Day 1 :
Keynote Forum
Mohammed R Khan
Synergex Consulting, Canada
Keynote: Planning to outsource manufacturing: Have you done your homework?
Time : 10:00-10:30
Biography:
Mohammed R Khan is a Quality Management Consultant and Principal Synergex Consulting in Ontario, Canada. He has earlier served as Director QA, QC & Regulatory Compliance with DuPont Pharmaceuticals, Canada, and on the Board of the Pharmaceutical Manufacturers Association of Canada, Plant Operations Section. He has also served on the DIA’s Advisory Council of North America and chaired the DIA’s Canadian Programming Steering Committee and is the recipient of the DIA Outstanding Service Award. He has served as Program Coordinator, Program Committee Member, Session Chair and Speaker at numerous national and international DIA events, as well as Presenter for the PDA, OMICS Group, IQPC, PSG Canada, UK based International Society of Ethnopharmacology, and the Indian Pharmaceutical Congresses.
Abstract:
Globally rising healthcare costs, downsizing of healthcare expenditures, expiring patents and genericization, are all affecting the profitability of pharmaceuticals and forcing companies to find more cost-efficient ways of developing the drugs as well as producing the products. Outsourcing thus emerges as a logical alternative when appropriate. Contracting-out is not free of hurdles and challenges. Selecting the right contractor, confidentiality and intellectual property protection, ensuring an efficient two-way communication, Regulatory Compliance, keeping the client up-to-date on change controls, possible personality clashes between the client’s and contractor’s personnel, all manifest as bumps and hurdles. On the other hand, the overwhelming external marketing variables and the resultant loss of profitability are forcing the industry to critically look at the way it conducts its business and define profit-oriented operational strategies. Outsourcing thus emerges as a neat fit in the business design of the pharmaceutical industry of today and tomorrow, while partially or even totally freeing the business of the burden of capital investment and fixed cost issues, while also affording the advantage of reducing the time to market.
Keynote Forum
Boyd L Summers
BL Summers Consulting. LLC, USA
Keynote: Ensure quality assurance for companies and institutions
Time : 10:30-11:00
Biography:
Boyd L Summers has completed his Bachelor of Science (BS), Business Administration at Weber State University, USA. His areas of emphasis are: Information Systems, Production and Operations Management, Quantitative Analysis and Methods, Human Resources, Economics, Business Management and Statistical Analysis and Computer Science. He is currently working as a Software Technology Consultant for Bl.summers.consulting.llc located in Seattle, Washington. With 30 years of experience in Software Engineering and a leader of multiple software development teams, he continues to solve complex technical challenges to ensure that system and software engineering problems are addressed, resolved and compliant. He is the author of the two software technology books titled; “Software Engineering Reviews and Audits.” and “Effective Methods for Software and Systems Integration. He provides Software Articles to Software Engineering Journals and magazines. He was a Speaker at OMICS conferences and is a member of the American Society Quality (ASQ).
Abstract:
Outside or inside quality assurance auditors are trained and chartered to partner with companies and/or institutions and instill quality, maintain process and product requirement compliance thru in-house audits and evaluations and to provide oversight. Auditors promote process improvements, and are an advocate to a quality culture that supports commitment to technical integrity. Vision: Quality is inclusive for creating a community working together and establishes an inspired future for business management, employees and customers. Mission: Drive the growth of our people and our business through personal and professional development focused on disciplined execution and quality. Processes and Evaluation Audit Steps are: Quality Planning, Perform Audits & Evaluations, Record and Report Audit & Evaluation results to Senior Management and organization, and employees. Quality Planning: At the start of each review period, auditors prepare for audit and evaluation planning by identifying contracts and those processes that will be evaluated during that specific review period. The identified contracts and processes evaluated during the review period require the right criteria derived from company and/or institution documentation (or associated plans and procedures). Perform Audits and Evaluations: Using criteria derived from the documentation plus plans and procedures provides the performance of the audits and evaluations planned for each month. The purpose of the audits and evaluations ensure that activities and/or tasks are completed as planned and are compliant with approved company and/or institution plans and procedures. Performing audits and evaluations includes: Review of contracts, plans and procedures to determine and select appropriate evaluation criteria; In performing the evaluations, auditors make an assessment as to whether the implemented processes are compliant or noncompliant; The auditor identifies an issue or opportunity for improvement, as a result of the audit and evaluation; Auditors are not limited to performing only the process audits and evaluations that have been planned for a given month, but can provide improvements outside the audit including discussions and suggestions for companies; Auditors to perform company process audits is to verify, analyzed, communicate, and track technical, financial/costs, schedules, contractual, customer, suppliers and external and internal risks to ensure long-term success; Interviews with employees and Senior Management to ensure quality assurance is implemented for compliance and promoting a professional environment. Record and Report Process Audit and Evaluation Results to Senior Management: Companies and/or institutions maintain historical records (electronic or paper) such that they accurately reflect the activities and status they represent. Manage configuration and control of audit and evaluation records as required by company requirements are retained records for compliance and use for future improvements. There are other and effective methods for audits and evaluations, but the number one method is to ensure “Quality Assurance is First” and the other methods come in second!
