Webinar On Current Regulatory Requirements for Aseptically Produced Products

Description :

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 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.

Areas Covered in the Session :

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:

Drug manufacturers

Contract manufacturing companies

Sterile product vendors

Quality assurance

Quality control

Manufacturing

Validation

Production

Regulatory compliance