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SOP for Retesting Schedule of Raw Material

Standard operating procedure to prepare the schedule for retesting of the approved active and inactive Raw Material.


       To ensure compliance of approved raw material at regular interval of storage.

2.0  SCOPE

       This procedure is applicable for approved active and inactive raw material which are stored in the raw material store.

3.0  RESPONSIBILITY         

3.1  Doing      : Technical Assistant
3.2  Checking : Executive /Manager


       Head of the Department


5.1  On receipt of raw material, enter the retesting date in MRR and in the computer system on basis of list prepared and updated as per annexure I and II for active and inactive raw material respectively.
5.2  Retest due date shall not be more than expiry date of raw material. If expiry date is less then assign the retest date of 1 year or half the period as stated in annexure I & II whichever is less for that particular material.
5.3  Receive the information from store one month in advance for the material due for retesting.
5.4  Sample the material for retesting as per schedule as per the list received from raw material store and verify against their records.
5.5  Affix "UNDER RETEST" label on each container and cross out ‘Approved ’ label with marker on all the containers.
5.6  Change the status of material in the computer from Approved to under test if materials are not sampled & tested before the due date of retest.
5.7  The color of “UNDER RETEST” label is blue and enter the following details in the label.
Name of  Material
A.R. No.
Sampled  By
:                                              Date :
5.8  Mark ‘SAMPLED’ stamp on containers from which the samples are collected.
5.9  Carry out the following test for each raw material as applicable.
           1. Description
           2. L.O.D/Water content
           3. Chromatographic purity/Related substances
           4. Assay
           5. Microbial limit test
           6. pH / Acidity / Alkalinity test
           7. Bacterial Endotoxin test
5.10  On approval, affix “APPROVED” label with new retesting date on all the containers.
5.11  Give the new resting date as per the list of Annexure I & II considering the previous retesting due date as initial date.
5.12  If material is rejected affix “REJECTED” label on each container.
5.12  Change the status of the Material in computer from under test to Approved / Rejected if status is change to under test as per point 5.6.
5.14  Prepare retest report, check and get it signed by quality control incharge.
5.15  Keep the record of retesting in separate file.

Related: SOP for Retesting of Raw Materials


6.1  L.O.D = Loss on drying   
6.2  MRR = Material receipt report
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
Email: .moc.enilediugamrahp@ofni Need Help: Ask Question

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