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