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DOCUMENTATION PRACTICE PRESENTED BY  HARISH DHANASHREE I.M.PHARMA  DEPT OF PHARMACEUTICS
INTRODUCTION ,[object Object],[object Object]
Drug and cosmetic rules… ,[object Object]
What documentation system consists…? ,[object Object],[object Object],[object Object],[object Object],[object Object]
Importance of Documentation ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Documentation-Important Areas ,[object Object],[object Object],[object Object],[object Object],[object Object]
MASTER FORMULA RECORDS ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Types of Master Formula Records ,[object Object],[object Object]
MASTER PRODUCTION AND CONTROL RECORDS ,[object Object],[object Object]
SEQUENCE OF 9 SUBSECTION
BATCH PRODUCTION AND CONTROL RECORDS ,[object Object],[object Object],[object Object],[object Object]
BATCH PRODUCTION AND CONTROL RECORDS ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
RAW MATERIALS ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
FORMAT Name of the material: RECEIPT ISSUE/DISPOSAL Date of receipt Invoice number & date Name   & Address of supplier Qty Recd (pack   size) B. No. Mfg date Exp date Name & Address of manufacturer Opinion Of Q.C. Dept QC Report No.&   Date Date Of Issue Qty issued Name & B. No. of product   for which issued Balance Particulars of disposal if not used Sign of issuing person
Labels and printed packaging material records ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Drug product container, closure, and labelling records . ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Drug product container, closure, and labelling records .  Name of the material: RECEIPT ISSUE /DISPOSAL Date of receipt Qty  received Invoice  No  Date, name &address  Consignment number  Opinion  of  Q.C Q.C. report  No & date Date  Of issue   Qty  issued Batch .No  for which issued balance Particulars  of disposal if not   used Sign of issuing person
QUALITY CONTROL RECORDS: ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
REFERENCE ,[object Object],[object Object],[object Object]
[object Object],[object Object]

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Mfr

  • 1. DOCUMENTATION PRACTICE PRESENTED BY HARISH DHANASHREE I.M.PHARMA DEPT OF PHARMACEUTICS
  • 2.
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  • 7.
  • 8.
  • 9.
  • 10. SEQUENCE OF 9 SUBSECTION
  • 11.
  • 12.
  • 13.
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  • 15. FORMAT Name of the material: RECEIPT ISSUE/DISPOSAL Date of receipt Invoice number & date Name & Address of supplier Qty Recd (pack size) B. No. Mfg date Exp date Name & Address of manufacturer Opinion Of Q.C. Dept QC Report No.& Date Date Of Issue Qty issued Name & B. No. of product for which issued Balance Particulars of disposal if not used Sign of issuing person
  • 16.
  • 17.
  • 18. Drug product container, closure, and labelling records . Name of the material: RECEIPT ISSUE /DISPOSAL Date of receipt Qty received Invoice No Date, name &address Consignment number Opinion of Q.C Q.C. report No & date Date Of issue Qty issued Batch .No for which issued balance Particulars of disposal if not used Sign of issuing person
  • 19.
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