Keynote Forum
Kenneth Christie
VTS Consultants, Inc., USA
Keynote: Current FDA audit trends and most common cited drug GMP deficiencies
Time : 11:20-11:50
Biography:
Kenneth Christie has over 30 years of sterile manufacturing and regulatory GMP consulting experience in the areas of Quality Assurance and Validation Management in the pharmaceutical and biotechnology industries. Specifically, his responsibilities include quality system auditing, GMP training, and serving as a subject matter expert for aseptic manufacturing processes, equipment and utilities, medical devices, and solid dosage processes on a global basis. He also performs vendor audits, site pre-approval inspections and assists clients with addressing and correcting regulatory observations. He was the Validation Manager at Parke-Davis' Sterile Products Facility where he was involved in the review and approval of all facilities, equipment, and system commissioning/qualification activities. He had routine interaction with the FDA and European inspectors (EMEA), corporate management and third party contract manufacturing representatives. He is a speaker and trainer for several professional organizations in the US, Canada, Europe, and Asia and is a published author of several articles dealing with the challenges of aseptic processing. Additionally, he has served as a member of the ISPE’s Professional Certification (PCC) Commission as an Examination Development Committee (EDC) member.
Abstract:
The audit approaches of the FDA have changed over the years based on the findings within industry during inspections. These changes have also been the result of attempts to streamline the audit procedure and to help achieve efficiencies in trying to audit the ever increasing number of new companies on top of those existing. Preparation is still the main factor to help assure a successful audit result, and by knowing what the most common deficiencies have been, companies have an opportunity to compare their own practices and correct them where applicable. This presentation will review current and past audit approaches by the FDA, the four types of inspections performed, the regulatory forms associated with all FDA audits, what data sources are used by the FDA in preparing for their audits, common areas of focus, issues associated with data integrity, five proposed categories of “operator error” that are looked at when revieiwing investigations that cite operator error as the probable cause and the top 10 most common cited drug GMP deficiencies for the last three years (2012-2014). Attendees will have the opportunity to ask questions and actual case studies will be used to highlight various points discussed.
Keynote Forum
Danuta Radzioch
McGill University, Quebec
Keynote: Importance of characterization of variation in the secondary endpoint measures prior to the trial: A key to a successful outcome of phase 1 trial and progression to a phase 2 stage of the study
Time : 11:50-12:20
Biography:
Danuta Radzioch has been a member of “Infection and Immunity Global Health Axis and Medical Genetics and Genomics Axis within the Centre for the Translational Biology and Centre for Innovative Medicine” at the McGill University Health Centre. She brings expertise in molecular biology, host-pathogen interactions, mouse models and translational medicine. She is a Fulbright Scholar, a recipient of numerous prestigious awards, including several career awards and research grants from FRSQ, Canadian Institute of Health Research (CIHR), US Department of Defense (DoD) and the American Asthma Foundation-Sandler Program for Asthma Research (SPAR; Senior Investigator Award) and Quebec Consortium for Drug Discovery (CQDM). Following postdoctoral training at the National Cancer Institute, NIH she has joined Faculty of Medicine at McGill in 1989 and since 2003 is a full Professor at the Department of Medicine and Human Genetics. She has held positions on review boards of several granting agencies. She is a co-founder of Laurent Pharmaceutical Inc. and serves as a Scientific Officer at the Scientific Advisory Board of Laurent Pharmaceutical Inc. She is the co-author of 169 scientific papers, 180 abstracts, several book chapters, and several patents.
