Procedure For Annual Product Quality Review

Procedure For Annual Product Quality Review

STANDARD OPERATING PROCEDURE
Title : Procedure For Annual Product Quality Review
  • OBJECTIVE
  •    To lay down a procedure for Annual Product Quality Review.
  • SCOPE
    • This procedure is applicable to Quality Assurance Department for annual product review of finished products .
  • RESPONSIBILITY
    • Executive-Quality Assurance
  • ACCOUNTABILITY
    • Manager-Quality Assurance
    • VP – Plant & Operations
  • PROCEDURE
    • Annual Product Quality Review shall be carried out for each product manufactured in the previous year. Along with Annual product review, implementation of preceding year’s recommendations should be reviewed.
    • For similar products with different brand names in formulation shall be grouped / clubbed for Annual product review.
    • Annual Product Quality Review report should be completed by the month of February.
    • Annual Product Quality Review shall essentially include the assessment of product history by involving the following attributes:-
      • Trend analysis of essentially the following parameters shall be compiled product wise and batch wise.
      • Assay, Disintegration test, Friability, Hardness, Water content, Uniformity of weight.
      • Review of all batches that failed to meet established specifications and related investigation.
      • A review of all deviations or non-conformances and related investigation.
      • Review of any changes carried out to the processes, system or analytical methods.
      • Product Recall, reason for Recalls and corrective actions taken / planned.
      • Returned Goods and Salvaged Goods.
      • Control sample review and observations.
      • Out of specifications.
      • Market Complaints, investigations and the corrective actions.
    • Based on Annual Product Quality Review, recommendation should be made in the report for any desired changes.
    • Annual Product Quality Review shall be prepared by Quality Assurance as per the format no. 1.
    • Annual Product Quality Review shall be checked by Executive-QA.
    • Manager – Quality Assurance shall approve Annual Product Review.
    • Shall Authorized Annual Product Review?
    • All record shall be archived in Quality Assurance.
  • ABBREVIATIONS
    • QA –  Quality Assurance
    • SOP –  Standard Operating Procedure
  • ATTACHMENT  
Sr. No. Title  Format No.
1. Format for annual product quality review          1

 

  • DISTRIBUTION LIST
Sr. No. Copy No. Department
Quality Assurance
Quality Control
Plant & Operations

 

ATTACHMENT  -I

annual product Quality review

Name of the Product  :

Generic Name            :

Department 

Quality Assurance

Session

YYYY

  •  List of batches manufactured 
  • Trend analysis of quality parameter
  • Deviations reported in the year
  • Control sample observation
  • Product recall
  • Out of specification
  • Batch failures
  • Market complaints
  • Change in process
  • Abbreviations

 

NORFLOXACIN & LOPERAMIDE CAPSULE

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