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There must be sufficient qualified personnel to carry out all the tasks which are the responsibility of the manufacturer
The definitions and interpretations of terms in section 201 of the Federal Food
properly storing and disposing of equipment and trash
in an unopened state
with clearly defined areas to prevent mix-ups or contamination with microorganisms
10.8 - Laboratory Method Validation labellling There must be sufficient qualifiedYou must verify that the laboratory examination and test methods are appropriate for their intended use for each supplement or drug. You must identify and use an appropriate scientifically valid method for each established specification for which testing or examination is required. Non pharmacopeial, in house methods must be validated, see ICH Q2(R2)
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