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  • Product Related Substances

    (ICH Q6B) Molecular variants of the desired product formed during manufacture and/or storage which are active and have no deleterious effect on the safety and efficacy of the drug product. These variants possess properties comparable to the desired product and are not considered impurities.
  • Product Specification

    Inherent attributes that define the product itself, such as density, color, pH, purity, etc.
  • Product Specification

    (IEEE) A document which describes the as built version of the software.
  • Product Tracking and Genealogy

    Provides the visibility to where work is at all times and its disposition. Status information may include who is working on it; components, materials by supplier, lot, serial number, current production conditions, and many alarms, rework, or other exceptions related to the product. The on-line tracking function creates a historical record, as well. This record allows traceability of components and usage of each end product.
  • Product Variant

    A different configuration of the protein of interest, such as a dimer; sometimes the variant is the product, as in the case of hemoglobin, which is a 4-mer of myoglobin.
  • Product Water

    The water produced as a result of a treatment process.
  • Production

    (ICH Q7) All operations involved in the preparation of an API from receipt of materials, through processing and packaging of the API.
  • Production Batch

    (ICH Q1A (R2)) A batch of a drug substance or drug product manufactured at production scale by using production equipment in a production facility as specified in the application.
  • Production Cell Culture

    A culture of cells intended for use in production; it may be derived from one or more containers of the working cell bank (working cell seed) or it may be a primary cell culture.
  • Production Cells

    (ICH Q5A (R1)) Cell substrate used to manufacture product.
  • Production Database

    The computer file that contains the establishment's current production data.
  • Production Report

    Information in human readable form, presented via electronic, paper or hybrid format for activities such as review, disposition, investigation, audit and analysis.
  • Production Unit

  • Produit (PDA) (1), (ISO) (2)

  • Produkt (PDA) (1), (ISO) (2)

  • produktberührende Teile

  • produktkritisches Instrument

  • Profilometer

    An instrument for the measurement of the degree of surface roughness.
  • Proforma Invoices

    An invoice presented by one company to another for payment for goods prior to their dispatch.
  • Progeny Testing

    For a single locus: the practice of ascertaining the genotype of an individual from its offspring, such as by mating it to other individuals and examining the progeny. For a quantitative trait: the collection and use of progeny performance as a clue to the breeding value of the parent of those progeny.
  • Progesterone

    A hormone produced primarily by the corpus luteum of the ovary, but also by the placenta, that prepares the inner lining of the uterus for implantation of a fertilized egg cell.
  • Program

    A group of related projects managed in a coordinated way to facilitate effective management and control.
  • Program

    Loosely, to write a routine.
  • Program

    Loosely, a routine.
  • Program

    (ANSI) In programming languages, a set of one or more interrelated modules capable of being executed.