Process Analytical Technology
Permissible Daily Exposure
Pharmacopoeial Discussion Group
Documentation that provides traceability of the material throughout the supply chain. [33]
European Pharmacopoeia
Preliminary Hazard Analysis
Pharmaceutical Research and Manufacturers of America
Pharmaceuticals and Medical Devices Agency (Japan)
Performance Qualification
Product Quality Group
Pharmaceutical Quality Practices
Harmonised IPEC-PQG Excipient Manufacturer Product Regulatory Data Sheet
Previously used in an approved drug product. [EIP]
Packaging materials which have direct contact with the excipient.
Materials, excluding solvents, used as an aid in the manufacture of an intermediate, excipient or API that do not themselves participate in a chemical or biological reaction (e.g. filter aid, activated carbon, etc.).
A system for designing, analyzing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in-process materials and processes with the goal of ensuring final product quality. [EIP]
A statistical measurement that can be used to assess whether or not the process is adequate to meet specifications. A “State of Statistical Control” can be said to exist if the random variation in test results for a process parameter is such that the calculated process capability is greater than 1.33. [CoA]
A measurable operating condition. [Significant Change]
A documented instruction to the pharmaceutical excipient manufacturing personnel directing that an operation be done.
A product derived from any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use. [Significant Change]
The California Safe Drinking Water and Toxic Enforcement Act of 1986, better known by its original name of Proposition 65, is “right to know” legislation regarding substances known to the State of California to cause cancer or birth defects or other reproductive harm. [EIP]
