are

• Metabolite analysis and its implication on therapy, funded by DST-SERB.
• Estimation of PPRCs in waste water and effectiveness of removing these from the waste water, funded by BRNS
• Newborn screening project in collaboration with the Dept of Biochemistry and the Dept of Neonatology, KMC, Manipal, funded by VGST and Grand Challenges Canada.

The department has signed MoU for research collaborations with

• University of Copenhagen in the area of crystal engineering
• Glaxo Smith Kline Pharmaceuticals
• Novartis in the area of regulatory affairs

UN Sustainable Development Goals

In 2015, UN member states agreed to 17 global Sustainable Development Goals (SDGs) to end poverty, protect the planet and ensure prosperity for all. Our work contributes towards the following SDG(s):

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• drugs INIS 100%
• Drug Pharmacology, Toxicology and Pharmaceutical Science 55%
• pharmaceuticals INIS 53%
• hplc INIS 48%
• validation INIS 48%
• solids INIS 42%
• evaluation INIS 42%
• stability INIS 37%

Collaborations and top research areas from the last five years

Dive into details.

Select a country/territory to view shared publications and projects

Krishnamurthy Bhat

• Centre of Excellence in Drug Regulatory Affairs - Coordinator
• Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal - Professor

Person: Academic

Sudheer Moorkoth

• Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal - Professor & Head

Athira R Nair

• Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal - Assistant Professor

Research output

• 2978 Citations
• 207 Article
• 31 Review article
• 1 Comment/debate

Research output per year

Physicochemical interaction of rifampicin and ritonavir-lopinavir solid dispersion: an in-vitro and ex-vivo investigation

Research output : Contribution to journal › Article › peer-review

• in vitro 100%
• interactions 100%
• investigations 100%
• solids 100%

Recent advancements in nanoconstructs for the theranostics applications for triple negative breast cancer

Research output : Contribution to journal › Review article › peer-review

• Triple Negative Breast Cancer 100%
• applications 100%
• cancer 100%
• breasts 100%
• theranostics 100%

Shelf life determination of Khushmanda Rasayana towards scientific evidence for the chemical stability

• Chemical Stability 100%
• Catechin 100%
• Piperine 100%
• stability 100%
• storage life 100%

Differential Scanning Calorimtere

Sudheer Moorkoth (Manager)

Facility/equipment : Equipment

• sensors 100%
• thermocouples 100%
• Heat Detector 100%
• Thermocouple 100%

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• News & Events for Human Drugs
• Pharmaceutical Quality Symposium 2021: Innovations in a Changing World - 10/26/2021

Symposium | Virtual

Event Title Pharmaceutical Quality Symposium 2021: Innovations in a Changing World October 26 - 27, 2021

KEYNOTE SPEAKER

Janet Woodcock M.D. Acting Commissioner of Food and Drugs Food and Drug Administration

Visit CDER Small Business and Industry Assistance Webpage

ABOUT THIS SYMPOSIUM Please join us at this symposium, in a commitment to quality for the benefit of patients and consumers. A part of the SBIA Regulatory Education for Industry (REdI) series, the symposium will address the latest developments in pharmaceutical quality and highlight ways in which innovations have been embraced in a changing world. Speakers will:

• Share lessons learned from the COVID-19 public health emergency.
• Describe recent regulatory innovations related to pharmaceutical quality.
• Connect science and research to regulatory actions.
• Explain how the FDA is supporting the use of new technologies in the manufacture of pharmaceuticals.

TOPICS COVERED

• Learning From the COVID-19 Public Health Emergency, including a panel discussion of FDA leaders
• Innovations at FDA
• A Foundation of Science
• Advancing Advanced Manufacturing

INTENDED AUDIENCE

• Healthcare professionals interested in the FDA’s work on pharmaceutical quality.
• Manufacturing professionals
• Regulatory affairs professionals
• Foreign regulators

FDA RESOURCES

• FDA’s Office of Pharmaceutical Quality
• Report on the State of Pharmaceutical Quality: Fiscal Year 2020
• FDA’s Office of Pharmaceutical Quality Annual Report: 2020
• Pharmaceutical Quality Resources
• Facts About the Current Good Manufacturing Practices (CGMPs)

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Best Ph.D Pharmaceutical Quality Assurance Colleges in India

Gender diversity.

Swarrnim Startup and Innovation University - B.Pharma 2024

Among top 50 in India (ARIIA Rankings)

Centurion University B.Pharma Admissions 2024

Highest Package 13.8 LPA | 6000+ Placements | 200+ Recruiter | 90% placement

Chandigarh University Admissions 2024

NAAC A+ Accredited | Scholarships worth 170 CR

MAHE- Pharmacy Admissions 2024

NAAC A++ Grade, Ranked #6 India by NIRF 2023 | Accorded Institution of Eminence by MoE, Govt. of India

BITS, Pilani | BITSAT 2024

Institute of Eminence (IOE) by Govt. of India | Merit Based Scholarships | Ranked #18 by NIRF | Last Date: 11 Apr'24

KL University B.Pharma Admissions 2024

A++ Grade by NAAC | Recognized as Category-1 University by UGC | 100% Placement, 60 LPA Highest CTC, 300+ Recruiters

• Pharmaceutical Quality Assurance

Al-Ameen College of Pharmacy, Bangalore

• Ph.D ( 7 Courses )

Delhi Pharmaceutical Sciences and Research University, New Delhi

Isbm university, gariyaband.

• Ph.D ( 1 Course )

Top Institutes Accepting Applications

Ranked amongst top 3% universities globally (QS Rankings)

1000+ Recruiters | 450+ Patents | 50000+ Alumni network

Ranked #6 by NIRF 2023 | More than 85% of placements in the core companies

Ranked as India’s #1 Not for profit pvt. University by India Today.

Jamia Hamdard, New Delhi

• Ph.D ( 11 Courses )

Filter by State

• Chhattisgarh

MSU Baroda - Maharaja Sayajirao University of Baroda, Vadodara

• Ph.D ( 3 Courses )

OPJS University, Rajgarh

• Ph.D ( 13 Courses )

RK University, Rajkot

• Fees : ₹ 5.10 Lakhs
• Ph.D ( 5 Courses )

School of Pharmaceutical Education and Research, Jamia Hamdard, New Delhi

Filter by city, shridhar university, pilani, upcoming pharmacy exams.

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( KAHER-AIET ) KLE Academy of Higher Education and Research All India Entrance Test

Online Mode

( UPESPAT ) University of Petroleum & Energy Studies Pharma Aptitude Test

Application Date - Last date to apply

• Slot Booking

( CG PPHT ) Chhattisgarh Pre Pharmacy Test

( niper jee ) national institute of pharmaceutical education and research joint entrance exam.

• Application Process

( GPAT ) Graduate Pharmacy Aptitude Test

( ts eamcet ) telangana state engineering agriculture and medical common entrance test.

Others - Last date for submission of online applications with late fee of Rs. 500/-

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Popular Study Abroad Exams

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