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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 (QC)

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.

Quality planning

Part of quality management focused on setting quality objectives and specifying

necessary operational processes and related resources to fulfil the quality objectives.

Quality policy

Overall intentions and direction of an organization related to quality as formally

expressed by senior management.

Quality risk management (QRM)

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.

Receiving unit (RU)

The involved disciplines at an organization where a designated product, process or

method is expected to be transferred.

Sending unit (SU)

The involved disciplines at an organization from where a designated product, process

or method is expected to be transferred.

Spiking

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.

Technology transfer report

A documented summary of a specific technology transfer project listing procedures,

acceptance criteria, results achieved and conclusions. Any deviation should be

discussed and justified.

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