Standard Operating procedure (SOP) for material movement in pharmaceutical manufacturing premises form dispensing to the final product. whether material movement from one department to another or within the department.
SOP for Material Movement In Manufacturing Premises
- The purpose of this SOP is to lay down the procedure for material movement procedures in the pharmaceutical manufacturing premises.
- The procedure is applicable to the pharmaceutical manufacturing premises.
- To movement the material within the department
- To movement the material to and from the department
3.1 SOP for Storage of In-Process / Bulk finish Product in Quarantine Area
4.1 Production Department:
4.1.1 Responsible for the movement of materials, to, from and within the department as per the defined procedure.
4.1.2 To check and ensure the cleanliness of storage containers, suitably labeled and stored.
4.2 Quality Assurance Department:
4.2.1 To ensure the movement of material to, from, and within the department as per the defined procedure.
4.2.2 To approve bulk tablets for packaging
4.2.3 Ensure proper implementation SOP.
4.3 Quality Head and Plant Head or Designee is responsible to review and approve of SOP
5.0 ABBREVIATIONS USED IN SOP FOR MATERIAL MOVEMENT:
5.1 BMR: Batch Manufacturing Record
5.2 BPR: Batch Packing Record
5.3 SS: Stainless steel
5.4 QA: Quality Assurance
5.5 HSMG: High Shear Mixer Granulator
5.6 RMG: Rapid Mixer Granulator.
5.7 MRO: Material Requisition Oder
5.8 FBD: Fluid Bed Drier
5.9 SOP: Standard Operating Procedure
5.10 IPC: In process Container
5.11 HDPE: High-Density Polyethylene
5.12 OHCR: Over Head Compression Room
5.13 IPQC: In Process Quality Checks
5.14 ERP: Enterprise Resource Planning
5.15 EHG: Empty Hard Gelatin
5.16 BSR: Bonded Store Room
6.0 DEFINITION: NA
7.0 PROCEDURE OF MATERIAL MOVEMENT:
Any requirement given in BMR/BPR for a particular product shall supersede the procedure mentioned in the SOP.
7.1 Ensure During any Operation:
7.1.1 Do not take two different products for processing in a single cubicle.
7.1.2 Do not take two different batches of the same product for processing in a single cubicle at a time. i.e. Take the second batch inside the cubicle only after the first batch taken out of the cubicle.
7.1.3 Different lots of a single batch can take for processing in a single cubicle with proper labeling and segregation.
7.1.4 Continue the processing in a cubicle while the adjoining cubicle of the same section subjected to wet cleaning if no processing is to be done in that cubicle.
7.1.5 In Processing area I, Do not take two different products for processing at a time.
7.1.6 Before starting any activity, check the Inner and/or outer label of the container/materials as per label details against the BMR / BPR.
7.1.7 After loading any material to the next step of the process, remove and discard the used poly bags from the drums and ensure that no residue is left inside the drum.
7.1.8 After ensuring the absence of residue put new polybags and new labels and make it ready for the next stage if the same containers are used.
For example, after loading core tablets to Coating pan remove and discard old poly bags and ensure no residual tablet is left in the container and then put new polybags and new labels.
7.2 Movement of materials from Raw material Staging to the department:
7.2.1 Check the materials as per MRO / BMR before transferring to the manufacturing area.
7.2.2 Transfer the materials from the raw materials staging room using pallet trolley to the required cubicle.
7.2.3 Handle the solvents carefully during transfer to the required cubicle.
7.2.4 Transfer all materials required at the ground floor through the hoist.
7.3 Movement of materials within the department: Sifting & Milling.
7.3.1 Transfer the materials from raw materials staging room to the sifter cubicle.
7.3.2 Transfer the materials manually for sifting to sifter using SS scoops and collected in polyethylene bag lined and duly labeled containers.
7.4 Movement of material within the department: Binder solution
7.4.1 Collect and weigh the required quantity of Purified water as per BMR in duly labeled cleaned SS container and transfer to the required area.
7.4.2 In case of paste kettle, after preparation of paste/binder, transfer the container to the required area in closed condition using the trolley.