Abstract:
The presentation describes importance of characterization of variation in the secondary endpoint measures prior to the trial: a key to a successful outcome of phase I trial and progression to phase 2 stage of the study based on the example of the outcomes from the recently completed phase I trial study Fenretinide (4-HPR), a master regulator of lipid metabolism controlling inflammation in patients with cystic fibrosis. The presentation describes bench to clinical development of the project and back to bench study to fully explain the mechanism of action of the drug explaining its effect on secondary end points. Dr. Radzioch laboratory has been pursuing research on cystic fibrosis lung disease for more than 15 years. Cystic fibrosis disease involves multiple organ pathology causing patients to live with many symptoms such as malabsorption of nutrients, low body mass, and malfunction of the pancreas, diabetes, infertility and osteoporosis. Aberrant regulation arachidonic acid (AA, an omega-6 fatty acid) and docosahexaenoic acid (DHA, an omega-3 fatty acid) were already known in cystic fibrosis but until now there was no treatment which could correct this problem. Dr. Radzioch laboratory demonstrated that the severe aberrations in lipid metabolism also happen during severe infections and spinal cord injury. CF mice were treated with fenretinide (4-HPR); a drug previously used in cancer trials helped the CF mice to improve their ability to fight lung infection with Pseudomonas.
- Track 2 &5: Current Regulations and Quality Standards & Good Clinical Practices & Good Laboratory Practices
Track 6, 7 & 8: Quality Control, Quality Assurance & Validation
Track 9: Contract & Sterile/Aseptic Manufacturing
Track 11 & 12: Formulation Development & GMP in Food Industry
Track 14: Softwares in GMP and GCP
Session Introduction
Mohammed R Khan
Synergex Consulting, Canada
Title: Planning to outsource manufacturing: Have you done your homework?
Biography:
Mohammed Khan is a Quality Management Consultant and Principal Synergex Consulting in Ontario, Canada. He has earlier served as Director QA, QC & Regulatory Compliance with DuPont Pharmaceuticals, Canada, and on the Board of the Pharmaceutical Manufacturers Association of Canada, Plant Operations Section. He has also served on the DIA’s Advisory Council of North America and chaired the DIA’s Canadian Programming Steering Committee and is the recipient of the DIA Outstanding Service Award. He has served as Program Coordinator, Program Committee Member, Session Chair and Speaker at numerous national and international DIA events, as well as Presenter for the PDA, OMICS Group, IQPC, PSG Canada, UK based International Society of Ethnopharmacology, and the Indian Pharmaceutical Congresses.
Abstract:
Globally rising healthcare costs, downsizing of healthcare expenditures, expiring patents and genericization, are all affecting the profitability of pharmaceuticals and forcing companies to find more cost-efficient ways of developing the drugs as well as producing the products. Outsourcing thus emerges as a logical alternative when appropriate. Contracting-out is not free of hurdles and challenges. Selecting the right contractor, confidentiality and intellectual property protection, ensuring an efficient two-way communication, Regulatory Compliance, keeping the client up-to-date on change controls, possible personality clashes between the client’s and contractor’s personnel, all manifest as bumps and hurdles. On the other hand, the overwhelming external marketing variables and the resultant loss of profitability are forcing the industry to critically look at the way it conducts its business and define profit-oriented operational strategies. Outsourcing thus emerges as a neat fit in the business design of the pharmaceutical industry of today and tomorrow, while partially or even totally freeing the business of the burden of capital investment and fixed cost issues, while also affording the advantage of reducing the time to market.
Nadia Narine
Lumar Food Safety Services Ltd., Canada
Title: Traceability guide for general food manufacturers
Time : 12:20-12:50
Biography:
Nadia has 18 years of experience in various Quality Assurance/Technical roles. She has worked within a variety of food manufacturing facilities, as well as retail, which include industry’s such as bakery, confectionery and dairy. Nadia has expertise in Quality Assurance, Quality Control, food safety, and hygiene. She has strong audit and training skills. She is currently an approved auditor for GFSI standards such as BRC and SQF. In addition she is a current auditor to unaccredited standards such as the Gluten Free certification program, GMASAFE, HACCP, and GMP. Nadia is a BRC Approved Training Provider for Food and Storage & Distribution, and Agents and Brokers. Also a Lead Instructor for FSPCA Preventive Controls for Human Food . She is an auditor to (accredited and unaccredited) food standards and a certified consultant for SQF. Nadia’s educational background includes Industrial Microbiology, Marketing, Six Sigma, and ongoing courses for professional development in food safety. She is currently a member of The American Institute of Quality, and IAFP. Nadia is currently the Owner/President of Lumar Food Safety Services Ltd.
