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You are here: Home / ALL NEWS / Analytical Testing News & Updates | ADPEN Laboratories / FDA Publishes Guidance on Physical–Chemical Identifiers

FDA Publishes Guidance on Physical–Chemical Identifiers

October 20, 2011 By Steven Perez

Last week, FDA published a final guidance for pharmaceutical manufacturers that plan to incorporate physical–chemical identifiers (PCIDs) in solid oral dosage forms as an anticounterfeiting strategy. The guidance defines a PCID as “a substance or combination of substances possessing a unique physical or chemical property that unequivocally identifies and authenticates a drug product or dosage form.” PCIDs include inks, pigments, flavors, and molecular taggants.

Read more about the FDA’s published guidance on Physical-Chemical Identifiers at Pharmtech.com.

Filed Under: Analytical Testing News & Updates | ADPEN Laboratories, Pharmaceutical Links Tagged With: FDA, guidance, pharmaceutical, 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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