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Linde understands the complexity in the pharmaceutical industry with regard to compliance with all the FDA regulations. Linde has provided a large array of products for many years that fulfilled the FDA requirements for products sold in the United States. With today's global economy, new standards are emerging where compliance is required for medical products sold into different parts of the world.
The list of standards continues to grow and Linde continues to be on the forefront of regulatory compliance. Please contact Linde if you currently require these products or if you project future requirements for other products in order to comply with future standards.
EP & JP Pharmacopoeia - Introducing ... VERISEQ® PGC
The liquid products covered in VERISEQ® PGC are produced according to written and documented manufacturing procedures. VERISEQ® Gases include the liquid gases nitrogen, oxygen, and carbon dioxide. The use of these liquid products increases security and saves time during pharmaceutical and API production.
Linde realizes it is important to our pharmaceutical customers manufacturing and shipping medical products to Europe that these products are manufactured in accordance with the EP Pharmacopoeia. For this reason, Linde began testing to the EP Pharmacopoeia in 1999 at our Canton, Ohio Air Separation Plant.
Since then, the testing has expanded to several other Linde ASU's throughout the world and continues to expand. EP Compliance has become a company initiative to meet our specific customer requirements throughout the entire pharmaceutical community. Currently, Linde follows the EP monograph and testing procedures and re-validation is required in the event a piece of equipment is changed or significantly modified.
JP Pharmacopoeia is quickly becoming more important to our pharmaceutical partners. Any medical products being manufactured and shipped into Japan require that they are manufactured in accordance with the JP Pharmacopoeia and require the use of JP Nitrogen. Linde has been proactive in meeting this demand and has rolled out JP Grade N2 to some of our air separation plants as of January, 2004.