SOP for Dispensing of Raw material

This Document describes (Standard Operating procedure) SOP for Dispensing of Raw material

SOP for Dispensing of Raw material

I. Purpose & Scope:

• The purpose of this SOP for dispensing of Raw material.
• This Standard operating procedure shall be applicable for Dispensing of Raw materials

II. Responsibilities:

• All warehouse personnel shall be responsible to follow and implement this SOP.

III : Introduction and Procedural Part:

Prerequisites  for dispensing of Raw material :

• The production request should receive by warehouse from production 48 hrs before batch planning.
• Store department shall verify the material against BOM & stock register as per  FIFO
• FIFO can be deviated incase of First Expiry First Output materials or there is specific requirement of grade of materials or manufacturer according to approved vendor list for EU/US market, No need to raised the deviation. FIFO shall be deviated incase subsequent materials is having less expiry (FEFO) than first AR.No.
• In case of Assay is less than 100%, potency calculation shall be done as per respective Batch Manufacturing record. Calculation shall be done by Production and verified by QA. The extra quantity of API shall be compensated with excipients quantity as per respective BOM & Assay calculation sheet as specified in the BMR.
• Store shall verify the following details:
• Name of the material.
• R. No.
• Manufacturing date.
• Expiry date.
• Reanalysis (Retest) date.
• Quantity
• As per BOM received from production department all the required approved raw material shall be removed on the pallet from storage rack and same shall be arranged near to material staging area.
• Excipients shall be dispensed first followed by active pharmaceutical Ingredient.
• Materials returned under Material return note (MRN) shall be dispensed first.
• Loose label shall be crossed while issuing for the next batch.
• Balance shall be selected for weighing as per their capacity/least count
• Ensure all the Raw material shall be dispensed on doers / checker system.
• In case of power failure, below mentioned points shall be adhered to.
• Close and fasten the open polythene bags with nylon threads /fasteners.
• Re-calibrate the balances and record.
• The dispensing activity shall be commenced only after the environmental conditions are achieved viz. Pressure differential, Temperature and RH in the room and power to the RLAF.
• Record the time of power failure in dispensing log.
• Light sensitive material shall be dispensed under sodium lamp lighting & secondary poly bag shall be black or as instruction given in the BMR.

Line Clearance :

• Ensure that dispensing area is cleaned as per SOP
• Ensure that before starting dispensing activity all the electronic balances are calibrated
• Ensure that RLAF unit is put on 30 minutes before start up the activity.
• Ensure that Relative humidity (RH) and Temperature of the area are maintained as required by the respective Batch manufacturing record (BMR).
• Ensure that Pressure differential of the area is maintained as required for the area and shall record the same in RLAF log book
• Ensure that dispensing area is clean and status board is updated.
• Ensure that batch documents, labels, materials of the previous batch/campaign are not available in area.
• The Q.A. officer shall give line clearance before start up dispensing activity and record in the respective BMR.

Batch Dispensing/ Dispensing of Raw material :

• The dispensing operator shall take out dispensing utensil such as scoops from the bag labeled as “Cleaned”. The workmen in store (outside dispensing area) shall bring required raw materials for dispensing in material airlock and transfer the same, one by one, to dispensing area.
• Use clean double polybag and fastener of appropriate size for dispensing of materials.
• In case of liquid material, SS container with closed lid of appropriate size shall be used.

Dispense the material as mentioned in BMR as per following sequence :

• Excipients
• Flavor
• Color
• API (Active Pharmaceutical Ingredients)
• API shall be dispensed after issuance of excipients at the end of batch dispensing.
• During each material weighing, ensure zero level & zero on weighing scale before proceeding for dispensing.
• Carry out the dispensing operation under reverse laminar air flow work station. Person performing the dispensing activity should stand in a way to face the return air filter side.
• IPQA Officer and production officer shall verify the following details.
• Name of the material.
• R. No.
• Manufacturing date.
• Expiry date.
• Reanalysis (Retest) date.
• Quantity
• After dispensing of each excipients, dry mopping shall be performed to remove any spilled material from balances, table, RLAF by vacuum cleaner or dry mopping by lint free cloth, Type B cleaning shall be performed after completion of each API dispensing or after completion of batch. The details shall be recorded in the “Raw Material Dispensing Log”.
• After completion of dispensing of raw material activity, Put the “TO BE CLEANED” label on dispensing tools.
• In case of any adverse observation during dispensing report to Head of QA for corrective action.
• Transfer the material to be issued through material entry pass box.
• All raw materials shall be dispensed one by one in dispensing rooms under RLAF.

