Retest Period Log for Raw Materials / Components
1.0 Purpose: This SOP describes the time period required for retesting or re-examination of the approved raw materials.
2.0 Scope: This SOP applies to all the raw materials i.e. active and inactive which are used in the manufacture of drug formulations.
3.0 Responsibility: Quality Control Chemists to ensure that the procedure is followed.
4.0 Materials and Equipment: As required.
5.0 Procedure:
5.1 The release of raw materials for use in drug formulations can not be for an indefinite time. During storage, degradation may occur, moisture may be absorbed or materials may simply become unsuitable for use.
5.2 In general, materials (i.e. active and inactive) are used immediately in drug formulations or within a short period after purchase. Some of the materials may be stored for longer periods in store (i.e. one year or more than one year).
5.3 To assure a product meets applicable standards of safety, quality, identity, purity and potency at the time of use, every material bears an expiration date.
5.4 After an extended period of time in storage, a raw material is retested or reexamined.
5.5 Rationale and methodology used to establish a retest date for material include Material Safety Data Sheet (MSDS), Analytical data on raw material or analytical testing over the shelf life time period.
5.6 At the time of initial approval every material is assigned a retest date so that if stored beyond that period it should be retested or re-examined before further use.
5.7 At the end of every month, all the materials are checked to ensure the retest or re-examination of stored materials. A list is prepared for the materials for which retest or re-examination is required in the coming month.
5.8 Keep all the records and submit to Quality Assurance.
Form: Log For Retest / Re-examination
Date Checked On:
Checked By:
Following materials to be retested / re-examined in the month of ————.
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S.No. |
Name of Raw Material |
Exp. Date |
AR No. |
Initially Tested On |
Retest Date |
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