Abstract:
Food Manufacturers must ensure every part of the receiving, production, processing and distribution processes are included as part of the trace system. Facilities have a responsibility to ensure they are able to trace all raw material and finished products. It is important that all records regardless of the form are maintained and kept accessible for any complaints, withdrawals, and recalls. Typically keeping records for the shelf life plus two years is industry best practice. Testing of the trace system should be done at a minimum of annually, and should include: primary packaging, raw materials, and finished product. A raw material from the finished lot trace can be selected for a mass balance. Traceability should be done in both directions and all supporting documentation kept. Once a mock recall or mass balance has been done, it is important that any key findings that impacted the trace are incorporated back into the management system after root cause analysis has been done. Ensuring the traceability system is robust at all times. Withdrawls and Recalls often confused and used interchangeably, they differ considerably. Withdrawal is being able to effectively contain product that has been sent to a customer and not yet reached the consumer. A recall is being able to recover all product that has entered the main stream market, and is with consumers. Withdrawals can be for food safety or quality reasons and do not have a legal setting; recalls involve government and have a legal aspect as consumers are now directly impacted.
Dharmi Trivedi
Professional Pharmaceutical Quality and Compliance Specialist, USA
Title: Stability considerations from early stage development through phase-IV of pharmaceutical drug products
Time : 13:30-14:00
Biography:
Ms. Dharmi has Master’s degree in science majoring in Chemistry from Saurashtra University, India. Dharmi is a professional pharmaceutical Quality and Compliance specialist. Dharmi has over 20 years of experience in Pharmaceutical Industries including, Quality and Compliance, Quality Control and Research and development. During her career she has gained expertise in cGMP areas that include; investigations, CAPAs, change control, process validation, Quality Management System (QMS),Third party Organization (TPO) management, stability program, and external/internal audits.
Abstract:
Stability studies are key components of pharmaceutical drug products during early stage development through phase-IV that supports in establishing the drug product re-test date and shelf life by evaluating the data generated under controlled environmental storage conditions. Real time data is an ongoing stability in the drug development process while the clinical trial is ongoing and during late stage of development process. Drug manufacturer must assure that product remains stable during the course of clinical trials in early development process and it remains stable during the shelf life in late development stages and during post marketing until it reaches to the expiration date. To meet this obligation, manufacturer makes commitments to the regulatory authorities during ANDA/NDA submission. This paper describes the stability considerations of pharmaceutical drug products for early stage development (pre-clinical and Phase-1 and Phase-2), ICH stability studies to support NDA application in Phase-3 and monitoring ongoing stability and stability due to post approval changes in Phase-IV, of pharmaceutical drug product cycle.
Biography:
Peggy J Berry, MBA, RAC, is the President & CEO at Synergy Consulting, where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. Prior to founding Synergy Consulting in 2015, she was Vice President of Regulatory Affairs at Insmed where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. Prior to Insmed, she was Vice President of Regulatory Affairs and Quality at Amarin. She has also held a variety of senior level positions at Dyax (now Shire), MGI Pharma (now Eisai), AstraZeneca, and Dey Pharma (now Mylan). She has also held Regulatory Affairs roles within two clinical contract research organizations (ILEX Oncology and Cato Research Ltd) and has worked in review divisions at the FDA. In addition, she consults for a number of companies in the regulatory and quality area, conducts a number of training courses, and is active in the Regulatory Affairs Professionals Society. She is the editor of the 2010 book “Choosing the Right Regulatory Career” (RAPS, MD) and author of the 2011 book “Communication & Negotiation” (RAPS, MD).
Abstract:
Good clinical practices continue to be a major focus of Regulatory Agencies to ensure the consistency and reliability of data and the protection of human subjects. This presentation will review specific GCP requirements for sponsors, investigators, and IRBs. Providing practical guidance and successful implementation strategies, as well as oversight strategies for vendors, contractors, and clincal study sites. We will also examine evolving practices in GCPs, including electronic case report forms, patient diaries, and consent forms, risk-based monitoring, and effective project management. Examples and case studies will provide scenario-based learning for monitors, auditors and other study management personnel. Suggestions for effectively training and managing monitors, investigators and study staff will also be provided.
Jerry Lanese
The Lanese Group, Inc., USA
Title: Turning the FDA quality metrics into a proactive quality improvement tool
Biography:
John G. (Jerry) Lanese, Ph.D, is an independent consultant in the area of quality systems, quality management and FDA regulatory compliance. He has more than thirty years of experience in quality systems, quality system development, quality system audits, method development, quality control laboratory management, quality assurance, regulatory compliance and training. Jerry has a thorough knowledge of Baldrige Criteria, FDA Quality System approach, Quality System Regulation, ISO 13485, analytical instrumentation, product testing, specification development, validation, documentation review, GMPs, and quality management concepts. Jerry is currently the co-editor of GXP Talk, a continuing series of articles that appears in the Journal of Compliance.