7.5 Movement of material within the department: Granulator
7.5.1 Transfer the sifted materials to the granulation area using a trolley or manually.
7.5.2 Transfer the sifted material to the platform of the Granulator by lifting the containers manually and placing them on the platform carefully.
7.5.3 Load all raw materials into RMG manually by SS scoop or by lifting and tilting the container.
7.5.4 Add binder solution to RMG via the addition port using scoops or jugs or measuring vessels manually or by means of peristaltic pumps as per BMR.
7.6 Movement of material within the department: Wet Milling
7.6.1 The wet granules formed after the granulation process shall be wet-milled by using Co-mill and directly collected/stored in previously cleaned, duly labeled FBD bowl/container.
7.7 Movement of material within the department: Drying (FBD)
7.7.1 Transfer the granules in the FBD bowl to the drying room in closed condition.
7.7.2 After drying transfer the dried granules to the milling / sifting area through the airlock.
7.8 Movement of material within the department: Roll Compactor
7.8.1 Transfer the lubricated blend into the hopper of roll compactor manually using SS scoops for compaction.
7.8.2 Then collect the slugs in polyethylene bag lined and duly labeled containers.
7.9 Movement of material within the department: Milling
7.9.1 Transfer the dried granules/slugs into the mill hopper for milling manually using SS scoops.
7.9.2 Collect milled granules in polyethylene bag lined duly labeled containers.
7.10 Movement of material within the department: Lubrication / Blending
7.10.1 Transfer dry milled and sifted granules along with lubricants to the blending room using a trolley or manually.
7.10.2 Load all materials into the blender by lifting and tilting the containers manually in sequence wise as per BMR.
7.10.3 Unload the blended material in polyethylene bag lined duly labeled containers or keep in the same bunker.
7.10.4 Check the blended material for weight by production and then transferred to the quarantine area or to the next stage as per requirement.
7.11 Movement of material within the department: Pelletization
7.11.1 Transfer the wet mass into the hopper of Extruder for extrusion manually using SS scoops.
7.11.2 Collect directly the extrusion in polyethylene bag lined duly labeled container.
7.11.3 Then transfer the extrusion to the hopper of Spheronizer for Spheronization manually.
7.11.4 Collect the spheroid pellets in a previously cleaned, duly labeled containers.
7.12 Movement of material within the department: Compression
7.12.1 Take the blended granules to the respective compression room by using the trolley.
7.12.2 Weight the Lubricated granules before taking for compression.
7.12.3 Load the granules into the hopper manually by SS scoops on the top of the hopper of the compression machine.
7.12.4 Take the blended granules in the bunker to the OHCR, over the respective compression room.
7.12.5 Load the granules into the hopper of the compression machine by using distance piece and Y chute.
7.12.6 Collect the compressed tablets in duly labeled polyethylene lined drums/containers.
7.12.7 During compression, Collect the tablets in a sample bag with a proper status label and sent it to the IPQC room for in-process checks.
7.12.8 After completion of compression, Check the tablets for weight by production and then taken by using a trolley to the Intermediate store or to the next stage as per requirement.
7.12.9 All recoverable recovery after completion of compression. Transferred to the granulation department with proper labeling, after taking a recovery receipt in the ERP system.
7.12.10 Keep the recovery tablets/granules in polyethylene bag lined duly labeled container. Mention quantity returned on the label duly received by the production supervisor and keep at the designated place.
7.13 Movement of material within the department: Coating Solution / Suspension
7.13.1 Perform the material sifting/ movement as per the sifting procedure as mentioned above.
7.13.2 Mix the sifted material and solvent in SS vessels along with the addition of the solvent as per BMR.
7.13.3 Mill the prepared slurry by transferring the slurry to the mill hopper using lifting and tilting the SS vessel along with solvent or as per BMR.
7.13.4 Collect the milled coating suspension in duly labeled SS vessels / Solution tank.
7.13.5 Coating Solution / Suspension also can be prepared by using a stirrer.
7.14 Movement of material within the department: Coating
7.14.1 Transfer the tablets for the coating to the Coating room from the intermediate store area by using the trolley.
7.14.2 Load the tablets into the coating pan manually by lifting and tilting the container.
7.14.3 Transfer the coating suspension to the coating room from the solution preparation room by trolley or by solution tank.
