- OBJECTIVE:
- To lay down the procedure for arranging of materials for sampling and dispensing (RM/PM).
- SCOPE:
This SOP is applicable for the procedure for arranging materials for sampling and dispensing (RM/PM) at {Company Name} {Location}.
- RESPONSIBILITY:
- WH Executive/Designee – is responsible for ensuring compliance with the SOP.
- Head Warehouse – is responsible for compliance of the SOP.
- ACCOUNTABILITY:
QA Head shall be Accountable for implementation of SOP.
- PROCEDURE:
- SAMPLING:
- Warehouse personnel shall send the vender COA to QC by mentioning MRR No. (Material received receipt) on vender COA.
- QC personnel shall verify the identity of the materials with respect to name of the Material, Material code, Batch No, Lot No., Mfg. dt. and Exp. dt.
- Transfer the material to be sampled to the staging area of the respective sampling room through the pass box.
- Ensure that every container/Package shall be having Under Test label.QC personnel shall enter into the sampling area through Men Entry.
- The warehouse person shall arrange the materials for sampling.
- The respective material shall be collected inside by the sampling personnel.
- The outer surface of the material containers shall be cleaned prior to arranging for sampling.
- The material shall be arranged one after the other as mentioned in the sampling plan.Materials shall be sampled under the LAF.
- On completion of the sampling, transfer the used spatulas/spoons to wash area in a Bin kept for the purpose of cleaning.
- After completion of sampling, QC Executive shall affix label as ‘SAMPLED’ on the sampled container with sign and date.
- All the sampled drums/containers shall be sealed with plastic seals.All sampled bags shall be tied tightly with plastic seals.
- All loose boxes shall be closed with cello tapes. Bopp tapes are restricted to use for raw materials.
- Sampled Container/drums/packs shall be sent back to respective storage area.
- Collected sampled material shall transfer to QC.Switch off the LAF and exit through the Men entry.
- Clean the sampling area. As per the current version SOP.In case of API, sample the material as per SOP.
- DISPENSING:
- After receiving the BMR and BPR from the production, Warehouse personnel shall collect the lot numbers as per FIFO basis.
- Warehouse personnel shall transfer the required materials from its respective lots to respective material entry.
- Ensure that every container/package is having approved label.
- The outer surface of the material containers shall be cleaned prior to arranging the materials for the dispensing.
- Dispensing personnel shall enter into the respective dispensing room through the men entry.
- Dispensing personnel shall collect the material from material entry and keep it in “To be dispensed material hold area”.
- Dispensing personnel shall dispense the material as per the SOP.
- After completion of dispensing, dispensing personnel shall keep the left-over material in material entry with updated loose container tags.
- The material shall be arranged one batch after the other batch as mentioned in the dispensing plan.
- After completion of dispensing, materials in the original pack shall be sent back to the respective material storage area.
- All the dispensed drums/containers shall be sealed with plastic seals.All loose boxes shall close with cello tapes.
- Bopp tapes are restricted to use for raw materials.
- Dispensed material shall be transferred to dispensed material hold area by dispensing personnel.
- Switch off the LAF and exit through the personnel entry.
- Clean the dispensing area as per the SOP.In case of API, dispense the material under isolator as per SOP.
- SAMPLING/DISPENSING:
- Materials shall be moved through the Materials entry only to the dispensing and sampling areas
- Personnel shall be moved through the men entry only to the dispensing and sampling areas.
- CAUTION:
- Before sampling/dispensing, Warehouse personnel shall ensure the cleanliness of sampling area, dispensing area, balances, material handling equipments.
- The LAF should be switched on 15 minutes before the start of sampling activity/dispensing activity.
- Use separate cleaned spatula/spoons/scoops for sampling/dispensing of each inactive and active material.
- Sampling/dispensing shall be carried out within the Safe Working Zone only.
- Ensure that the differential pressure reading of sampling/dispensing booth is within the accepted limit.
- In case of API, sample the material as per SOP.
- Dispense API through as per SOP.
- Use SS containers for dispensing of small quantity of API.
- REFERENCES:
Not Applicable
- ANNEXURES:
Not Applicable
ENCLOSURES: SOP Training Record.
- DISTRIBUTION:
- Controlled Copy No. 01 : Head Quality Assurance
- Controlled Copy No. 02 : Head Warehouse
- Controlled Copy No. 03 : Head Quality Control
- Master Copy : Quality Assurance Department
- ABBREVIATIONS:
| No. | : | Number |
| LAF | : | Laminar Air Flow |
| COA | : | Certificate of analysis |
| SOP | : | Standard Operating Procedure |
| BMR | : | Batch manufacturing record |
| BPR | : | Batch packing record |
| FIFO | : | First in First Out |
| MRR | : | Material received receipt |
| API | : | Active Pharmaceutical Ingredient |
| SS | : | Stainless steel |
| QA | : | Quality Assurance |
- REVISION HISTORY:
CHANGE HISTORY LOG
| Revision No. | Details of Changes | Reason for Change | Effective Date |
| 00 | New SOP | Not Applicable | To Be Written Manual |
Frequently Asked Question?
Q: What documents are verified before sampling?
A: Vendor COA with MRR No. and material details (name, code, batch, lot, manufacturing & expiry dates).
Q: How are materials prepared for sampling?
A: Material transferred to staging area, outer surface of material shall be cleaned and arranged according to sampling plan.
Q: Where does sampling take place?
A: Under a Laminar Airflow (LAF) hood.
Q: What happens to used sampling tools?
A: Transferred to a designated cleaning bin.
Q: How are sampled containers marked and secured?
A: Labeled “SAMPLED”, sealed with plastic seals, and tied tightly for bags.
Q: How are materials selected for dispensing?
A: Based on BMR and BPR, using FIFO method and lot numbers.
Q: What checks are performed before dispensing?
A: Approved label on container, clean outer surface.
Q: Where does dispensing take place?
A: In a designated dispensing room.
Q: What happens to leftover materials after dispensing?
A: Returned to material entry with updated tags.
Q: How are dispensed containers secured?
A: Sealed with plastic seals for drums and closed with cello tapes for boxes.
Q: What are the key safety precautions for sampling and dispensing?
A: Ensure cleanliness of areas, equipment, and tools. Turn on LAF 15 minutes prior. Use separate tools for each material. Operate within safe zones. Follow API-specific SOPs.
Q: How are personnel and materials moved in and out of the sampling and dispensing areas?
A: Through designated entry points for materials and personnel. Material enrty for material and man entry for man.