Abstract:
In July of 2015 the FDA issued draft guidance –Quality Metrics. In this guidance the FDA informed the industry that it plans to have all firms that manufacture an API or drug product for distribution and sale in the United States to submit data that the Agency will use to calculate defined quality metrics. In reality, the FDA will be requiring the firms to review the type of data that they should have been reviewing since the 1978 release of the current GMPs. The FDA indicates that they will use the data and calculated metrics to plan a risk based inspection schedule. The firms should take this opportunity to use to identify systemic problems and monitor the effectiveness of elements of the quality system. However, if the firms collect and submit the data and calculate the same quality metrics that the FDA will be calculating in the time frame discussed in the draft guidance, they will be evaluating data up to a year old and the indicators will be lagging. Pharmaceutical firms should establish programs that proactively use the data they will have to collect for the FDA, the calculated metrics, and other appropriate data as leading indicators of problems and apply the enablers of the Pharmaceutical Quality System: Quality Risk Management and Knowledge Management to support the elements of the Pharmaceutical Quality System: Process Performance and Product Quality Monitoring, Corrective Action/Preventive Action (CAPA), Change Management System, and Management Review to support their program of continuous improvement.
Boyd L Summers
BL Summers Consulting. LLC, USA
Title: Ensure quality assurance for companies and institutions
Biography:
Boyd L Summers has completed his Bachelor of Science (BS), Business Administration at Weber State University, USA. His areas of emphasis are: Information Systems, Production and Operations Management, Quantitative Analysis and Methods, Human Resources, Economics, Business Management and Statistical Analysis and Computer Science. He is currently working as a Software Technology Consultant for Bl.summers.consulting.llc located in Seattle, Washington. With 30 years of experience in Software Engineering and a leader of multiple software development teams, he continues to solve complex technical challenges to ensure that system and software engineering problems are addressed, resolved and compliant. He is the author of the two software technology books titled; “Software Engineering Reviews and Audits.†and “Effective Methods for Software and Systems Integration. He provides Software Articles to Software Engineering Journals and magazines. He was a Speaker at OMICS conferences and is a member of the American Society Quality (ASQ).
Abstract:
Outside or inside quality assurance auditors are trained and chartered to partner with companies and/or institutions and instill quality, maintain process and product requirement compliance thru in-house audits and evaluations and to provide oversight. Auditors promote process improvements, and are an advocate to a quality culture that supports commitment to technical integrity. Vision: Quality is inclusive for creating a community working together and establishes an inspired future for business management, employees and customers. Mission: Drive the growth of our people and our business through personal and professional development focused on disciplined execution and quality. Processes and Evaluation Audit Steps are: Quality Planning, Perform Audits & Evaluations, Record and Report Audit & Evaluation results to Senior Management and organization, and employees. Quality Planning: At the start of each review period, auditors prepare for audit and evaluation planning by identifying contracts and those processes that will be evaluated during that specific review period. The identified contracts and processes evaluated during the review period require the right criteria derived from company and/or institution documentation (or associated plans and procedures). Perform Audits and Evaluations: Using criteria derived from the documentation plus plans and procedures provides the performance of the audits and evaluations planned for each month. The purpose of the audits and evaluations ensure that activities and/or tasks are completed as planned and are compliant with approved company and/or institution plans and procedures. Performing audits and evaluations includes: Review of contracts, plans and procedures to determine and select appropriate evaluation criteria; In performing the evaluations, auditors make an assessment as to whether the implemented processes are compliant or noncompliant; The auditor identifies an issue or opportunity for improvement, as a result of the audit and evaluation; Auditors are not limited to performing only the process audits and evaluations that have been planned for a given month, but can provide improvements outside the audit including discussions and suggestions for companies; Auditors to perform company process audits is to verify, analyzed, communicate, and track technical, financial/costs, schedules, contractual, customer, suppliers and external and internal risks to ensure long-term success; Interviews with employees and Senior Management to ensure quality assurance is implemented for compliance and promoting a professional environment. Record and Report Process Audit and Evaluation Results to Senior Management: Companies and/or institutions maintain historical records (electronic or paper) such that they accurately reflect the activities and status they represent. Manage configuration and control of audit and evaluation records as required by company requirements are retained records for compliance and use for future improvements. There are other and effective methods for audits and evaluations, but the number one method is to ensure “Quality Assurance is First†and the other methods come in second!
