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CoA template

已有 358 次阅读2022-11-29 14:04 | GMP, COA, 模板

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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回复 halfmoon 2022-11-30 11:03
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