Bulk Hold Time Study

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PURPOSE: To provide a system for establishment of the holding period for the bulk product during manufacturing process under the relevant storage condition.

SCOPE: This procedure is applicable for the hold time study of bulk product manufactured at X-Pharma.

        REFERENCES: In-house

         RESPONSIBILITIES: 

            Quality Assurance: To ensure the implementation of SOP.

            Production:
  Ø  To coordinate with the hold time study per procedure.
  Ø  To maintain the record.

           Quality Control: Analyses the sample as per procedure.
      
     DISTRIBUTION:

  Ø  Quality Assurance
  Ø  Production
  Ø  Quality Control

     DEFINITIONS AND ABBREVIATIONS: 

     HEALTH, SAFETY, AND ENVIRONMENT: 

    PROCEDURE:

  Ø  The frequency for the bulk holding time study will be 4 weeks and 6 weeks or on the basis of fixed period.
  Ø  The bulk holding time studies will be carried out on scale up /commercial batch.
  Ø  The study will be carried at bulk stage i.e. compressed tablets, bulk solution, bulk ointment.
  Ø  The bulk samples will be drawn from each stage separately if more than one stages sample needs to undergo the test.
  Ø  This sampling and testing plan for bulk holding time study is described in the sampling and testing part of individual product protocol.
  Ø  Bulk holding time study results will be used to propose the maximum holding period of the intermediate product for commercial batches.
  Ø  The data received from the holding time study will be compiled, summarized in holding time summary report and evaluated to establish the maximum storage period under relevant storage condition for the each manufacturing stage of the product.

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