Quality assurance is a wide-ranging concept covering all matters that individually or
collectively influence the quality of a product. It is the totality of the arrangements
made with the objective of ensuring that pharmaceutical products are of the quality
required for their intended use.
Quality control covers all measures taken, including the setting of specifications,
sampling, testing and analytical clearance, to ensure that starting materials,
intermediates, packaging materials and finished pharmaceutical products conform
with established specifications for identity, strength, purity and other characteristics.
Part of quality management focused on setting quality objectives and specifying
necessary operational processes and related resources to fulfil the quality objectives.
Overall intentions and direction of an organization related to quality as formally
expressed by senior management.
Quality risk management is a systematic process for the assessment, control,
communication and review of risks to the quality of the pharmaceutical product
throughout the product life-cycle.
The involved disciplines at an organization where a designated product, process or
method is expected to be transferred.
The involved disciplines at an organization from where a designated product, process
or method is expected to be transferred.
The addition of a known amount of a compound to a standard, sample or placebo,
typically for the purpose of confirming the performance of an analytical procedure.
Standard operating procedure (SOP)
An authorized written procedure giving instructions for performing operations not
necessarily specific to a given product or material (e.g. equipment operation,
maintenance and cleaning, validation, cleaning of premises and environmental control,
sampling and inspection). Certain SOPs may be used to supplement product-specific
master and batch production documentation.
A documented summary of a specific technology transfer project listing procedures,
acceptance criteria, results achieved and conclusions. Any deviation should be
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