Kenneth Christie
VTS Consultants, Inc., USA
Title: Current FDA audit trends and most common cited drug GMP deficiencies
Biography:
Kenneth Christie has over 30 years of sterile manufacturing and regulatory GMP consulting experience in the areas of Quality Assurance and Validation Management in the pharmaceutical and biotechnology industries. Specifically, his responsibilities include quality system auditing, GMP training, and serving as a subject matter expert for aseptic manufacturing processes, equipment and utilities, medical devices, and solid dosage processes on a global basis. He also performs vendor audits, site pre-approval inspections and assists clients with addressing and correcting regulatory observations. He was the Validation Manager at Parke-Davis' Sterile Products Facility where he was involved in the review and approval of all facilities, equipment, and system commissioning/qualification activities. He had routine interaction with the FDA and European inspectors (EMEA), corporate management and third party contract-manufacturing representatives. He is a speaker and trainer for several professional organizations in the US, Canada, Europe, and Asia and is a published author of several articles dealing with the challenges of aseptic processing. Additionally, he has served as a member of the ISPE’s Professional Certification (PCC) Commission as an Examination Development Committee (EDC) member.
Abstract:
The audit approaches of the FDA have changed over the years based on the findings within industry during inspections. These changes have also been the result of attempts to streamline the audit procedure and to help achieve efficiencies in trying to audit the ever increasing number of new companies on top of those existing. Preparation is still the main factor to help assure a successful audit result, and by knowing what the most common deficiencies have been, companies have an opportunity to compare their own practices and correct them where applicable. This presentation will review current and past audit approaches by the FDA, the four types of inspections performed, the regulatory forms associated with all FDA audits, what data sources are used by the FDA in preparing for their audits, common areas of focus, issues associated with data integrity, five proposed categories of “operator error†that are looked at when revieiwing investigations that cite operator error as the probable cause and the top 10 most common cited drug GMP deficiencies for the last three years (2012-2014). Attendees will have the opportunity to ask questions and actual case studies will be used to highlight various points discussed.
Wael Ebied
SEDICO Pharmaceutical, Egypt
Title: Bioavailability and bioequivalence concerns in pharmaceutical industry
Biography:
Wael Ebied has completed his BPharm from Tanta University with Postgraduate studies from Al-Azhar University School of Pharmacy. He is a certified Senior Professional, SQA Services Inc., US leader in providing supply chain management, quality and engineering services to pharmaceuticals, medical devices and highly regulated industries. He has published many papers in reputed journals and has been serving as an Editorial Board Member of repute. He has more than twenty years’ experience in pharmaceutical industries, biotechnology, medical devices and APIs. He is an accomplished technical presenter with numerous projects, scientific publications, participated in some patents and was awarded many premiums.
Abstract:
To accomplish a desired systemic effect, drug molecules must reach the systemic circulation after extravascular administration. The percent of the taken dose that reaches intact to the systemic circulation is called “bioavailability, BAâ€. Absolute Bioavailability compares the BA of the active drug in systemic circulation following non-intravenous administration (i.e., after oral, rectal, transdermal, subcutaneous, or sublingual administration), with the BA of the same drug following intravenous administration. Bioequivalence (BE) is a term in pharmacokinetics used to assess the expected in vivo biological equivalence of two proprietary preparations of a drug. If two products are said to be bioequivalent it means that they would be expected to be, for all intents and purposes, the same. Toxicological studies and full-scale clinical trials are conducted to prove that the product is of good quality, safe and effective, however it could be reduced by performing BE studies. In case of minor changes of a marketed product or by manufacturers of generic drugs, we typically perform BE studies. The main test methods suitable for assessing equivalence are; comparative pharmacokinetic studies in humans, comparative pharmacodynamic studies in humans, comparative clinical trials, comparative in vitro tests or no equivalence test necessary. Biowaver is Comparative in-vitro tests as per FDA and WHO guidelines. For the two products, the biowaiver data must demonstrate: comparable impurity profiles. Respecting ICH Q3B, a long term stability study must be conducted, demonstrating that the acceptance limits for the new product do not exceed the comparator ones, in addition to equal pharmaceutical performance by dissolution testing. Compliance with any of the Dissolution, Disintegration, and Drug Release tests does not assure BE or BAâ€. The United States Pharmacopoeia (USP) 37 has recently included this statement. The USP sets standards for the dissolution but often those suggested test methods are modified by the manufacturer to meet the specific needs of the product. A dissolution profile is then constructed (Time vs Amount Dissolved) and this is compared to the reference compound or standard for the dosage form in being dissolved. An IVIVC (In-vitro in-vivo correlation ) has been defined by the FDA as "a predictive mathematical model describing the relationship between an in-vitro property of a dosage form and an in-vivo response". Solubility and BA are big challenges in drug development. There are difficulties in obtaining optimum absorption from the gastrointestinal tract (GIT) after oral administration. Excipients are generally pharmacologically inert, but can interact with drugs in the dosage form and the physiological factors at the site of absorption to affect the BA of a drug product. In the industry, we should have practical, proven approaches for overcoming these barriers to progress. Approximately 80% of the compounds at present in development for future use, and 50% of all drugs currently on the market are reported to show poor solubility in water.
