Points to Consider documents are not regulations with the force of law, but are instead guidelines on issues that FDA believes should be considered
by regulated industry. These documents are not definitive or all-inclusive. In fact, they are presented as drafts subject
to further modification, and readers are invited to submit comments. They acknowledge that processes and associated knowledge
change with time. They suggest and recommend procedures that manufacturers should consider during development of new drugs
purification A central part of downstream processing that takes a crude fermentation supernatant or cell homogenate (a chaotic slurry
of tissues and cells) and isolates the product from it in a fairly pure form.
Purified water; water of a defined quality meeting specifications set out in a compendia; less pure than WFI. Commonly used for oral drugs.
pyrogen Any fever-inducing (pyrogenic) substance; more specifically, a lipopolysaccharide (the major constituents of the cell walls
of Gram-negative bacteria). The major endogenous pyrogen in mammals is probably interleukin-1, production of which is stimulated
pyrogenic endotoxins Components of bacteria (such as lipopolysaccharides) that induce a feverish immune response in higher organisms.
Quality assurance; 1. the quality systems and processes used to control every step of pharmaceutical manufacturing to ensure that the product
meets all of its specifications and quality attributes, and that all steps were done and documented in compliance with cGMP.
2. The sole work unit that is empowered to disposition drug product and drug substance (release or reject) for use in humans;
and that provides and sustains quality systems such as document control, corrective and preventive actions, audits and oversight.
Quality control; 1. the system of testing that confirms and measures the quality of raw materials, process intermediates, final product and
environmental samples, during ongoing production as well as during start-up and validation. 2. The work unit that usually
performs testing regulated under cGMP and evaluates results against specifications, action limits, or targets, and makes technical
recommendations to QA. May be in the same department as QA in some organizations.
qualification Documenting that a piece of equipment does what it was designed to do, was installed correctly, and continues to operate within
specified parameters over time. 2. A term used during process or analytical development to describe the experi-ments that
are done prior to validation of the assay or process, that define the critical parameters and design space. 3. Analytical
instruments are qualified to ensure fitness for intended use (USP <1058>). See also DQ, IQ, OQ, PQ. This term sometimes is
used interchangeably with 'validation'.
quality The suitability of either a drug substance or drug product for its intended use. This term includes such attributes as the
identity, strength, and purity (from ICH Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances
and New Drug Products: Chemical Substances). [ICH Q8]
quality by design A term defined by the ICH documents, meaning the use of science, engineering, and statistical tools, as appropriate, to design
quality in to a process or product, or device; and to 'mistake-proof' or design out common errors.
quality risk management A systematic process for the assessment, control, communication and review of risks to the quality of the drug (medicinal)
product across the product lifecycle [from ICH Q9].
quality system A series of processes that are linked together and controlled centrally to increase assurance of product or manufacturing
process quality. Term used by FDA, ICH, and ISO, to define those systems that are created and maintained by QA to support
GMP operations. Examples include documentation, facility, equipment, packaging and labeling.
radiolabeled Covalently labeled with a radioactive isotope or substance.