ANALYTICAL WORK SHEET AND COA PREPARATION

• OBJECTIVE:

• To lay down a procedure for analytical work sheet and COA preparation.

• SCOPE:

This SOP is applicable to the procedure for analytical work sheet and COA preparation at {Company Name} {Location}.

• RESPONSIBILITY:
• Officer/Executive/Designee Quality Control – Shall be responsible for operation as per SOP.
• Head/Designee Quality Control – Shall be responsible for ensuring compliance as per SOP.
• QA Executive/Designee – Issuance and retrieval of work sheets.
• ACCOUNTABILITY:

             QA Head shall be Accountable for implementation of SOP.

• PROCEDURE:
  • The following procedure shall be considered for preparation & issuance of work sheet and COA:
    • All worksheets shall be prepared as per STP’s with accuracy and correctness of data for the tests and the approved worksheets shall be issued to QC.
    • All the work sheets shall be issued by QA personnel.
    • All the worksheets shall be issued to QC by QA stamp and sign with date.
    • All COA’s shall be prepared as per specification with accuracy and correctness of data for the tests, respectively for Finished product and Raw material.
    • QC shall fill requisition of analytical work sheet issuance.

Note: Only Approved Worksheets shall be issued.

• REFERENCES:

Not Applicable

• ANNEXURES: 

ANNEXURE NO.	TITLE OF ANNEXURE
Annexure-I	Analytical Work Sheet
Annexure-II	COA of Raw material
Annexure-III	Issue request for analytical work sheet
Annexure-IV	Worksheet issuance and retrieval register
Annexure-V	COA of finished product

         ENCLOSURES: SOP Training Record.

•  DISTRIBUTION:
• Controlled Copy No. 01  :          Head Quality Assurance
• Controlled Copy No. 02  :         Head Quality Control
• Master Copy                    :          Quality Assurance Department

• ABBREVIATIONS:

No.	:	Number
SOP	:	Standard Operating Procedure
COA	:	Certificate of analysis
STP	:	Standard test procedures
QC	:	Quality Control

• REVISION HISTORY:             

CHANGE HISTORY LOG

Revision No.	Details of Changes	Reason for Change	Effective Date
00	New SOP	Not Applicable	To Be Written Manual

Annexure-I
Analytical Work sheet
WORK SHEET

Annexure-II
COA for Raw material

Annexure-III
ISSUE REQUEST FOR ANALYTICAL WORK SHEET

Annexure-IV
WORKSHEET ISSUANCE AND RETRIEVAL REGISTER

Annexure-V

CERTIFICATE OF ANALYSIS OF FINISHED PRODUCT