quality control 2 lec

quality control 2 lec

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  • guidelines are primarily intended for use by governmental organizations such as drug regulatory authorities, quality control lab. but some of the general principles may also be appropriate for application by procurement agencies,manufacturers and customers.
  • Introduction
  • Guidelines for Sampling of pharmaceutical products and related materials
  • guidelines should be useful when surveying the national markets for the quality of drug products
  • and the choice of sampling plan should always take into consideration the specific objectives of the sampling and the risks, consequences associated with inherent decision errors
  • Sampling procedure should be appropriate to the purpose of sampling, to the type of controls intended to be applied to the samples and to the material to be sampled.
  • Sampling comprises the operations designed to select a portion of a pharmaceutical product for a defined purpose
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