MAVERICKS ASSOCIATION

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SOP

SOP ON HANDLING AND MANAGEMENT OF PRODUCT COMPLAINT

Original price was: ₹300.00.Current price is: ₹200.00.

  PURPOSE To define a procedure for handling market complaints. SCOPE This SOP shall be applicable to all the market complaints of drug products received directly or from any other source. REFERENCE(S) & ATTACHMENT(S) REFERENCE(S) In House CROSS REFERENCE DOCUMENTS Document(s) and Data Control Procedure. Change Control Management. Corrective and Preventive Action (CAPA). Quality Risk Management (QRM). SOP on Investigations. Handling, Management and investigation of Deviation. Good Document Practice (GDP). DEFINITIONS Complaint: A market / consumer complaint is notification that a product in commercial distribution (which also includes physician sample). May be in violation of the laws or regulations administered…

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PREMADE DOCUMENTS IN MICROSOFT SOFT WORD COPY

SOP ON HANDLING AND MANAGEMENT OF PRODUCT COMPLAINT WITH ATTACHMENTS

Attachment-I: Flow Chart for the handling of Market complaints.

Attachment II: Format of market complaint log at the manufacturing location.

Attachment-III: Format of Market Complaint Preliminary Investigation Report (PIR).

Attachment-IV: Examples of market complaints-guideline for investigation

Attachment-V: Format of Market Complaint Final Investigation Report (FIR).

Attachment-VI: Classification of market complaints

Attachment-VII: ADR Reporting Form

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