SOP Dispensing Procedure of Raw Materials
1.0 OBJECTIVE:
To lay down the procedure for dispensing raw material.
2.0 SCOPE:
This Standard Operating Procedure (SOP) covers the procedure for dispensing raw materials.
3.0 RESPONSIBILITY:
3.1 Store Personnel to follow the procedure
3.2 Store charge to ensure compliance of the procedure
4.0 PROCEDURE:
4.1 Pre-Dispensing Checks
4.1.1 Receive raw material requisition (Hard copy and soft copy) from the production department. For local products, ensure the shelf life of formulation products is not exceeding that of active raw materials in stock as per FIFO (First in First out). If it exceeds, inform the QA department and follow their instruction.
4.1.2 Take two copies of the printout of the FIFO allocated stock (issue slip) from a computer system (Supply Chain Management System) with the storage location.
4.1.3 Stamp the manufacturing and expiry months (which are to be referred from the issue slip) on the first page of the Batch Manufacturing Record (BMR) according to the shelf life mentioned on the same page and get it verified by QA before starting the dispensing activity.
4.1.4 Go to each material location as per the and issue slip, verify the AR No., item code, quantity, and arrange the same for dispensing.
4.1.5 Enter the detail on the status board of dispensing room, i.e., product name, batch no., batch size, status, date, and signature of store personnel.
4.1.6 Dispensing shall be done in a sequence of Inactive ingredients other than solvents first, then active material, colors & flavors, and finally solvents.
4.1.7 The temperature limit during dispensing activity shall be not more than 300C and relative humidity not more than 60% or as specified in the respective BMR. If it exceeds the specified limit, stop the dispensing activity and inform the maintenance department for rectification. After achieving the desired limit, dispensing shall be started.
4.2 Dispensing of Active ingredients & Excipients
4.2.1 Enter the dispensing room as per SOP for entry and exit to the dispensing room.
4.2.2 Record the differential pressure as per the respective SOP.
4.2.3 Ensure all the Magnehelic gauge readings of reverse laminar airflow (RLAF) are at ‘0’ reading, record the finding (of HEPA filter) in the logbook for dispensing as per Annexure I and operate RLAF as per respective SOP.
4.2.4 Calibrate each weighing balance as per respective SOPs.
4.2.5 Arrange all necessary accessories, such as cleaned scoops /spoons, fresh poly bags, clean, dry cotton cloths, cable ties, disposable hand gloves, cutter, scissors, permanent marker pen, cleaned pallets, cleaned drums / SS containers, etc., for dispensing.
4.2.6 Record product name, batch number, current temperature, and relative humidity, and other details as per the format of dispensing log book.
4.2.7 Fill the line clearance sheet in BMR and take line clearance from QA personnel by signing on the BMR and in dispensing logbook.
4.2.8 The person who is giving the material inside for dispensing through the pass box shall follow the procedure mentioned below for each material to be dispensed.
4.2.8.1 Mop the outer surface of material containers for dispensing with a clean, dry cotton cloth.
4.2.8.2 Open the pass box, transfer the raw material to be dispensed to dispensing room through the pass box and, close it.
4.2.8.3 Transfer only one item at a time to dispensing room; receive the open container of that item after dispensing, and then the next item shall be given inside for dispensing.
4.2.9 Store person and QA person shall cross-check the labels on each container for details such as item code, material name, and A R number as per the issue slip and shall check for the retest and expiry dates before starting dispensing of the corresponding item.
4.2.10 Wear disposable hand gloves and ensure the same is disposed of after weighing, i.e., use different disposable hand gloves for each material.
4.2.11 Open the material container with the help of a cutter / scissor within the boundary of the safe working area (marked with a red line) of RLAF.
4.2.12 Use dedicated scoops for active and separate scoops for each inactive material.
4.2.13 Keep the container / double polythene bags on weighing balance and allow the reading to stabilize. Record the reading in the issue tag as the “Tare weight” column in the SCM system as well asand in BMR requisition.
4.2.14 Derive the gross weight to be dispensed by adding the net weight and tare weight on the issue tag.
4.2.15 Transfer and weigh solid/liquid material from the original container to double polythene bags kept in RMC drum / double polythene bags / cleaned SS containers kept on the weighing balance and make it to gross weight as per issue tag using cleaned SS scoop/spoon or direct transfer of original drum/bag of raw material.
4.2.16 Handle the empty containers and bags after consuming material as per SOP for disposal of scrap.
4.2.17 Enter balance id no. and lot/stage no (if applicable) on the issue tag.
4.2.18 Take printa out of issue tags 2 copies each for solid materials and a single copy for solvents) from SCMthe system for each material to be dispensed.
4.2.19 Sign on the issue tags issued by store personnel, and QA personnel shall sign on checked by.
4.2.20 Fill the details in rathe w material requisition sheet (BMR) in duplicate, sign on dispensed by /performed by, and QA personnel shall sign on checked by.
4.2.21 Put used scoops and spoons in a dedicated plastic container labeled “Used Scoops.”
4.2.22 Remove material from the weighing balance and ensure the display show zero reading.
4.2.23 Close and tie the inner polythene bag with a cable tie and insert one copy of the filled issue tag between two polythene bags, other than liquids.
4.2.24 Close and tie the outer polythene bag with a cable tie and affix the second copy of the issue tag on the outside portion of the bag / container.
4.2.25 Close and tie the leftover quantity with a cable-tie; fill loose material detail label in duplicate, affix one copy outside the material container and keep the other copy inside the material container, close the container and wipe it externally with a cotton mop.
