Monday, June 17, 2013

What is pharmaceutical sampling, documents & records?

1.      What is sampling? What standards are used for sampling?
Sampling: The taken of samples or sample, which represent the whole batch or lot.

Sampling should be conducted according to written procedures. Sampling Process are obtain from finished material, in-process material, raw material or components for assessment with a view to determining the properties of the universe from which they were drawn.
Sampling plan -
Specific design indicating number from each lot or batch are inspected & determined the acceptability the lot or batch. Military Standard 105E is frequently used for determining statistical sample size.

2.      Write the differences  between documents  & records.

 Documents : Documentation is a controlled written procedure, policy, forms or other pieces of paper as defines a company requirement. & describe how what to do.

Records :  When data or results providing evidence of activities performed then it is record.

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