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You are here: Home / ALL NEWS / SOCMA Issues Support for Generic-Drug User Fees

SOCMA Issues Support for Generic-Drug User Fees

March 8, 2012 By Steven Perez

The Bulk Pharmaceuticals Task Force (BPTF), an affiliate of the Society of Chemical Manufacturers and Affiliates (SOCMA), issued its support for the introduction of a House bill, the Generic Drug and Biosimilar User Fee Act (HR 3988), which SOCMA says will help to achieve parity between foreign and domestic firms.

In its statement, SOCMA said that up to 40% of all drugs Americans take are imported, and up to 80% of the APS in those drugs come from foreign sources. The Government Accountability Office says it would take FDA nine years to inspect all foreign facilities, according to the SOCMA statement.

Read more about the Society of Chemical Manufacturers and Affiliates issued its support for the introduction of a House bill at PharmTech.com

Filed Under: ALL NEWS, All Services, Analytical Testing News & Updates | ADPEN Laboratories, Pharmaceutical Links Tagged With: analysis, Analytical, FDA, pharmaceutical, products, Testing

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ISO/IEC 17025 is a company level accreditation based on a standard published by the International Organization for Standardization (ISO) titled “General requirements for the competence of testing and calibration laboratories”. ISO/IEC 17025 is a general umbrella term used to refer to the specific standard; the current version of this standard is ISO/IEC 17025:2017. The standard contains two main sections: management requirements (primarily related to the operation and effectiveness of the quality management system within the laboratory) and technical requirements (primarily related to the competence of staff and calibration of equipment). The standard also gives requirements related to quality management such as document control and corrective action. This standard is the basis for accreditation from an accrediting body.

ADPEN has also been inspected by the US-EPA and US-FDA multiple times with no observations.

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