CHALICE VITALCHEM PRIVATE LIMITED

Format No.: QAS003/F/03/00 Reference SOP No.: SOP/QA/003/00

Market Complaint Investigation Form
Effective Date: Page 1 of 5

Complaint No.
Date of complaint Received: ______________
(To be filled by QA)
Complaint Product Details: Name and Address of Complainant:
Product Name:
Batch No.:
Mfg./Exp.:

Name of Party: Acknowledgement sent on:

Complaint Samples Received: Yes  No  If yes: Qty. of samples received:

Nature of Complaint: Product Defect  Packaging Defects 

Adverse Drug Reaction  Other  -specify

Type of complaint: Critical  Major  Minor 

Brief Description of Complaint:

Is such type of complaint received before for the same product batch Yes  No
Is Investigation Require Yes  No  , if No, explain reason

Inspection of complaint sample:

Inspection of control sample:

Inspection of stock of same product batch or other batches available at site for defects as described in
 CHALICE VITALCHEM PRIVATE LIMITED

Format No.: QAS003/F/03/00 Reference SOP No.: SOP/QA/003/00

Market Complaint Investigation Form
Effective Date: Page 2 of 5

complaint:

Review of batch records:

Review if materials used in manufacturing/packaging of complaint batch received from approved vendor
(if applicable):

Review of analysis records (Packaging Materials /Raw Materials/Bulk Materials/Finished Products

(if applicable):

Review of change part [die/punch kit/ packaging change parts/other__________________] (if applicable):
 CHALICE VITALCHEM PRIVATE LIMITED

Format No.: QAS003/F/03/00 Reference SOP No.: SOP/QA/003/00

Market Complaint Investigation Form
Effective Date: Page 3 of 5

Review if any deviation, non-conformance, on-line rejections reported during manufacturing/packaging of

complaint batch:

Review of stability records, product quality review (if applicable):

Review of analysis of complaint sample and control samples (if applicable)::

Review if similar type of complaint received for same product or other product and corrective and
preventive action taken:

Root cause of complaint:

CAPA required (Yes/No):

If yes, fill CAPA form and attach the complaint report:

CAPA No.:_________________

Comment of Packaging/ Production Head:

(Attach Separate Sheet if Required)
 CHALICE VITALCHEM PRIVATE LIMITED

Format No.: QAS003/F/03/00 Reference SOP No.: SOP/QA/003/00

Market Complaint Investigation Form
Effective Date: Page 4 of 5

Sign/Date

Comment of QC Head:
(Attach Separate Sheet if Required)

Sign/Date

Comment of Other Dept.:

(Attach Separate Sheet if Required)

Sign/Date
Comment of Plant Head:
(Attach Separate Sheet if Required)

Sign/Date

Final Conclusion – (QA Dept.)

(Attach Separate Sheet if Required)
 CHALICE VITALCHEM PRIVATE LIMITED

Format No.: QAS003/F/03/00 Reference SOP No.: SOP/QA/003/00

Market Complaint Investigation Form
Effective Date: Page 5 of 5

Sign/Date

Corrective and Preventive Actions Taken:

Documents attached to the Report:

1. Corrective and Preventive Action Form
2. Other
Corrective Actions completed on: QA Head (Sign/Date):

Preventive Actions completed on: QA Head (Sign/Date):

Final Report Sent to Party on : QA Head (Sign/Date):

Complaint Closed on : QA Head (Sign/Date):