Saturday, November 20, 2010

Released Of Finished Products

1.0     Purpose  :         To provide instruction for released of finished products.

2.0    Objective :      To provide a documented procedure for released of finished products.

3.0       Scope  :            This procedure is applicable for released of finished products.

4.0      Responsibility  :
·        Primary: Officer – QA / Officer-Store
·        Secondary: Officer – QA Manager.

5.0          Procedure :
·        On completion of Batch Manufacturing activity, Batch Manufacturing Record will be handed over to QA personnel by production personnel with all attachments. 
·        Review the Batch Manufacturing Record by checking the following points:
Ø       Product Name
Ø       Batch Number
Ø       Manufacturing Date
Ø       Expiry Date
Ø       Manufacturing License Number
Ø       Raw Material requisition and issue details
Ø       Filled contents and their legibility
Ø       Cleaning record at all stages of manufacturing
Ø       Test requests issued to QC
Ø       QC release against issued test requests
Ø       IPQC & IPQA reports
Ø       Environment control & results of water used in manufacturing process.
Ø       Packing material details
Ø       Balance calibration record
Ø       Weighing record
Ø       Final product certificate of analysis
Ø       Yield reconciliation
Ø       Deviations (or any other discrepancies) and its Justification
Ø       Reconciliation and yields
Ø       Signature of all Authorized persons.
·        If all the above points are satisfied, fill the history sheet of the batch manufacturing record.
·        Enter the observation of above points in to the batch manufacturing record.
·        Reviews the QC reports by checking the following points:
Ø       Product Name
Ø       Batch Number
Ø       Manufacturing Dated
Ø       Expiry Date
Ø       Pack size
Ø       Compliance of test results
Ø       Calculation in work-sheets
Ø       System related data sheets like graphs/ chromatograms etc.
Ø       Signature of all authorized persons.
·        QA personnel places all reports related to one batch together like, Batch Manufacturing record, COA and worksheet in a folder
·        When intimation comes from stores to dispatch the goods, QA personnel must confirm that the demanded finished goods, meets the requirement of order.
·        If finished goods meet the requirements, QA personnel inform to store department for dispatching the material.

6.0    Reference Document  :   Not applicable

7.0     Abbreviations  :
·        QA   = Quality Assurance department
·        SOP = Standard Operating Procedure
·        QC = Quality Control

8.0   Copies to  Distribution Sites :
·        QA
·        QC 

1 comment:

  1. is there warehousing activity procedure available? or handling procedure for finished products? thank you..


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