Organizing Chemical and Microbiological Analysis

Organizing  Chemical and Microbiological Analysis

(Standard Operating Procedure)

(Analytical)

AP001

Version No.:                        

Effective Date:                     [j1]            

Review Date:                       [j2]            

Supersedes:                       

Author(s):     [j3]                                    

	Reviewed By[j4]		Approved By[j5]	Authorized By[j6]
Name[j7]
Signature[j8]
Date[j9]

1.            Justification

SOP No.	Supersedes No. & Date	Changes made (in brief)

2.            Purpose

This SOP describes the process of testing (receipt, storage, analysis and disposal) as well as generation of test reports for the samples received at Fem Analytika.

3.            Scope

The requirement specified in the document is applicable for carrying out all types of testing (physical, chemical and microbiological) carried out with in Analytical Sciences. The samples may be received from various cross functions. Scope of such samples may include actives, excipients, developmental samples, intermediates, and finished products. Method development and/or method verification samples need not comply with respect to generation of test report.

4.            Abbreviations / Definitions[j10] 

ARF      : Analytical request form

SIOR    : Sample inward & outward record

5.            Procedure[j11] 

5.1          Internal Analysis

5.1.1       Receiving samples

Scientist responsible should verify the information provided in ARF (Appendix 1) with respect to the samples received on receipt of the sample.

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