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Reference: WHO Technical Report Series, No. 902
Apply to: starting materials, pharmaceutical substances, excipients and medicinal products.
MODEL (template)
Registration information
Registration number of sample or certificate:
Name and address of laboratory testing the sample:
Sample information
Name of product (INN, brand name(s), etc.):
Dosage form (if applicable):
Marketing authorization number (if applicable):
Description (appearance of container and contents):
Batch number(s):
Required storage conditions:
Date received: Date of manufacture:
Expiry date (for medicinal products) or retest date (for starting materials or excipients):
Name and address of original manufacturer:
Telephone: Fax:
Test procedure Result Acceptance criteria (limits)
xxx xxx xxx
xxx xxx xxx
A. Tests performed on samples from batch for which certificate is issued
B. Tests performed as part of periodicstatistically based testing programme
Conclusions:
Compliance with acceptance criteria: yes no
Date test performed/finalized:
Name and address of head of laboratory/authorized person:
Telephone: Fax:
Signature:
Explanatory notes
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