The manufacture of sterile products, whether by aseptic means or terminal sterilization, requires a thorough understanding of applicable regulations by the FDA and those by the EU if selling your products overseas. In addition, there are various guidance documents that address other issues such as closure integrity and sterility test methods that were recently revised.
Today, the regulatory requirements for sterile products are found in a “Guidance for Industry” document that was published in 2004. In addition, there are requirements found in 21 CFR 210-211 and 820. In all of these documents, the areas of importance and audit focus are:
- Equipment, utility and facility qualifications
- Validation of all sterilization processes
- Control of the environment and potential sources of contamination
- Personnel training and gowning requirements based on defined areas of cleanliness
- Laboratory controls and
- Process simulations designed to verify the acceptability of the manufacturing process and operator activities.
This webinar will discuss the most important issues that apply to sterile products in order to provide an overview for attendees to evaluate their own processes and procedures. It will not go into detail on the various sterilization methods that are used within the industry, nor will it detail how best to establish process simulations. Recent 483 observations will be reviewed to help highlight common industry deficiencies and as a reference to compare attendees current practices.
- Review the current regulatory requirements and guidance documents dealing with sterile products
- Review the expectations for aseptically produced products.
- Discuss the six quality systems that are reviewed during regulatory inspections
- Review common deficiencies cited with the manufacture of sterile drugs
- Review the importance of personnel training and control of microbiological contamination
- Drug Manufacturers
- Contract Manufacturing Companies
- Sterile Product Vendors
- Quality Assurance Departments
- Quality Control Departments
- Manufacturing Departments
- Validation Departments
- Production Departments
- Regulatory Departments