Biography:
Orlando Lopez works for the past twenty five years works in the areas of worldwide pharmaceutical compliance, Part 11 remediation, and EMA Annex 11 in the production and quality control systems relevant to the manufacture of medicinal products. He is a SME on electronic records integrity and worldwide regulations applicable to computer compliance. He had papers published by ISPE's Pharmaceutical Engineering, Pharmaceutical Technology and GXP Journal magazines. He is the author of five computer compliance books, including one on EU Annex 11. He is currently writing his 6th book about the best practices on e-records integrity. This book is to be published by CRC by 2016 Q3.
Abstract:
Data Integrity is a global problem and currently a major concern in FDA and European Regulatory Agencies. To ensure the integrity of electronic records it is essential that the system managing these electronic records must be, at the same time, trustworthy. Trustworthy computer systems are the first line of defense to protect the critical electronic records managed by these systems. The driver of the computer systems validation process is to ensure an acceptable degree of evidence (documented, raw data), confidence (dependability and thorough, rigorous achievement of predetermined specifications), intended use, accuracy, consistency and reliability, or that the computer system is a trustworthy system. This presentation describes the concept of trustworthy computer systems in a GMP regulated activity and, the regulatory requirements and key guidelines associated with the trustworthy of computer systems within the scope of the referenced competent authority.
Biography:
Mark has a successful track record in delivering complex projects to a range of different customers within the regulated life science industry. Graduating in 1994 from the University of Birmingham, his career has included design engineering, commissioning / validation, project management and a whole range of GxP Compliance consulting projects around the world. He has 20 years of experience with managing teams and delivering projects that have utilised a risk based approach to achieving compliance within EU and US markets in a pragmatic and efficient manner. His consulting team specialises in EQMS, computer systems compliance, quality systems implementation and the management of complex and often business critical compliance improvement projects.
Abstract:
The need to retain information as accessible, searchable and useable goes far beyond the need to satisfy legal requirements of data longevity. There’s also arguably more onus than ever before regarding the visibility over who’s accessed what and when: something that a paper-based, manually administrated system can struggle to provide. As many compliance conscious organisations migrate from a paper-based archiving system to an electronic alternative, Mark explores the common misconceptions surrounding the journey and provides guidance on how businesses can minimise the cost implications of keeping an ever-growing population of content electronically preserved. LEARNING OBJECTIVES: At the conclusion of this presentation, participants will have an enhanced understanding of: The pitfalls of paper, compatibility and accessibility, and the benefits of an electronic quality management system (EQMS), How to select and implement an EQMS, considering the complete journey between document creation and archiving, What’s involved in migrating from paper to electronic from a cost, compliance and process perspective, The need to future-proof business critical documentation – advocating active preservation over mere safe-keeping, The options open to organisations when it comes to where to store archived digital data, and who should be responsible for it, The security and accessibility challenges surrounding both off-site but internally managed systems, and fully outsourced solutions, The latest facts and figures surrounding achieving trends across multiple regulated industries.
Mohammed Kaleemullah
Management & Science University, Malaysia
Title: Bioavailability enhancement of sulpiride from a gastro retentive drug delivery system in rabbits
Biography:
Mohammed Kaleemullah has completed his Master’s in Pharmaceutical Technology from Universiti Sains Malaysia. Presently he is working as Senior Lecturer in Department of Pharmaceutics, School of Pharmacy, Management & Science University, Malaysia. Halal Cosmetics & Pharmaceuticals and Nano Drug delivery Systems are the main area of interest and currrently supervising six research students at undergarduate level. He has published more than 30 papers in reputable journals.
