SOP for Issuance of Raw material
Raw materials are the foundation of pharmaceutical manufacturing. These essential components are sourced from various suppliers and play a crucial role in the quality and efficacy of the final product. Ensuring the purity and integrity of raw materials is vital to meet regulatory standards and deliver safe medications to patients. Robust quality control measures, including Issuance of Raw material, testing and inspection, are employed to validate raw materials’ suitability for use in pharmaceutical formulations. By prioritizing the quality of raw materials, pharmaceutical companies can uphold product integrity and ultimately contribute to improved patient health and well-being.
To lay down a procedure for the Issuance of Raw material and Cleaning of Dispensing Booths, Dispensing Tools & Dispensing Areas.
Scope: This SOP is applicable to the dispensing area of the Raw materials warehouse of the formulation plant of (Pharmaceutical Company Name).
Raw material Store personnel shall be responsible to follow the procedure mentioned in this SOP.
The raw material Store in charge shall be responsible for the implementation of the procedure mentioned in this SOP.
The concerned Department Head and QA Head shall be accountable for the implementation of this SOP.
Abbreviations and Definitions
- WH: Warehouse
- RM: Raw Material
- RLAF: Reverse Laminar Air Flow
- BMR: Batch Manufacturing Record
- : Manufacturing
- : Expiry
- SS: Stainless Steel
- v/v: Volume by Volume
- IPA: Isopropyl Alcohol
On receiving the “Dispensing of Raw Materials” sheet(s) of BMR of batch to be dispensed, the warehouse personnel shall verify the availability of the approval status of required quantity of raw materials from the “Material Stock Card” of respective materials.
Warehouse personnel shall dispense the materials as per First Expiry First Out (FEFO) followed by First in First Out (FIFO) system. The warehouse personnel shall write the AR No., Batch Number, Assay, LOD or (%) of moisture content of the API in the “Calculation of API” sheet of the BMR.
Production personnel shall calculate the exact qty. of API and excipient (with which the API is to be compensated according to standard batch size).
Before starting the dispensing activity, the warehouse, IPQA & production personnel shall ensure the following:
Area and equipments are cleaned.
Differential Pressure, Temperature and Relative Humidity of dispensing area are within the specified limit.
Documents related to previous products are removed from area.
Cleaned pallets are kept for staging of materials.
All the log books of the respective areas are updated.
Approved materials are to be dispensed.
Maximum five batches of the same product may be dispensed together.
The RLAF is switched “ON” 15 minutes before the dispensing activity starts.
Dispensing of Active & Inactive Raw Materials (Solid form):
Production personnel shall calculate the qty. of API and excipient (with which the API is to be adjusted according to standard batch size) (if applicable), as mentioned in BMR and same shall be verified by IPQA personnel.
Take line clearance from IPQA personnel before starting the dispensing activity and attach it to BMR.
Personnel entrance in dispensing area only through the personnel airlock with proper gowning.
Dispensing shall be done in controlled conditions under RLAF (Reverse laminar Air Flow).
Transfer the material from raw material approved area to the material storage area one by one through the material entry air lock.
All Inactive ingredients shall be dispensed before active ingredients, except colors and flavors, which shall be dispensed at the last.
Fill the dispensing operation details in the “Dispensing and Cleaning of Dispensing Booth Record”.
The raw materials (except API and Excipient, with which the API is to be compensated according to standard batch size), shall be dispensed as per the quantities mentioned in BMRs, in a double lined poly bag.
“Dispensed” label shall be duly filled & signed by Warehouse, Production and IPQA personnel.
The “Dispensed” label shall be filled with details like Mfg. Date & Exp. Date in case of API only and not required for the excipients.
Put “Dispensed” label in between double lined poly bag. Twist the inner poly bag, fold it in U-shape and seal it with a cable tie.
In case of light sensitive material, switch off tube lights of dispensing booth before dispensing. Dispense the material in a single black poly bag. Twist the black poly bag, fold it in U-shape and seal it with a cable tie.
Put this black poly bag in another new, transparent poly bag along with the “Dispensed” label duly filled & signed.
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 poly bag/ butter paper shall be put in a new poly bag along with the “Dispensed” label.
Record the dispensed quantity of raw material in BMR and “Material Stock Card”.
Transfer the dispensed materials to Raw Material Dispensed Quarantine area through pigmy door and keep them on clean pallets.
