Current Regulatory Requirements for Sterile Products

Why Should You Attend:

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 in 2012.

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
• Process simulations designed to verify the acceptability of the manufacturing process and operator activities

This webinar will review these key areas of the most important issues that apply to sterile products in order to help 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 attendee’ s current practices.

Areas Covered in the Webinar:

• 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

Who Will Benefit:

• Quality assurance
• Quality control
• Manufacturing
• Validation
• Production
• Regulatory Compliance

Kenneth Christie
Chief Operating Officer, VTS Consultants Inc

Kenneth Christie has over 30 years of sterile manufacturing and regulatory GMP consulting experience in the areas of Quality Assurance and Validation Management in the pharmaceutical and biotechnology industries. Mr. Christie is currently the Chief Operating Officer for VTS Consultants, Inc. located in Amherst, MA. Specifically, his responsibilities include quality system auditing, GMP training, and serving as a subject matter expert for aseptic manufacturing processes, equipment and utilities, medical devices, and solid dosage processes on a global basis. Mr. Christie also performs vendor audits, site pre-approval inspections and assists clients with addressing and correcting regulatory observations.

Mr. Christie was the Validation Manager at Parke-Davis' Sterile Products Facility where he was involved in the review and approval of all facilities, equipment, and system commissioning/qualification activities. He had routine interaction with the FDA and European inspectors (EMEA), corporate management and third party contract-manufacturing representatives to defend validation practices and to assure regulatory compliance for the manufacture of aseptically produced products.

Mr. Christie is a speaker and trainer for several professional organizations in the US, Canada, Europe, and Asia and is a published author of several articles dealing with the challenges of aseptic processing. Additionally, Mr. Christie served as a member of the ISPE’s Professional Certification (PCC) Commission as an Examination Development Committee (EDC) member. He possesses a BS degree in Biology from Shippensburg State University (PA) and an Executive MBA degree from Michigan State.

Topic Background:

Any company responsible for the manufacture of sterile products or contract manufacturing organizations that aseptically produce products for their clients are highly regulated with regards to various regulatory regulations, and guidance documents. The risk to the public is why there is so much focus on the establishment of procedures, the training on aseptic technique and the adherence to control of the environment and personnel. By understanding what auditors will look for and where resources and time need to be planned for will help assure that control is demonstrated to minimize the potential for contamination. The manufacture of sterile products also requires the control of the equipment used, the maintenance and calibration of critical systems and also the investigation of deviations as to cause and corrective and preventative actions.

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