In order to reduce cost of production, many organizations are reexamining the need for testing raw materials. Many manufacturing processes provide a hostile environment for the growth of microorganisms and low risk of microbial contamination. This is true of raw materials that are chemical synthesized. The same cannot be said of those materials that are sourced from natural materials. Moreover, some microorganisms survive even in harshest environments. Each organization must assess the risk between reliance on its processes to remove microbial contaminants and the risk of potential recalls and/or patient welfare. Raw materials are often the major source of microbial contamination that is introduced into the manufacturing process, and some of these pose a risk to the product and patient. That is why regulators from around the world have established bioburden limits, and call for absence of certain microorganisms. The presence of these microorganisms does not only pose threat to the patient in terms of health, but it also causes product spoilage.
This webinar will address the regulatory and industry viewpoints on the subject, and the rationale why each organization, as part of its risk management program, should assess the hazard that raw materials pose to its products and manufacturing processes. Ultimately, the focus should be on both patient safety and regulatory requirements.
- What is a raw material and where it comes from
- Regulatory expectations and requirements
- Industry perspective
- Processing of raw materials during manufacturing
- Risks associated with raw materials
- Determining acceptance criteria
- Managing your suppliers
- Examples from recent history
- Quality Assurance personnel
- Quality Control personnel
- Microbiology professionals
- Regulatory and Compliance Management
- Senior Management responsible for making final decisions