Friday, May 8, 2009

Raw Material Issuance

1.Purpose
This standard operating procedure outlines the method for the dispensing and issuance of approved raw material requested for processing by the production department on relevant manufacturing orders.

2.Responsibility
Store Incharge
Store Officer
Production Officer
Quality Control Officer
3.Procedure
Before commencing the dispensing, check that:
Dispensing area is clean.
Dispensing table is clean.
No raw materials of the previous weighing are lying in the dispensing area.
The weighing balance is clean and calibrated. (The calibration should be properly recorded on the weighing balance calibration sheet attached to the balance).
The weighing accessories i.e. scoops spatulas are properly cleaned.
The protective garments i.e. gloves and face masks are available and the personnel engaged in dispensing and checking is wearing them.
The rubber gloves are provided for the dispensing of potent drugs.
The required relative humidity is present and a daily record is being maintained.
Only one raw material is brought at one time for dispensing.
The spillages are removed at once and the exhaust system is properly working.

The bin cards should be properly maintained for all raw materials and FIFO policy should not be disturbed at any time.
The dispensing should be done by the warehouse officer or his designate for proper and accurate a cross check system of the weighing / dispensed materials is made and recorded.
The dispensing should only be done after thorough checking of the manufacturing order for the Product’s name, Code No., M.O. No., Batch Size and Date.
The dispensing of any raw material should not be made prior to checking the condition of container; the Q.C. released label and revalidation date as well as the properly maintained ware house label or tag. Every container must be released like original after dispensing.
The raw materials must be weighing very carefully on a balance of appropriate accuracy in appropriate containers after checking their tare weights.
Each raw material must be checked for its physical appearance order and presence of any foreign substance or particles. If the appearance is doubtful or it contains extraneous material or particles it should not be issued for processing but should be immediately quarantined and referred to the Quality Control Department for re-checking.
The raw material must be issued against the Lot No. or A. No. any material of two different lots should be weighing separately and issued in separate should area be recorded on the manufacturing order.
After completing the dispensing of every individual item the issued Qty. a Lot No., weighing by and checked by columns of the manufactured order must be properly initialed.
All raw materials issued against any manufacturing order must be kept separately in an area un-accessible to the unauthorized personal or under lock and key.