What has changed for Annex 1 – it’s implication for Sterile Manufacturing?
Barrier Technologies are 46 times mentioned in the new Draft Annex 1. The Grade A critical zone shall be protected. What does this mean in terms of Grade A air supply, surface decontamination, aseptic transfers.
Richard Denk is working at the company SKAN AG, headquartered in Allschwil in the position Senior Consultant Aseptic Processing & Containment.
Richard founded 11 years ago the Containment expert group of the ISPE D / A / CH. The Containment Group published the Containment Manual Richard was responsible for in September 2015.
Richard is member of the PDA Isolator Expert Group and publisher of the PDA Paper “Isolator Surfaces and Contamination Risk to Personnel and Patient”.
Richard Denk is chapter leader for the new ISPE Baseline Guide for ATMPs.
Furthermore, Richard is Member of the ISO TC 198 WG-9 Aseptic Isolator Group.
Richard has spent more than 20 years with the subject production of highly active / highly hazardous substances and has developed the containment pyramid.
Ziva Abraham, President and Founder of Microrite, Inc
The premise of the EU Annex 1 revision is via adoption of the principles of Quality Risk Management (QRM), to ensure that sterile products are free of microbial, particulate and pyrogen contamination. Though the intent is to provide guidance for sterile medicinal products; some of the principles and guidance can be applied other products that are not intended to be sterile. The most relevant changes in the annex are the use of appropriate current technologies, sufficient knowledge and expertise in relation to the products and assessment of contamination holistically. This presentation will highlight the changes, provide clarification and explore the impact on each system as well as the overall bearing of the changes on current practices. Sections of the revision; Personnel, Premises, Equipment, Utilities, Production Specific Technologies, Viable and Non-Viable Monitoring and Quality Control will be discussed in relation to microbiological implications due to the proposed changes.
Ziva Abraham is the President and Founder of Microrite, Inc., a California based firm providing consulting and training services for medicinal product manufacturing. The team assembled by Ziva include; facility, airflow, particulate, sterilization, quality, validation and microbiology experts. Ziva’s team participates in industry standards and guidance organizations (IEST, AAMI, ISO, ASHRAE, USP and IP) as board or expert committee members.
Ziva has over 35 years of clinical and pharmaceutical microbiology as well as mycology experience. She has received her Master’s degree in microbiology with a focus on Mycology and has conducted research on developing microbial Insecticides utilizing entomogenous bacteria and fungi towards her Ph.D degree. Her career spans from founding and managing clinical laboratories for Maccabi Medical in Israel to working with pharmaceutical and medical devices companies.
As the principal microbiologist, and a part of her technical team, Ziva has helped large and small pharma, medical device, and drug device combination as well as diagnostic companies. The roles varied from development of proactive contamination control strategies through pragmatic risk assessment, troubleshooting contamination issues and helping with FDA 483/warning letter remediation activities.
In the new Annex 1 the manufacture of sterile products is subject to special requirements in order to minimize risks of microbiological, particulate and pyrogen contamination. For this several key areas need be considered. These include facility, equipment and process design; use of appropriate current technologies to ensure protection and control of the product from potential extraneous sources of particulate; and microbial contamination such as personnel, materials and the surrounding environment. Personnel must have appropriate skills, training and attitudes with a specific focus on the principles involved in the protection of sterile product during the manufacturing, packaging and distribution processes. Processes and monitoring systems for sterile product manufacture must be designed, commissioned, qualified and monitored by personnel with appropriate process, engineering and microbiological knowledge.
This presentation illustrates some of the key challenges for industry in Implementation of contamination control strategy, updating process controls, manufacturing process and upgradation to facilities, utilities.
Dr.Nagarjuna AKULA, Presently working as Vice President & Head Quality Operations, – A division of Biotechnology, Sanofi, India.
Dr. Nagarjuna AKULA, Presently working as Vice President & Head Quality Operations, – A division of Biotechnology, Sanofi, India.
Dr. Nagarjuna AKULA possesses 29+ years’ of progressive multiskilling experience in overall Quality Operations, Regulatory Affairs, R&D Quality, Project Management & Technology transfers in leading Pharmaceutical and Biotechnology companies like Sanofi, Dr. Reddy`s laboratories Ltd and Excel Industries Ltd.
His main exposure is in sterile manufacturing of pharmaceuticals, human vaccines and Active Pharmaceutical ingredients. He has expertise in inspection preparedness and handling regulatory inspections like USFDA, MHRA, and ANVISA and experience in responding to regulatory observations / US483s. He oversees all regulatory submissions and maintains relationship with key opinion leaders and regulatory officials and acts as a key liaison between the company and regulatory authorities. He is a specialist in establishing customized quality system at R&D facilities and technology transfers. He was responsible in building quality culture across all levels of the organization by engaging and influencing people positively.
Nagarjuna holds a Ph.D. in Chemistry from JNTU, Hyderabad and published papers in national and international journals.
Dr. Nagarjuna is a member of Sanofi Pasteur Global Quality Leadership Team & Corporate Quality Council. A member of PDA as well.