Abstract:
The present study was aimed to develop, validate a simple reversed-phase high performance liquid chromatographic method for determination of sulpiride in plasma and also to evaluate in vivo performance of the optimized gastroretentive formulation in comparison with a non-gastroretentive reference product (Dogmatil®) using rabbits as an animal model. The HPLC system was operated at an excitation and emission wavelengths of 300 nm and 365 nm, respectively with the gain was set at 4 and sensitivity at medium. The mobile phase was consisted of 0.01 M phosphoric acid, acetonitrile and methanol (84:12:4, v/v) with addition of Triethylamine (0.15%v/v). The mobile phase pH was adjusted to 6 by using glacial acetic acid. The mobile phase was isocratically pumped at a flow rate of 1 mL/min. The analytical column Luna C18 (5 µm, 250 x 4.6 mm ID, Phenomenex, USA) fitted with a refillable guard column (Upchurch Scientific, Oak Harbour, WA, USA) packed with Perisorb RP-18 (30-40 µm, pellicular) was used for chromatographic separation. The mobile phase was filtered under vacuum through 0.45 µm nylon membrane filter (Whatman International, England) and degassed before used. The calibration curve was linear in the range of 15 to 4000 ng/ml with correlation coefficient (r) of 0.9999 (± 0.0001). The intra-day accuracy ranged from -4.59% to 12.91% with a precision from 1.42% to 6.79%. The inter-day accuracy ranged from -1.86% to 6.29% with a precision from 4.21% to 13.91%. The extraction recovery values were found to be 95.99 ± 9.44%, 96.12 ± 11.94% and 93.49 ± 5.13%, with precision of 9.84%, 12.42% and 5.49% respectively. The mean recovery for internal standard (metoclopramide) was 90.28 ± 3.95%. The values of accuracy, precision and recovery obtained were within the acceptable limits as proposed by USFDA Bioanalytical Guidelines. For in vivo pharmacokinetics study a balanced two-way crossover design was used using 6 rabbits. The optimized formulation had higher Tmax, and AUC0-∞ values but lower Cmax value than non-gastroretentive reference product (Dogmatil® capsule). The bioavailability of sulpiride in the optimized gastroretentive dosage form was 2.20 times higher than the non-gastroretentive reference product (Dogmatil® capsule). In addition, the amount of drug released in vitro was correlated with the amount of drug absorbed in vivo.
Ahmed Salah Aboshoukka
COPAD Pharma, Egypt
Title: Applying lean manufacturing principles to a pharmaceutical site: Case study
Biography:
Ahmed Salah Aboshoukka has been certifed as (CMQ) certifed manager of quality and organizanal excllence by ASQ in 2010. He is the Technical Director of Copad Egypt, a pharamcutical manufacturing company. He has participated in more than 25 trianing courses of cGMP and pharma manufacturing.
Abstract:
Reducing different types of waste and process improvement are shared targets of lean manufacturing and pharmaceutical guidelines (e.g. pharmaceutical quality system ICH Q10). In order to establish an integrated quality system we have used lean tools to discover areas for development and enhance continual improvement of our procedures. This project is carried out on the light of change management system to ensure adherence to cGMP and regulatory requirement in case of any variation is needed of process or system. Satisfactory results have been achieved supported with a finical analysis report.
Musbau Lasisi
May & Baker Nigeria PLC, Nigeria
Title: Comparative in vitro dissolution study of multi-sourced (generic) Ketoprofen, extended-release capsules
Biography:
Musbau Lasisi has a Bachelor’s of Science Degree in Chemistry from Obafemi Awolowo University. He is a member of the Institute of Public Analysts of Nigeria and also a member of the American Chemical Society. He is currently the Laboratory Supervisor at May & Baker Nigeria PLC, an ISO 9001:2008 and WHO-GMP certified pharmaceutical company.
Abstract:
Dissolution testing is a very important in vitro test used as a mean of in vivo predictability and product performance. Dissolution testing has become one of the most used tests in many pharmacopoeias in the characterization and quality control of drugs in solid oral dosage forms and one of the foundations of solid dosage form design. Many proprietary and generic formulations commercially marketed in Nigeria are mostly from Asian countries. Nigerians buy these products because of their relative cheap prices but with doubtful minds with regards to efficacy, quality and safety. Health professionals usually entertain drug product selection and substitution during prescription and dispensing with caution. In this paper, the in vitro dissolution on three multi-sourced (generic) ketoprofen (200mg) capsules was carried out employing the UV absorption as explained in the US Pharmacopoeia. USP Ketoprofen RS was used as the primary standard. From the results; the percentage of the labelled amount of ketoprofen dissolved after 1 hour was found to be between 15% and 21%, 65% and 73% after 4 hours and 94% to 98% was the range obtained for the percentage of the label claim of ketoprofen dissolved after 8 hours. In conclusion, the three generic formulations of ketoprofen capsules were predictably in vivo available since the percentages of the labelled amount of ketoprofen released at the times specified conform to the USP requirements. Interchangeability of drugs in prescription and dispensing may be recommended in this situation.