SOP for Retesting Schedule of Raw Material (For API) : Pharmaceutical Guidelines

SOP for Retesting Schedule of Raw Material (For API)

Standard operating procedure to prepare the retesting schedule for Raw Material.

1.0 OBJECTIVE

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

2.0 SCOPE

This procedure is applicable for retesting of approved raw material which is stored in the raw material store.

3.0 RESPONSIBILITY

3.1 Doing: Technical Assistant
3.2 Checking: Executive/ Manager

4.0 ACCOUNTABILITY

Head of the Department

5.0 PROCEDURE

5.1 On receipt of raw material, enter retesting date on MRR and on all approved label.
5.2 Retest due date shall not be more than the expiry date of the raw material.
5.3 Give two years retest due date for all materials from the date of sampling.
5.1 For the material having lower expiry date than 2 years retest period, assign the retest date for 1 year in that case.
5.5 Receive the information from stores one month in advance for the material due for retesting.
5.6 Sample the material for retesting as per √n+1 formula as per the list received from stores Dept and verify against previous records.
5.7 Put the sampled stamp on the drums selected for sampling.
5.8 Affix Retest label on each container.
5.9 Carry out the following test for each raw material.
Description
L.O.D/Water content
Chromatographic purity or similar purity test
Assay
pH, Acidity/Alkalinity

6.0 Prepare a test report after analysis if it conforms to specification assign a new retest due date on the approved label.
6.1 If the material fails, initiate the disposition of the material after due scrutiny by concerned authorities.
Related: SOP for Collection and Storage of Retained Samples of Raw Material

6.2 ABBREVIATION

6.1 L.O.D = Loss on drying
6.2 Q.C. = Quality Control
6.3 GRN = Good Receipt note
6.4 Dept = Department





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.
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