Aseptic Process Validation: Top-Tips for Compliance and Success

Aseptic process validation is what gives manufacturers confidence in a safe, effective finished product, and the work starts with achieving the right sterility assurance for active ingredients and sterile bulk material. This 90-minute aseptic process validation training reviews cGMP requirements and guidance from the FDA, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) and the EU.

You'll cover the elements of a complete aseptic validation, from container closure integrity and sterilization, filter validation and equipment cleaning to sterility testing, personnel training and environmental monitoring. The session explains media fills and process simulations for liquid, semi-liquid and solid dosage forms, their acceptance criteria, and worst-case conditions and critical interventions.

It also discusses prospective, concurrent and retrospective validation, revalidation, best practices and common deficiencies.

• Interpret FDA, EU and PIC/S requirements for aseptic processing
• Identify every element of a complete aseptic validation
• Explain the importance of media fills to sterility assurance
• Choose methods for simulating aseptic processes for different dosage forms
• State media fill validation requirements and acceptance criteria
• Identify worst-case conditions and critical interventions

Regulatory requirements

• FDA, EU and PIC/S guidance on aseptic processing

Elements of a complete aseptic validation

• Container closure integrity
• Container closure sterilization
• Filter validation
• Equipment cleaning and disinfection
• Equipment maintenance and testing
• Sterility testing
• Personnel training
• Environmental monitoring

Media fills

• Why media fills and process simulations matter for sterility assurance
• Simulating aseptic processes for liquid, semi-liquid and solid dosage forms
• Validation requirements and acceptance criteria
• Worst-case conditions and critical interventions

Validation approaches

• Prospective, concurrent and retrospective validation
• The role of revalidation
• Industry best practices and common errors and deficiencies

Gaps in aseptic validation put sterility assurance and compliance at risk, and regulators expect every element to be covered. Understanding the requirements and common errors helps you build a validation program that stands up to inspection.

This session suits operations employees involved in manufacturing, quality control testing and validation, including production, QC microbiology, engineering and validation, facilities and maintenance, and quality assurance.

Operations employees participating in manufacturing, quality control testing, and validation as part of their job function will find this course highly beneficial. This includes employees in the following functions:

• Production
• QC Microbiology
• Engineering & Validation
• Facilities / Maintenance
• Quality Assurance

Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.

Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.