Compressed Gases - Vendor Audits, Safety and Testing in GMP environment

Live Web Training CoursecGMP training
Wednesday, August 11, 2010
(1:20 p.m. – 3:45 p.m. EDT)Course Details
(12:20 p.m. – 2:45 p.m. CDT)
(10:20 a.m. – 12:45 p.m. PDT)GLP
Instructor: Ziva Abraham

Gases are employed as “invisible helpers” in most areas of industry. Such areas include many ZIVA_GMP_TRAININGprocesses in the manufacture of active pharmaceutical ingredients (APIs) and pharmaceuticals. This also includes R&D, as well as production and quality control. In order for any manufacturer to be approved by the official authorities as a manufacturer of active pharmaceutical ingredients (APIs) or pharmaceutical drug products, full compliance with cGMP must be assured. In the case of industrial gases used in pharmaceutical production, drug producers must fulfill cGMP requirements in order to assure batch uniformity and integrity of the drug product.

The testing of pharmaceutical gas has been described for many years in several pharmacopeia (EP, USP). Given that the gases may be in contact with the pharmaceutical product, more attention is being focused on their role as an excipient and controlled according to the monographs. The monographs describe the specification of the gas in terms of purity and trace contamination. On industrial sites, the gases are delivered from a central unit to several user end-points. Therefore all the pipe work installation needs to be qualified and monitored to guarantee the gas quality at the point of use.

Contamination control is also an important consideration to for laboratories and production in the pharmaceutical and life science sectors. Contamination poses a significant risk to technical processes of sterile or non-sterile production, as well as to the individual.

This session will cover the points to consider when using compressed gases and qualifying vendors such as manufacturing, distribution, storage and equipment used . How to establish product specifications and documentation requirements from vendor for compressed gases at your facility which includes analysis, tankers, and documentation. This will provide pointers for auditing compressed gas vendors and ensure consistent quality of supply. Additionally this webinar will teach what to expect in certificate of analysis for each lot of compressed gases received. Safety requirements that should be considered when installing tanks or bulk delivery for compressed gases will also discussed. Learn about the regulatory requirements for testing compressed gases. Using a risk based approach establish testing criteria, and frequencies to ensure contamination free product. Learn about how to asses contamination that may be objectionable in your product.

Who should attend:

  • Microbiologists
  • QA managers
  • Manufacturing personnel
  • Cleanroom Cleaning Personnel
  • Facilities Personnel

Level:

Intermediate