QualityGuidances

• Objective:

To lay down a standard procedure for preparation of certificate of analysis.

• Scope:

This SOP is applicable for preparation of certificate of analysis in Quality Control Department

• Responsibility:

Officers/ Executive – Quality Control shall be responsible for follow the procedure mentioned in this SOP.

• Accountability:

Head QC and Head QA shall be accountable for compliance of this SOP.

• Attachment:

 Raw Material Certificate of Analysis                                                      Attachment-I

Bulk Product Certificate of Analysis                                                      Attachment-II

Intermediate Product Certificate of Analysis (uncoated)                 Attachment-III

Intermediate Product Certificate of Analysis

(Coated, Filled Capsules, Syrup, Sachet)                                              Attachment-IV

Finished Product Certificate of Analysis                                              Attachment-V

Packing Material Certificate of Analysis                                              Attachment-VI

Water Sample Certificate of Analysis                                             Attachment-VII

• Procedure:
  • After completion of analysis, Officer Quality Control shall prepare the Certificate of analysis as per respective specification of the products and material.
  • COA of Raw Material, Bulk, Intermediate (uncoated), Intermediate (Coated, Filled Capsules, Syrup, Sachet) and Finished Product shall be prepared as per Attachment-I, II, III, IV, V.
  • COA of Packing Material and Water Sample shall be prepared as per Attachment –VI, VII.
  • Working Standard COA shall be prepared as per of SOP/QC/009.
  • COA for all the materials and products along with their worksheet shall be reviewed by Executive – Quality Control and send to Head QC for final review and approval.
  • COA for all the materials and products shall be prepared on company letter head.
  • Two copies of COA for Finished Product shall be prepared. One shall be sent with consignment, second one shall be sent to QA and photocopy of COA shall be enclosed with raw data.
  • Two copies of COA for Bulk, Intermediate (Uncoated), Intermediated (Coated, Filled Capsules, Syrup, Sachet), Packing Material and Water sample shall be prepared. One shall be sent to QA second one shall be enclosed with raw data.
  • Photocopy of raw material COA shall be sent to warehouse along with intimation Slip.
• References:

In house

• Abbreviations:

             QC: Quality Control

QA: Quality Assurance

COA: Certificate of Analysis

• Distribution list:

Quality Control

Quality Assurance

• HISTORY OF REVISION:

Version Number	Effective Date	Reason for Revision