sop for Retesting and resampling of raw materials

 

1.0 OBJECTIVE   

To lay down a procedure for Retesting and Re sampling of Raw materials lying in warehouse for Longer period.

2. RESPONSIBILITY

Chemist / Executive

3. ACCOUNTABILITY

Manager Q.C

4. PROCEDURE

4.1 Re sampling of a material will be done as and when the retest period is due. ( Annexure I )

4.2 Material shall be transferred to Quarantine area as soon as retesting period in due and affixed with ‘Quarantine ‘ label. The Quantity under retesting shall be deleted from the approved stock.

4.3 An intimation for re sampling shall be sent to Quality control department.

4.4 QC chemist will sample the material as per SOP in case of non- sterile material and as per SOP in case of sterile material

4.5 In case of retesting, sample the material from the containers equal to  ( where n is the total number of containers under retesting )

irrespective whether the drug is active or inactive.

4.6 All the raw materials shall be retested ONLY TWICE during their shelf life.

4.7 Resampled material shall be tested for specified critical parameters like Assay, Moisture, Impurities, pH , etc and if found satisfactory the material will be re approved with new Analytical Report Number for future follow up.

5.0 ABBREVATIONS :

SOP : Standard Operating Procedure

6.0 ANNEXURES : Annexure I

 

ANNEXURE I

S.NO.	RAW MATERIALS	RETEST PERIOD
A	VITAMINS EXCEPT CHOLECALCIFERROL (VIT D3).	12 MONTHS.
B	CHOLECALCIFEROL ( VIT D3).	6 MONTHS
C.	ANTIBIOTICS /  ANTIBACTERIALS.	12 MONTHS
D	STERILE  RAW MATERIALS.	6 MONTHS
E	ALL EXCIPIENTS  ( EXCEPT FLAVOURS ).	24 MONTHS
F	ALL FLAVOURS .	12 MONTHS
G	ALL OTHER ACTIVE INGREDIENTS.	12 MONTHS
H	ENZYMES	6 MONTHS