SOP For In-Process Checks for Dispensing of Raw Material

SOP For inprocess check for dispensing of raw material is described in this post which you can follow in the section of the Quality Assurance Department.

OBJECTIVE

This procedure has been established to provide guidelines to the Q.A. staff for the checks to be performed to ensure that dispensing process is carried out smoothly, efficiently and as per cGMP requirements.

SCOPE

This SOP will apply on the personnel from Quality Assurance, Production & Warehouse Department involved in dispensing process. 

RESPONSIBILITY

Dispensing Pharmacist, Q.A. Officer, and Production Officer supervising the dispensing activities will be responsible for the implementation of this procedure.

ACCOUNTABILITY

Manager Quality Assurance 

PROCEDURE

Dispensing must be carried out under the supervision of QAI, Dispensing Pharmacist & Production Officer.   

Check the cleaning status of area and calibration record of weighing balance and Hygrometer.

Ensure the required RH & Temperature specified for the product to be dispensed and note on the log Sheet.

Ensure the presence of relevant material as specified in the M.O, bearing identification label containing 

GRN No, lot No, mfg. date and exp. date (if applicable).

Check the approved label pasted on container duly singed by analyst and QCM.

Ensure the marking of polythene bags with the item name & batch no. to be put in as per M.O.

Ensure that dispensing equipment's (weighing balance / scale, scoops & spatula etc.) are properly Cleaned & dried.

Carefully check the identification label on the container as per M.O. to avoid any chance of error. 

Ensure all personnel involved in dispensing of material wear masks. The warehouse 

Worker weighing the material will wear gloves as well as mask.

Ensure that M.O. is signed by the checked & approval authorities.

Ensure that person supervising the process sign the M.O. to endorse the correct dispensed weights.

Ensure that polythene bags or containers of the dispensed materials are properly sealed, closed & labeled.

Ensure that polythene bags or  containers of the material are properly sealed and closed after Dispensing.

Ensure that dispensed material is immediately taken away to the Production area for manufacturing.