After dispensing, the loose packs of raw materials shall be closed, sealed and labeled with dully filled and signed “LOOSE’’ label.
Transfer the loose packs through the material entry airlock one by one to their respective storage areas.
All liquid materials shall be dispensed.
Record the dispensing activity in “Dispensing & Cleaning of Dispensing Booth Record”.
After completion of dispensing activity, the area shall be cleaned thoroughly with the help of vacuum cleaner and the same shall be recorded in “Cleaning Record for Dispensing Area & Dispensing Tools”.
API (Sterile) material shall be dispensed in intact pack after verification of canister label followed by approved status displayed on the Quarantine label.
“Dispensed” label shall be duly filled & signed by Warehouse, Production and IPQA personnel for the respective AR No. of the API (Sterile) canister.
Issuance of additional Raw materials:
The additional raw material shall be issued to production department under following circumstances:
On Line rejection.
Spillage and Wastage of materials during transit or production activity.
Production department shall raise a requisition in form of “Material Issue Slip” for the additional requirement of material duly authorized by Head-QA after investigating the additional requirement for raw materials.
After receiving the “Supplementary slip” from production, the material shall be dispensed as per step No. 6.1 to 6.2.
The details of additional materials issued shall be recorded in “Material Stock Card” and “Supplementary slip” for raw materials and attached to BMR.
Procedure for cleaning of dispensing Tools
After complete dispensing of RM for a batch, all dispensing tools shall be collected in the container or SS tray having status label “To Be Cleaned” and transfer to washing area.
All dispensing tools shall be washed with running purified water by scrubbing with Nylon Scrubber, sanitize with 70% v/v IPA and dry it by using Hot Air Oven.
After drying, all the dispensing tools shall be kept in clean and dry HDPE container lined with cleaned polythene bag attached with “Cleaned” label.
Cleaning of dispensing tools shall be recorded in “Cleaning Record for Dispensing Area and Dispensing Tools”.
Use the cleaned tools within 72 hours. If not used within 72 hours, then again clean the tools before use as per the above procedure.
Procedure for cleaning of dispensing area:
Filter & Return air Riser cleaning log shall be recorded for pressure drop for Filters before and after cleaning.
Check the electric supply of RLAF is switched-off.
The Pre Filter, Fine Filter, HEPA Filter, Riser Filter grills, SS stands and floor of the dispensing area shall be cleaned with Vacuum Cleaner.
Wipe from top to bottom S.S. grills or metal surfaces, shields, balances etc. with a cleaned wet lint free cloth with 70% v/v IPA (Iso Propyl Alcohol).
Mop the entire floor with lint free cloth wetted with disinfectant solution on rotated weekly with Domex 2.5%, Lyzol 2.5% & Savlon 2.5% with contact period of 10-15 minutes. Finally wipe entire floor with dry lint free mop.
Drain point shall be cleaned after completion of cleaning activity of the dispensing area & the Drain point cleaning record shall be recorded in Drain Point cleaning & Sanitization record.
Affix the ‘CLEANED’ label in the respective area after cleaning.
Cleaning activity shall be done after completion of the respective batch on routine basis.
Pre-Filter & Fine Filter of RLAF (Dispensing booths) shall be cleaned on fortnightly basis.
If the Differential pressure across the Pre-Filter & Fine Filter not within the limit; the respective filters shall be cleaned by the engineering department.
The Riser Filters shall be cleaned fortnightly by engineering department.
If any maintenance activity is performed in dispensing area then clean the dispensing area as per the cleaning procedure (point no. 6.5) before use.
Forms and Records
Dispensing & cleaning of Dispensing Booth Record – Annexure I
Cleaning record for dispensing area & dispensing Tools – Annexure II
Filter and return air Riser cleaning log – Annexure III
Master copy – Quality Assurance
Controlled copies – Warehouse, Quality Assurance, Production Oral/Injectable, Quality Control & Engineering
Equipment ID No.:
Dispensing time – From____To_______
Cleaning / Sanitization
Disinfectant: Yes /No
Type of filter
Filter ID No.
Pre-Filter (Limit: 1- 5)
Fine Filter (Limit: 5 – 10)
Hepa Filter (Limit: 10 – 20)
Pre-Filter (Limit: 1- 5)
Fine Filter (Limit: 5 – 10)
Hepa Filter (Limit: 10 – 20)