Day 2 :
- Quality Assurance | The Role of c in cGMP | Current GMP Guidelines (cGMP) | Validation
Location: Doubletree by Hilton Chicago North Shore
Galaxy Consulting, USA
STERIS Corporation, USA
Paul Lopolito is a Technical Services Manager for the Life Sciences Division of STERIS Corporation (Mentor, Ohio). He currently provides global technical support related to process research cleaners, stainless steel maintenance, and contamination control, which includes field support, site audits, training presentations and educational seminars. He has over 15 years of industry experience and has held positions as a technical services manager, manufacturing manager and laboratory manager. He is a frequent speaker at industry events including INTERPHEX, PDA, ISPE, ACHEMA, AALAS, and IVT. He has published several articles and book-chapters related to cleaning validation and contamination control. He earned a BA in Biological Sciences from Goucher College in Towson, MD.
The traditional cleaning validation approach has been used for over thirty years to define and validate manual and automated cleaning within GMP manufacturing. The life cycle approach includes three stages, (1) process design, (2) performance qualification and (3) continued process verification. The cleaning life cycle approach changes the emphasis from validation to design and monitoring of the cleaning process. Monitoring of the cleaning process and a better understanding of the design process (critical parameters) promotes continuous improvements and real-time scientific based decisions to OOS results and change management. Industry tools such as QbD, risk management and PAT provide the backbone to the life cycle approach. The easy-to-follow presentation provides a checklist for any organization to successfully migrate from a traditional validation model to the cleaning life cycle approach for new products or processes. The presenter will also cover some hot topics within cleaning validation, such as establishing health based limits, visual inspection, addressing non-routine cleaning residues and stainless steel maintenance.
BDR Pharmaceuticals Internationals Pvt. Ltd., India
Title: Develop and implement effective methods of teaching and convenient procedures for the implementation of new methodology student centered learning to drive the institute to new heights by satisfying more and more students and industrial needs
Time : 10:50-11:10
A competent professional with years of industrial and Academic experience with years as executive level and in senior level of experience in Quality Assurance, Consultancy, Regulatory Affairs, Production scale up and Technology Transfer in the Pharmaceutical Industry. Expertise in carrying out various inspections, audits, and review for processes release of quality standards of goods. Proficient in managing all documentation / paperwork to ensure accuracy as per regulatory requirements.
The documentation play very important role in the present global pharmaceutical sector. This acts as barrier between all the segments of business development .Hence most of the pioneer organizations of this sector prefer to have a team of professionals to handle this activity with strong background of regulatory and process related knowledge. In the pioneer organizations this activity is handling through electronic media. But 80% of the pharmaceutical industries in India are not having the software knowledge and its applications in this regard. The present attempt is to establish and define an internal effective documentation program to ensure the competency of personals to Design, Develop, Digest, Execute, Life Cycle Management and Archive of documentation modules. Through develop and implement methods of training and convenient procedures for the implementation of documentation through new methodology of personal centered learning to drive the organizations to new heights by executing the strong documentation system which meets the requirements of regulatory bodies , easily ,effectively executable and affordable by the organizations.
Chintan V Pandya has his expertise in Quality Control and Validation since last several years. He worked as a Research Associate in research institutes as well as in many industries. He has developed and validated many methods after years of experience in research, evaluation, teaching and administration both in pharmaceutical industries and education institutions. He is the Head and Professor of Chemistry at HVPGR, Kadi – KSV (India). He has an excellent track record in academics at an institution of high repute, in research with more than 10 international research articles and presented his work in national and international conferences. He has published more than 15 research articles and books in reputed and peer reviewed journals and publications. He also associated as reviewer and Editorial Board Member with many reputed publications.
Quality control is defined as the analysis of an intermediate model to identify aspects that are unusual in some sense and that could, therefore, be a result of errors in the model building or refinement process. Any such errors need to be fixed, if possible, prior to analysis and publication of the model. Validation is the process of assessing the reliability of the final model that is about to be analyzed, published, deposited, and possibly used in follow-up studies. Quality Control is known as QC and focuses on identifying defect. QC ensures that the approaches, techniques, methods and processes are designed in the project are following correctly. QC activities monitor and verify that the project deliverables meet the defined quality standards.
