Dispensing of raw material

Dispensing of raw material

OBJECTIVE 

• Procedure of dispensing raw materials.

SCOPE 

• This SOP is applicable for dispensing of all raw materials.

RESPONSIBILITY 

• Warehouse, production and QA staff shall be responsible to follow the procedure mentioned in this SOP.

ACCOUNTABILITY 

• Warehouse In-Charge and QA Head shall be accountable for compliance of the procedure mentioned in this SOP.

ATTACHMENTS 

• Label “Dispensed Material” (cage label)                                                                           -Attachment I
• Label “Dispensed Material”                                                                                    -Attachment II
• Label “Loose”                                                                                                               -Attachment III

PROCEDURE

• Check and verify the dispensing Requisition sheet.
• Inform QA and Production Department about the dispensing.
• Check whether the Dispensing booth, weighing balances, SS bowls, scoops, spoons, and transfer pump for liquids are clean and obtain line clearance from QA.
•  Check the weighing balance according to the calibration status and enter the details in the checklist.
• Check and enter the pressure difference of the dispensing booth in the checklist.
• Check the QC approved label.

1. Name of the material
2. Batch No.
3. A.R.No.
4. Assay
5. LOD
6. Sign by
7. Re-test date
8. Date

• Dispense materials following “First in First Out” order (FIFO).
• Transfer the Raw materials required for the batch to the dispensing area.
• Operate the dispensing booth as per the standard operating procedure and dispense the raw material inside the dispensing  booth.
• Use dedicated scoops for dispensing of the active materials.
• The dispensed materials shall be placed in the designated steel cages with locks. Each cage shall have the label  (Attachment I) that must have the following details:

1. Product Name
2. Batch No.
3. Batch Size
4. Date
5. Date
6. Lot No.
7. Weighed by
8. Checked by
9. Date

• Sequence of raw materials dispensing 
• Dispense the excipients in the dispensing booth first, and then remove them from dispensing area.
• Dispense active ingredients.
• Dispense the colorants after dispensing of active ingredients.
• Dispense raw materials in double polyethylene bags and tie them with a nylon thread or with a hose tie.
• Record the entries of A.R. No., Quantity dispensed (Gross wt., Tare wt. and Net. wt.) in the application, the entries must be checked and signed by Production and QA.
• Affix the label on the dispensed material.
• The label must have the following details (Attachment II).

1. Product Name
2. Batch No.
3. Name of the material
4. A.R. No.
5. Quantity dispensed (Gross wt., Tare wt. and Net. wt.)
6. Date of dispensing
7. Dispensed by
8. Checked by
9. Received by
10. Date

• Make necessary entries about the quantity of dispensed material.
• If the same API is dispensed with two different A.R.No., dispense and label them separately.
• Always remove only one material at the same time to avoid cross contamination.
• Dispensing of solvents for liquid orals and for tablet coating is done with the help of special food-grade SS pump to the SS containers (SS316) provided with screw type lid.
• After dispensing of solvents the pump is taken to the Wash Room of Dispensing Room, it is washed with a sufficient quantity of purified water and it is wiped out with a dry lint free cloth.
• The label “Cleaned” shall be pasted on the clean equipment.
• Enter the details about the dispensing booth operation and cleaning detail in the log book
• After completion of dispensing process, the loose containers with raw materials shall be weighed and the    label  “Loose”  shall be paste on them (Attachment III).
• The “Loose” label must have the following details.

1. Date
2. Product Name
3. Batch No.
4. Quantity
5. Checked by

REFERENCES

• In-house

ABBREVIATIONS 

• QA: Quality Assurance
• QC: Quality Control
• Mfg. & Exp.: Manufacturing & Expiry
• FIFO: First in first out
• AR: Analytical report

DISTRIBUTUON LIST 

• Quality Assurance Department
• Production Department
• Warehouse Department

 HISTORY OF REVISION

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