Standard operating procedure for dispensing of all the raw materials in pharmaceutical industries.
1.0 Purpose
The purpose of this SOP is to develop a standard procedure for dispensing of raw materials in pharma for the production department.
2.0 Scope
This SOP is applicable for the procedure used for dispensing of raw materials in store.
3.0 Responsibility
3.1 The Planning/production department shall generate dispensing order or manufacturing order (MO).
3.2 The Store officer is responsible for implementing this SOP.
3.3 The Store Manager is responsible for ensuring the implementation of this SOP.
3.4 Q.A. Officer QA monitors the compliance of this SOP.
4.0 Procedure
4.1 Planning/production department shall generate the manufacturing or dispensing order using ERP/SAP or manual system as per BMR.
4.2 The Dispensing order shall be signed by the initiator & QA officer for verification & sent to the raw material store for dispensing.
4.3 After receiving the dispensing order the raw material store officer shall verify the availability & release status of materials to be dispensed.
4.4 After ensuring availability of all materials the store officer shall print the dispensing material labels including the information like
- Product NameÂ
- Dispensing Order Number
- Lot Number
- Batch number
- Manufacturer Name
- Signing space for operator,store officer & QA officer
4.5 Dispensing operator shall remove the material containers as per MO and place in pre dispensing area.
4.6 Store operator shall turn the RLFA On 15 to 20 minutes before dispensing process.
4.7 Take line clearance of the dispensing booth from the store officer & QA officer as per line clearance SOP.
4.8 Line card is awarded after ensuring cleaning, differential pressure, temperature & humidity of the dispensing area & booth.
4.9 All the dispensing staff shall wear the secondary gowning before starting the weighing activity.
4.10 Weighing shall be done on calibrated weighing balance under RLFA
4.11 Dispensing shall be done in following order
Dispense excipients first
then dispense fluffy materials like aerosil and later on dispense colors.Perform cleaning & then dispense APIs.
4.12 Weighing shall be done by dispensing operator as per MO, weight shall be checked by store officer & cross checked by the QA officer.
4.13 Bring a material container inside the dispensing booth,scan its bar code & identification is verified by both the store and QA officer.
4.14 Take a polythene bag,check tare weight of polythene bag, dispensing label & tie clip & mention it on the dispensing label.
4.15 Open the material container under RLFA and add material from the container into the polythene bag with the help of a cleaned SS scoop.
4.16 Net weight value shall be according to the MO & mention the gross weight in dispensing label.
4.17 Lift the polythene bag, cross check the gross weight and sign the dispensing label by the dispensing operator,store & QA officer.
4.18 Close the polythene bag with a tie clip & affix the dispensing label & place it in a container already having a label of dispensed material.
4.19 close the container from which material is dispensed & send it back to its original location.
4.20 Weight all the materials one by one in the same way and at the end of dispensing all the dispensed materials shall be transferred to the post dispensing area.
4.21 Clean the scoop & dispensing area as per cleaning SOP & record the activity in the log book.
5.0 Abbreviations
5.1 SOP: Standard Operating Procedure
5.2 MO: Manufacturing Order
5.3 QA: Quality Assurance
5.4 RLAF: Reverse Laminar Air Flow