Batch Dispensing Procedure Operation:

• Step-I: Area Readiness (Line Clearance): Take line clearance from QA personnel before start of dispensing operation.
• Step-II: Dispensing Operator Position: Dispensing operator shall stand outside the yellow color line marked under RLAF during dispensing operation.
• Step-III: Materials Container’s Position: Put the container on square in RLAF marked in yellow color.
• Step-IV: Position of dispensing operator and materials: Dispensing operator shall stand outside the yellow color line marked under RLAF and materials container shall remain within yellow color under RLAF during dispensing operation.
• Step-V: Putting of double LDPE bag on balance platform and tare: Keep the clean containers / new poly bag on weighing balance and record the weight of empty container / new polybag on weighing slip and tare the weight by pressing “Tare” press button.
• Step-VI: Materials Transfer: Transfer the required quantity of raw material into the tare weight of container/bag by using cleaned dispensing tool. Store officer shall record the dispensing details on dispensing label by mentioning item code, A.R. No., Net weight, Gross weight and Tare weight with product name, Batch No. , Batch size and Lot No.
• Step –VII: Closing of inner bag of dispensed materials with Fastener/plastic tie: After transfer of the required net quantity of material into poly bag/clean container, dispensing operator shall airtight the inner poly bag with help of nylon thread or cable tie or container by closure.
• Step-VIII: Closing of outer bag after putting of dispensing materials between inner and outer: After airtight closure of inner poly bag, Outer bag shall be tied with fastener and put the dispensing label in-between two poly bags.
• Step-IX: Transfer of dispensed materials to palette or pass box: Transfer the tied dispensed material in double poly bag with dispensing label to palette or pass box of the respective area.
• Step-X: Closing of loose container: After dispensing, in case any balance quantity of the material is left in original container/ bag, Airtight the inner poly bag of loose container with help of nylon thread or cable tie and then outer poly bag.
• Step-XI: Affixing of loose container label: The stores officer shall prepare and affix “Loose” label (in case any balance quantity of the material is left in original container/ bag) as per Annexure III on outer container. After labelling to loose container (as applicable) transfer the loose container to designated location of warehouse.
• Step-XI: Verification of area after cleaning: After dispensing of each raw material, wipe the balance platform with dry lint free cloth.
• Follow the same procedure, for dispensing of other excipient materials.
• At the time of next dispensing of raw material, loose container /bag should be taken first for issue.
• Ensure that all materials are scooped and never be issued intact to production.
• Use cleaned scoop for each API and excipients.
• The production officer shall put his initial in the column marked as “checked by” and IPQA officer shall initials in the column “Verified by” on Material Issued to Production against each and every raw material.
• The stores officer shall record all materials dispensing of raw material activity in Annexure-I. immediate after completion of each raw material.
• Store officer shall update raw material stock register on completion of dispensing of raw material activity.
• The production officer shall be responsible for transferring the dispensed raw materials from “Staging Area” to respective manufacturing area.
• Deface all the labels of empty containers/ bags/ boxes with cross marking and transfer them to the scrap exit room.

Dispensing activity in case of campaign :

• Up to 5 consecutive batches in a day is allowed in campaign dispensing.
• Dispensing shall be performed in accordance of point no. 5.2
• Dispensing shall be done item wise e.g. There will be 5 batches to be dispensed for product “X” starting from batch no. xxxxx001 to xxxxx005.
• In product “X” 5.75 Kg of Maize starch is required as one of the excipients.
• Dispensing of 5.75 Kg. of Maize Starch shall be done 5 times in separate polybags and then labeling shall be done accordingly.
• These 5 numbers of 5.75 Kg. of Maize Starch for batch number xxxxx001 to xxxxx005 shall be kept in 5 groups.
• After Maize starch, next item prescribed in the BOM of the product “X” shall be dispensed and kept in the group of batch number xxxxx001 to xxxxx005.
• All excipients shall be dispensed and kept in the group of batch number xxxxx001 to xxxxx005.
• After completion of dispensing of raw material i.e. excipients, API shall be weighed for 5 consecutive batches.

Dispensing of EHG Capsule :

• Calculate the number of EHG capsules to be dispensed with average weight of capsule or number Weight of EHG shells to be dispensed= Number of capsules required x Average Weight of EHG shells(mg) / ( 1000 x 1000).

Dispensing of solvents :

• The dispensing shall be performed in Solvent room.
• All requisite solvents drums such as IPA & Methylene chloride/ Dichloro Methane/acetone shall be dispensed in Solvent store.
• Dip the dedicated barrel pump in to the bulk container/drum.
• Use cleaned barrel pump for dispensing
• Weigh & prepare the Dispensing slip for individual lot of dispensed material.
• The stores officer shall record all materials dispensing activity in Annexure-II immediate after completion of dispensing activity.
• After completion of dispensing, transfer the barrel pump &silicon tubing wrap with stretch film and transfer to washing area for cleaning.
• Clean the barrel pump & silicon tubing with potable water.
• Ensure that drum is sealed appropriately after end of dispensing activity.

IV: Annexure :

Annexure – I  : Raw material Dispensing Log

Annexure – II :  Solvent Dispensing log

Annexure – III: Loose Container/Bag Label

ANNEXURE-I

RAW MATERIAL DISPENSING LOG

 ANNEXURE-II

SOLVENT DISPENSING LOG

ANNEXURE III

                                                                                                       LOOSE CONTAINER/BAG LABEL