Product Quality Investigations - Quality Procedure

Standard Operating Procedure

Product Quality Investigations

(Quality)

Version No.:                                    

Effective Date:                                

Review Date:                                  

Supersedes:                       

Author(s):                            

	Technical Approver	Authorized By
Name
Designation	Head of Department / DI	Director / DI	QA
Signature
Date

1.            Purpose

This procedure details the requirements for conducting and documenting a product quality investigation (PQI).

2.            Scope

This SOP is to be followed when a potential quality critical issue (i.e., problem that can potentially affect the quality, safety or efficacy of a product) has been identified and which is not investigated in accordance with an existing procedure (like, Deviations, Calibration failures, Vendor failures etc).

Examples of these issues include:

·         Label mix up,

·         Presence of foreign tablets in a container,

·         Defects in product/ packaging and labelling,

·         Determination of true product failure,

·         Non compliant documentation

·         Non assignable cause for out of specification

This also includes investigations on comparator products used in a study.

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