Quality Control is a reactive process and is detection in nature. It recognizes the defects. Quality Control must complete after Quality Assurance. A simple, rapid, accurate and sensitive method was developed for quantitative analysis. The method showed adequate precision, the method was validated for the parameters like specificity, linearity, precision, accuracy and robustness. Accuracy is one of the most important parameters of an analytical methodology and it can be expressed as the percent recovery of known amounts of drug added to a sample. The precision refers to the variability of the results in repeated analyses of the sample under identical experimental conditions. The method was validated by evaluating the intra- and inter-day precision. The precision was calculated from an average of ten determinations of a homogeneous sample.
Universidade de Brasilia, Brazil
Time : 12:00-12:20
Andrea R C Geyer has worked for ANVISA as an Inspector since 2005. She is an Industrial Pharmacist and has completed her MSc in Biological Sciences (Biochemistry). Currently, she is pursuing her PhD in Pharmaceutical Sciences at Brasilia University, studying the most common deficiencies found during ANVISA inspections.
Statement of the Problem: Good Manufacturing Practices (GMP) main objective is managing and minimizing the risks inherent in pharmaceutical manufacture to ensure the quality, safety and efficacy of products. Pharmaceutical manufacture and regulation is an international business. Regulatory authorities and the pharmaceutical industry are seeking for maximum harmonization of GMP guidelines. The main objective of the present study is to evaluate the results of Brazilian Health Regulatory Agency (ANVISA) foreign inspections in the last two years (2015 and 2016), comparing with other regulatory authorities.
Methodology & Theoretical Orientation: Results were collected from a total of 255 inspection reports. The result of the inspection was grouped by company compliance status and country. The number and criticality of deficiencies were collected and grouped by area, according to current GMP regulation in Brazil. Deficiencies found more often were listed descriptively. In the period evaluated, 63.14% of ANVISA inspected companies were classified as satisfactory, 25.88% resulted in demand status and 12.55% of inspections concluded that the company did not comply with GMP (Unsatisfactory). In 19 inspections (10.16%), critical deficiencies were found; inspectors observed major deficiencies in 111 (59.36%); and minor deficiencies were observed in 165 (88.24%) of the inspected companies. The most common areas of deficiency were documentation (28.63%) and Premises (26.27%).
Conclusion & Significance: The pattern of deficiencies was like the findings of other regulatory agencies, showing that equivalent requirements are applied. Disclosure of the common deficiencies is a step forward on regulatory transparency, which can be useful for industry to improve GMP compliance. Therefore, producers are encouraged to allocate resources and training on these main issues, assuring quality and safe medicines supply for population.
Galaxy Consulting, USA
Time : 13:30-14:30
Eleonora Babayants is the Founder and President of Galaxy Consulting and she is a documentation management professional and hands-on consultant with over 25 years of experience in documentation and records management, document control, regulatory compliance, internal and external auditing, electronic document management systems, information governance, and change management. Her past work includes development and implementation regulatory compliance processes and procedures, leading implementation and administration of document control systems in full compliance with regulatory requirements, enabling enterprise search, improving systems information architecture, creating and implementing users training programs. She led electronic document management systems selection and deployment, administered and supported these systems, web information portals, knowledgebase applications, recommended and implemented re-structuring of the content and the information architecture of these systems. She has worked very closely with IT to do feasibility assessment and to capture users’ requirements. She wrote technical documents and created document templates. Her experience spans multiple industries including biomedical, pharmaceutical, and medical device companies.
Documentation is a critical tool for ensuring GxP/GMP compliance. This is what GMP states about document control: each manufacturer shall establish and maintain procedures to control all documents that are required. In the regulated environment which must be GxP/GMP compliant, document control is the cornerstone of the quality system. It is so important that if an external audit identifies deficiencies in the document control system, the entire organization can be shut down. There are also GMP requirements for information technology. For a drug to be produced in a GxP/GMP compliant manner, some specific information technology practices must be followed. Computer systems involved in the development, manufacture, and sale of regulated product must meet certain requirements. In the regulated industries, manufactures are required to use a change control procedure. In this workshop, we will discuss the connection between GxP/GMP and document control. We will describe details of document control procedures and the role of Quality Assurance in the documentation systems. We will review GMP requirements for information technology and how computer systems including documentation management systems must meet GxP/GMP requirements. We will also review change control procedure and how it should be used in GxP/GMP environment.