Biomedical Engineering Reference
In-Depth Information
SOP No. QCS-017.00 Effective date: mm/dd/yyyy
Approved by:
17.9 attachment form
ABC Pharmaceutical Company
SOP No.:
Issued on:
Attachment I
Revision No.:
Initiator name:
ANALYTICAL METHODS TRANSFER
Page 1 of 3
VALIDATION FINAL REPORT
Validation type: Finished product
∙
Raw materials
∙
Assay
∙
Assay
∙
Impurities
∙
Residual solvents
∙
Organic volatile impurities
∙
Product/Raw material name:
Lot #
Product codes:
Drug product concentration:
Raw material concentration:
1.0
Assay design key parameters
1.1
See attached method validation report
#
1.2
See attached governing method SOP
#
2.0
Assay method key data section
2.1
System suitability
Parameter
Limits
Results
Comments
RSD of replicate injection
Tailing factor
Resolution
2.3
Data referenced location
Laboratory notebook #
Pages
Storage location:
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