- To lay down a procedure for dispensing of raw materials and transfer of dispensed materials from RM stores to various sections of the Production Department.
- This Standard Operating Procedure is applicable at Raw Material Store for dispensing of Raw Materials and their transfer to the various sections of the Production Department at formulation plant.
- Raw material Store and Production personnel shall be responsible to follow the procedure mentioned in this SOP.
- Raw material Store and Production in-charge shall be responsible for implementation of the procedure mentioned in this SOP.
- Raw material Store in-charge & QA Head shall be accountable for the implementation of this SOP.
Abbreviations and Definitions
- SOP: Standard Operating Procedure; a document where step-by-step instructions are cited to serve as support for methods or manners of fulfilling a function or functions reliably and consistently.
- QA: Quality Assurance
- Ltd.: Limited
- BMR: Batch Manufacturing Record
- RM: Raw material
- RLAF: Reverse Laminar Air Flow
- R. No. : Analytical Report Number
- API : Active Pharmaceutical Ingredient
- FIFO: First In First Out
- FEFO: First Expiry First Out
- ERP: Enterprises Resource Planning
- Mfg. : Manufacturing
- Exp. : Expiry
- SS: Stainless Steel
- IPA: Isopropyl Alcohol
Pre-start up activity for dispensing & Issuance of Raw material:
- On the receipt of the requisition slip from the production department for the manufacture of a product, the store personnel shall ensure that the requisition slip bears the signature of all the concerned persons and verify the availability of “Approved Stocks” required for the concerned batch.
- After that store personnel shall generate dispensing sheet and issue a note with auto-generated A.R No. along with Batch No. of the material through ERP. The store personnel shall dispense the materials on the basis of “First Expiry First Out” (FEFO) followed by “First In First Out” (FIFO) system as per dispensing sheet and issue note.
- Before starting the dispensing, Raw Material Store & production personnel or their trained personnel shall ensure the following:
- Area and equipment are cleaned.
- Scoops, spatulas, and other utensils shall be neat and clean.
- Personnel engaged in the dispensing activity shall bear protective garments including hand gloves, masks, and where necessary safety glasses and gas masks.
- Differential Pressure, Temperature, and Relative Humidity of dispensing area are within the specified limit.
- Documents of previous products are removed from the area.
- Cleaned pallets are kept for staging the materials.
- All the logbooks of the respective areas are updated.
- Approved materials are to be dispensed.
- The RLAF is switched “ON” 15 -20 minutes before the dispensing activity starts.
- One item of a batch shall be dispensed at a time for one batch.
- The issue note shall be signed by the concerned persons before compounding the raw material.
Dispensing of Active & Inactive Raw Materials
- Production personnel shall calculate the exact quantity of API and excipient with which the API is to be adjusted according to standard batch size (if applicable), as mentioned in BMR and the same shall be verified by QA personnel.
- Take line clearance from QA personnel before starting the dispensing activity and attach it to BMR.
- After Line Clearance, Store, production & QA personnel shall supervise the weighing/measuring of the raw materials.
- Dispensing shall be done in controlled conditions, under RLAF.
- Store personnel shall bring all the required raw materials (both active and inactive) from the approved RM Store to the dispensing booth through the pass boxes.
- The dispensing of all the raw materials shall be carried out by the store personnel in the presence of the RM Store in charge, production, and QA personnel.
- All inactive ingredients shall be dispensed before active ingredients, except colors and flavors which shall be dispensed at the last.
- If the product has more than one active ingredient, then the lower potency API shall be dispensed first followed by the API with a higher potency.
- Weigh sequentially, correct quantities of raw materials in a double-lined poly bag. Twist the inner polybag, fold it in U-shape and seal it with a cable tie.
- Put the “Dispensed” label in between two poly bag & twist the outer polybag, fold it in U-shape and seal it with a cable tie.
- The “Dispensed” label which is also known as “Material Issue Slip” shall be filled with details like Mfg. Date & Exp. Date in case of API only and not required in the excipients.
- In case of light-sensitive material, switch off tube lights of dispensing booth before dispensing. Dispense the material in a black polythene bag (as the inner bag), twist, and seal it with a cable tie.
- Put this black inner poly bag in another new, transparent polybag along with the “Dispensed” label.
- Dispensing of colors and flavors shall be done only after switching “OFF” the RLAF.
- The required quantity of colors and/ or flavors shall be weighed and put in a poly bag or butter paper (whatever is appropriate as per quantity to be dispensed) and this polybag/butter paper shall be put in a new polybag along with the “Dispensed” label.
- During dispensing the persons supervising the dispensing operation shall check the following particulars regarding each dispensed material:
- Physical status of the container of the raw material.
- Name of the raw material, its batch No. and date of expiry
- R. No.
- Pharmacopoeial specification
- Entries regarding the dispensed raw materials shall be made in the dispensing sheet by the production personnel and all the entries shall be signed by the store, production, and QA personnel.
- The dispensed raw materials shall be taken out of the dispensing area through the pass box and shall be taken to the production section through the material movement corridor.
- From the material movement corridor, the dispensed materials shall be taken to the batch preparation room through a pass box.
- After dispensing, the containers from which raw material is dispensed shall be closed effectively, sealed, and labeled as “LOOSE”.
- All the liquid raw materials shall be dispensed in clean and dry SS containers.
- After dispensing the balanced raw materials shall be taken back to the approved raw material store and the dispensing booth and equipment used for dispensing shall be thoroughly clean and necessary entry shall be made in the logbook maintained for this purpose.
- Dispensing of the sterile raw materials shall be made under laminar flow in the Aseptic Area. Before taking the container into the Aseptic Area it shall be disinfected with IPA (70%) from outside (if required).
- The dispensed raw materials which are to be taken to the Aseptic Area shall be sent through a pass box to the batch manufacturing room and before placing the material in the pass box containers shall be disinfected with IPA from outside.
- In case of dispensing of hard gelatin capsules, the supply shall be made by weight in excess of the requirement for the processing of the batch of a product and the excess unused capsules shall be returned by the production section to the RM Store by weight.
- Record the dispensing activity in Sequential Equipment Logbook.
- After completion of dispensing activity, the area shall be cleaned thoroughly, and cleaning details shall be recorded in Sequential Equipment Logbook.
Issuance of additional Raw materials:
The additional raw material shall be issued to the production department under the following circumstances:
- Spillage and Wastage of materials during transit or production activity.
- The production department shall raise a requisition in form of “Additional Material Requisition Note” in duplicate for the additional requirement of raw material which shall be duly authorized by Head-QA after investigating the reason for the additional requirement for raw materials.
- After receiving the “Additional Material Requisition Note” from production, the material shall be dispensed as per the above step.
- One copy of “Additional Material Requisition Note” shall be attached in the additional material issuance file for warehouse record and a second copy shall be given to the respective department head to attach it in the BMR (if applicable).
Forms and Records (Annexures)
- Not applicable
- Master copy – Quality Assurance
- Controlled copies – Quality Assurance, Raw Material Store, Production
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