- “European regulatory guidelines for similar biological medicinal products”
The concept of similar biological medicinal products (“biosimilar” medicinal products) has been introduced in the European legislative framework by directive 2001/83/EC, as amended by directive 2003/63/EC and 2004/27/EC. This directive opens a legal route allowing the registration of medicinal products claiming to be similar to marketed biological medicinal product, with reduced amount of data to be submitted, as compared to a complete "stand-alone" dossier. Technical guidelines relevant to quality, non-clinical and clinical issues have been published by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). This presentation will review the evolution and content of the legal and regulatory frameworks of biosimilar medicinal products in the European Union.
Dr. Kowid Ho, Biologicals/Biotechnology Unit, AFSSaPS
- “Aseptic and Sterile Manufacture - Regulatory Challenges”,
Jenny Hantzinikolas, GMP Auditor, Office of Manufacturing Quality, Therapeutic Goods Administration
- "Towards A Quality Assurance System for Drug Regulatory Authorities"
This presentation covers the establishment of a quality assurance office in a regulatory agency, its mission and key dimension values, the setting of targets and key performance indicators (KPIs), and the availability of international quality system standards for benchmarking. The presentation also examines the potential challenges in the setting and running of an internal quality audit program for an agency versus that of a regulatory audit program for the industry.
Sia Chong Hock, Division Director, Manufacturing & Quality Audit Division, Health Sciences Authority |
- “Design considerations for Optimal Cleanability in API Equipment”
Regulations governing API equipment cleaning stem from the need to prevent contamination of API and adulteration of drug products. API equipment cleaning expectations are largely modifications of drug product equipment cleaning expectations. In order to optimize API equipment cleaning processes, equipment design must incorporate well-known cleanability principles to ensure that all product contact surfaces can be wetted effectively, that allow for unrestricted and sufficiently forceful cleaning solvent flow, and incorporate full residual cleaning agent drainage. This presentation will discuss design standards offered by well-established agencies such as 3-A Sanitary Standards, Inc., European Hygienic Equipment Design Group (EHDEG), or The American Society for Mechanical Engineers-Biopharmaceutical Equipment (ASME-BPE) and how they can be confidently adapted to enhance an efficient and effective capability to clean API process equipment.
Dr. Bassel Iskandarani, Director of Pharmaceutical Technology, MSD Singapore
- "Application of NIR as real time monitoring tool in API manufacturing”
This presentation examines how a Near Infra Red spectroscopy PAT was implemented as an alternative to the current technique of frequent sampling of the recovered solvent and the provision of a dedicated test tank, focusing on the following aspects - Business case assessment; Baseline measurement and operating conditions; Technology proposal; Laboratory assessment and model building; Plant installation and commissioning; Validation (PQ) and Routine Monitoring.
Mohammad Nazrin Abdul Samat, Senior Chemical Engineer, Technical Development, GlaxoSmithKline
- “API Manufacture and Cost Effective Compliance”
This presentation will review how compliance actually supports cost effective Production and Release Activities. The traditional Pharma Company silo structure can present a major barrier to compliance improvement and progress. Breaking open these silos and developing an integrated structure encompassing manufacturing and compliance objectives can streamline activities to provide significant improvements in the product supply chain cycle times thereby reducing costs whilst also maintaining a culture of GMP and continuous improvement. With Company strategic goals now consistent with the contemporary approach of regulators to systems inspections rather than top down detailed reviews. Risk Management combined with Cost Effective Compliance is therefore essential to allow companies to devote greater effort to the company’s core business of ‘Production Operations’.
Ray Collyer, Senior Consultant, SeerPharma Singapore |
- “Achieving effective containment facilities - primary and secondary containment for chemical & bio-safety applications”
This paper will concentrate on experience in bio-safety applications, and identify areas where best practice can be exploited in other sectors of our industry. Issues discussed will include Regulatory requirements; available standards; a safety assured approach; the design process – solutions & options; mock-ups, trials & type testing; installation QC and practical issues.
Gordon Farquharson, Managing Director, Critical Systems
- Presentation on Risk Management in a Biologics Facility (title to be confirmed)
- ISPE Facility of the Year Award 2009 (Sustainability) – Centocor Case Study
This presentation will present a case study on the Centocor Biologics Ireland project, which was recently awarded the ISPE Facility of the Year Award in the Sustainability category. This case study will review sustainability achievements, sustainable energy engineering (including energy efficient design and renewable energy deployment) and an overview of SEI and EED methodology. Sustainability will be reviewed from the Process, Utilities, Cleanrooms and Office design perspective. The case study will review lessons learnt in a positive interactive way that can be applied across the industry and sectors.
Con Leddy, Associate Director, PM Group |