4.2.26 Keep the loose raw material whose original packing (during receipt) is in rexin bags (paper bag if required) in a dedicated loose container and handle it as per SOP for handling dedicated containers.
4.2.27 Transfer open container to its designated place through the pass box.
4.2.28 Wipe the outer portions of the weighing balance with a cotton mop.
4.2.29 Follow the same procedure as per point nos. 4.2.8 to 4.2.27 for dispensing the other items.
4.2.30 Arrange all dispensed materials in plastica containers with lot wise / stage-wise segregate them over plastic pallets onin its designated place, and a fill and affix dispensed raw material label on each raw material container (RMC).
4.2.31 If any , color is there to be dispensed, clean the RLAF as per respective SOP, take line clearance from QA, record the activity in dispensing logbook as per Annexure I an,d then dispensing shall be done.
4.2.32 Record the end time of the batch dispensed in dispensing logbook and in BMR onthe completion batch.
4.2.33 Continue running the RLAF for not less than 5 minutes on completion of dispensing and then switch off the RLAF and weighing balances.
4.2.34 Transfer the dispensed material to the RM day room.
4.2.35 Handle the scrap as per SOP for handling scrap materials.
4.2.36 Transfer the used scoops to the wash area through the material pass box and clean it as per SOP for cleaning of scoops.
4.2.37 Clean the dispensing area and equipment as per respective SOPs.
4.3 Dispensing of Solvents:
4.3.1 Arrange and transfer the cleaned s.s.containers for dispensing the solvent materials from the RM Day room to the solvent room.
4.3.2 Wear protective accessories like a nose mask, safety goggles, and rubber hand Gloves and enter the solvent room. Record the start time, weighing the balance id number in BMR.
4.3.3 Calibrate the weighing balance as per the respective SOP.
4.3.4 Keep the cleaned SS container where material is to be dispensed on the weighing balance and record the reading in the issue tag as ‘Tare weight’wColumneight. column in SCM system as well as in BMR requisition.
4.3.5 Derive the gross weight to be dispensed, by adding the net weight and tare weight on the issue tag. Enter balance id no. and lot/stage no (if applicable) on issue tag.
4.3.6 Store person and QA person shall cross check the labels on each container for details such as item code, material name and A R number as per issue slips and shall check for retest and expiry dates before starting dispensing of the corresponding solvent.
4.3.7 Transfer the respective solvent from the original container to cleaned SS containers kept on the weighing balance and weigh to gross weight as per issue tag using dedicated solvent dispensing pumps.
4.3.8 Remove the dedicated dispensing pump from the solvent container if the material to be dispensed is not sufficient; attach the same on the next immediate container as per A R no. and continue the dispensing activity.
4.3.9 Remove SS container from weighing balance after weighing and ensure display shows “0.00” reading.
4.3.10 Take print out of issue tags one copy each for solvent material to be dispensed.
4.3.11 Sign on the issue tags on issued by store personnel and QA personnel shall sign on checked by.
4.3.12 Cover the SS container with fresh polythene bags and tie it with nylon thread (if applicable) or cover with SS lid.
4.3.13 Fill and affix the loose material detail label on loose drum.
4.3.14 Record the end time of dispensing in BMR. On completion of solvent dispensing record the “ log Book “ as per Annexure II.
4.3.15 Cross all the labels on empty original containers after consumption of material. Attach label “scrap to be disposed off” duly signed with date on empty drums and transfer to the scrap yard.
4.3.16 Fill details in raw material requisition sheet in duplicate, sign on dispensed by / performed by and QA personnel shall sign on checked by.
4.3.17 Cover the attached dedicated dispensing pumps again with fresh polythene bags after completion of the dispensing activity.
4.4 Receive and file the duplicate copy of raw material requisition sheet and ensure production personnel has signed on received by column.
4.5 Issue of extra raw materials
4.5.1 Receive extra material requisition slip from Production Department, (hard copy and soft copy ) duly approved by QA head and unit head or their designees and issue materials as per point no. 4.2 for solid materials and as per point no. 4.3 for solvents.
4.6 In case if there is any excess/shortage of any A R no. found during dispensing, do correction in SCM for the corresponding AR no., and Reconcile the corresponding A R no. as per SOP for reconciliation of raw materials.
4.7 During Inter location transfers
4.7.1 Receive inter-location transfer notes from the purchasing department for transferring the approved / quarantine / under-test raw material and follow the procedure as below.
4.7.2 Punch quantity to be transferred in the computer system and generate non-returnable gate pass.
4.7.3 Take printout of the Identification label from the computer system and paste it on each material container to be transferred.
4.7.4 Prepare the material transfer note, get it approved by plathe nt head or his designee a,nd hand over to exthe cise department for necessary excise documentation.
4.7.5 Take Photocopy of COA from QA dept. against each A R no. of the material to be transferred.
4.7.6 Dispense the material to be transferred if the required quantity is not as per standard packs or its multiples of the material to be transferred, as per point no. 4.2 for solid materials and as per 4.3 for solvents.
4.7.7 Ensure the duplicate for transporter copy or non-cenvat certificate is received from BSR department and a Photocopy of COA against each A R no. of the material to be transferred from Qthe A department.
4.7.8 Compile and cross-verify all the documents with the material dispensed for transfer, load the materials to the vehicle in presence of security personnel and hand over the documents to security for outward entry.
4.7.9 Receive the store copy of the non-returnable gate pass from security and file for store records.
Note: In case the instruction written in Hindi language is wrothe ng treat the instruction given in English is correct.
5.0 ANNEXURE:
Annexure I – Log book for dispensing of raw material.
Annexure II – Log book for solvent dispensing