RM DISPENSING IN PHARMA (PICTORIAL)

1.0 PURPOSE

To define the procedure for GMP-compliant dispensing (weighing) of raw materials for manufacturing, ensuring correct identity, quantity, status and traceability.

2.0 SCOPE

Applicable to all raw materials (API + excipients) dispensed for oral solid dosage manufacturing in the dispensing / weighing area.

3.0 RESPONSIBILITY

• Store / Warehouse
  • Dispense materials as per approved MFR / BMR.
  • Maintain RM status, labels, and records.
• Production
  • Verify material (name, batch, qty) vs BMR.
  • Use only correctly dispensed & labeled RM.
• QA / IPQA
  • Line clearance & in-process checks (if applicable).
  • Verify correctness of dispensing and documentation.

4.0 PRE-REQUISITES

4.1 Documents & Approvals

• Approved Master Formula Record (MFR) / Batch Manufacturing Record (BMR).
• Released RM from QC (COA / “APPROVED” label).
• Current version of related SOPs (dispensing, labeling, cleaning, status labeling, etc.).

4.2 Area & Equipment

• Dispensing room cleaned, “READY FOR USE” status.
• Balance calibrated & within due date, status label “CALIBRATED”.
• LAF / RLAF / Dispensing booth ON and within required DP, Temp, RH (if applicable).
• Clean SS scoops, spatulas, polybags, containers, liners available.

4.3 Personnel & PPE

• Trained operator(s) and checker.
• Gowning as per area requirements (head cover, mask, gloves, shoe cover, etc.).

5.0 LINE CLEARANCE – DISPENSING AREA

Check & record as Yes/No/NA:

1. Area free from previous product / batch materials.
2. All previous labels, tags, documents removed.
3. Balance clean, level and calibrated (check status label).
4. Scoops, spatulas & containers clean and labeled.
5. LAF / RLAF working; DP / Temp / RH within limits.
6. Appropriate waste bins available & empty.
7. Correct BMR and dispensing sheet available.

QA / IPQA signs Line Clearance before starting (if your system requires).

6.0 SELECTION AND VERIFICATION OF RAW MATERIALS

For each RM:

1. Trace & bring required container(s) from RM store as per BMR.
2. Check the RM label thoroughly:
   • Material Name & Grade (e.g. Lactose Monohydrate IP)
   • RM Code / Item Code
   • Manufacturer, Supplier
   • Batch / Lot No.
   • Status: APPROVED (no QUARANTINE / REJECTED)
   • Retest / Expiry Date
3. Match with BMR/MFR:
   • Product name, batch size
   • Required RM, grade, and code
4. Record AR No. / QC reference (if applicable).

If any mismatch → DO NOT DISPENSE → inform QA / Store in-charge.

7.0 DISPENSING / WEIGHING PROCEDURE

7.1 General

• Use dedicated or product-specific scoops if risk assessed.
• Avoid direct hand contact; always use clean tools.
• Keep material exposure to minimum (close container between scoops).

7.2 Taring the Container

1. Select clean, dry, labeled dispensing container with poly-liner.
2. Place empty container on balance → press TARE.
3. Confirm zero before weighing.

7.3 Weighing RM

1. Open original RM container inside the booth.
2. Transfer RM slowly with scoop to dispensed container.
3. Achieve required quantity within specified tolerance (e.g. ±0.1% or as per SOP).
4. Avoid over-filling; if overweight, follow your SOP (do not simply scoop back if not allowed).
5. Once correct weight obtained:
   • Record gross, tare, net weight in dispensing sheet / BMR.
   • Operator signs and dates.
6. For partial used RM container:
   • Record remaining quantity & update stock card / ERP.
   • Reseal, label and return to store as per SOP.
7. Second check (if system requires):
   • QA / IPQA or second person re-checks RM name, batch, quantity.
   • Signs “Checked by” column.

8.0 LABELING OF DISPENSED MATERIAL

Each dispensed container MUST have a Dispensing Label, including:

• Product Name
• Batch No.
• RM Name & Code
• RM Batch / Lot No.
• Quantity dispensed (Kg / g)
• Container No. (e.g. 1/3, 2/3, 3/3)
• Status: “DISPENSED” / “FOR BATCH _______ ONLY”
• Date of dispensing
• Signatures: Dispensed by (Stores) / Checked by (QA/Production)

Stick labels firmly and ensure old/reused labels are removed or defaced.

9.0 POST-DISPENSING – TRANSFER TO MANUFACTURING

• Verify:
  • All required RM for the batch are dispensed and labeled.
  • Dispensing sheet completed and signed.
• Transfer dispensed materials to designated staging area / manufacturing room:
  • Use closed containers, carts with covers, etc.
  • Avoid cross-over of unclean / clean routes.

Production receives material and cross-checks labels vs BMR before use.

10.0 CLEANING & STATUS AFTER DISPENSING

• Remove all RM residue / spills using vacuum or approved cleaning method.
• Wipe work surfaces, balance pan, and booth surfaces as per cleaning SOP.
• Dispose of:
  • Used wipes, PPE, liners, etc. in appropriate waste streams.
• Update area status board to “CLEANED / READY FOR USE” or as per next plan.
• Enter activity in area logbook / equipment logbook.

11.0 DOCUMENTATION

Documents to be maintained:

• Dispensing sheet / Weighing sheet
• Bill of Raw Materials (BOM) – Production & Store copy
• RM stock register / ERP record
• Area & equipment cleaning records
• Line clearance records
• Any deviation / incident report raised