To lay down a procedure for storage & transfer of dispensed raw material in day store-I.
This SOP shall be applicable for all dispensed raw material in day store-I of all products to be manufactured in shop floor.
3.1 Execution : Operator
3.2 Checking : Production Pharmacist & Above
HOD-Production / Assigned Designee
5.1 The material to be dispensed as per the manual calculation & system generated
SAP pre-dispensing sheet
duly signed & Checked by
Q.A. person, production person & store person.
5.2 The full batch once dispensed in dispensing area should be transferred to the day store through pass box to the shop floor production person ,which will cross verified the dispensed material as per the dispensing labels.
5.3 Once verified, the shop floor production person has to prepare & affix the under process status label as per SOP on the containers/carets by writing full information like no. of containers, the dispensed raw material, ready for granulation, Batch No, Batch size, Mfg. Date, Exp. Date, sign & Date etc.
5.4 Segregate properly all the dispensed raw materials on the basis of caret no. on the under process labels to avoid the batch mixing in day store I & mention the same in the day store I Log .
5.5 When the dispensed material to be taken to the shop floor for manufacturing, the production person has to cross verified all the dispensed material weights as per the dispensing slips, once satisfied then entering the same in the Day store I log to carry forward the process.
• The Day store I should be always in lock & key.
• The dispensed raw material should be stored in day store I up to 15 days then it should be again verified for the weight.
• Empty Hard Gelatin Capsules to be dispensed just prior to the filling.
• If the
API material is sensitive in
the Storage conditions then it should on priority after dispensing and follow
all necessary storage instructions.
• Once the carets get empty from the dispensed raw material, it will be immediately sent for cleaning to the washing area.
• Weights to be checked on the calibrated balance only.
6.1 SOP: Standard Operating Procedure
6.2 Q.A.: Quality Assurance
6.3 HOD: Head of The 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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