7.14.4 Unload the coated tablets from the coating pan by using unloading assembly or manually by using SS scoops/bowls in polyethylene bag lined duly labeled containers.
7.14.5 Then send the intimation slip to QA for sampling and bulk approval.
7.14.6 After QA approval, Check the coated tablets for weight and then transferred on a pallet or by using pallet trolley to the Intermediate store or to the next stage as per requirements.
7.15 Movement of material within the department: Tablet Printing if applicable,
7.15.1 Transfer the Coated tablets requiring printing by using a trolley to the printing room.
7.15.2 Load the Coated tablets into the Tablet printing machine hopper using SS scoops/bowl and collect the printed tablets in polyethylene bag lined duly labeled containers.
7.15.3 Transfer the printed tablets by using a trolley to the Intermediate store or to the next stage as per requirements.
7.16 Movement of material within the department: Capsule Filling
7.16.1 Transfer The EHG capsules from Staging or from the Intermediate storeroom to the respective capsules filling room by using the trolley.
7.16.2 Transfer the blended granules/pellets/tablets from Staging or from the Intermediate storeroom to the respective capsules filling room by using the trolley.
7.16.3 Blended granules/pellets/tablets to be weighed before taking for capsules filling.
7.16.4 Load the blended granules/pellets/tablets / EHG capsules into the hopper manually by SS scoops/bowl on the top of the hopper of the capsules filling machine.
7.16.5 Pass the filled capsules through the line machine or collect in duly labeled polyethylene lined drums/containers. And later it passes through the line machine as per requirements.
7.16.6 During capsules filling, Perform the In-process checks in the same capsules filling the room or collect in a sample bag with a proper status label. and send it to the IPQC room for in-process checks.
7.16.7 After completion of filling, Check the capsules for weight by production and then transferred by using a trolley to the Intermediate store or to the next stage as per requirements.
7.16.8 Transfer all residual recovery after completion of capsules filling, transfer to the granulation department, after taking a recovery receipt.
7.16.9 Keep the recovery granules in polyethylene bag lined duly labeled container, quantity returned should also be mentioned on the label which is duly received by the production supervisor and is kept at the designated place.
7.17 Movement of material within the department: Visual inspection
7.17.1 Transfer the Tablets / Capsules requiring inspection by using a trolley to the Inspection room.
7.17.2 Transfer the Tablets / Capsules manually using SS scoops/bowls to the hopper of the inspection belt.
7.17.3 Inspect Tablets / Capsules on Inspection try.
7.17.4 After inspection Tablets / Capsules. Collect in polyethylene bag lined duly labeled containers.
7.17.5 Inspect each container of the particular batch/very specific container.
7.17.6 Intimate QA to carry out inspection of bulk material and wait for the approval.
7.17.7 After QA approval, Inspected Tablets / Capsules shall be checked for weight and then transferred on a pallet or by using pallet trolley to the Intermediate store or to the next stage as per BMR.
7.18 Movement of material within the department: Metal Detection
7.18.1 Transfer uncoated tablets or Coated tablets or Capsules requiring metal detection by using a trolley to the Metal detection room.
7.18.2 Load the tablets/capsules into the inlet chute of Metal detector using SS scoops / bowl and the detected good tablets/capsules shall be collected from outlet chute of the machine in polyethylene bag lined duly labeled container.
7.18.3 After metal detection, Check the Tablets / Capsules for weight and then transferred by using a trolley to the Intermediate store or to the next stage as per requirements.
7.19 Movement of materials to Intermediate Store:
7.19.1 After completion of a batch at the granulation stage. It should be transferred to the respective Intermediate store and should be recorded in the Quarantine Register of Granulation Dept.
7.19.2 After completion of the batch at the compression/coating stage. The batches should be transferred to the respective Intermediate store and should be recorded in the Quarantine Register of Compression / Coating Dept.
7.19.3 Then complete the finished product BMR and handed over to QA for BMR review.
7.19.4 Then check the BMR by the concerned QA supervisor. In case of any discrepancies/improper filling of BMR, found the findings have to be completed by the production supervisor.
7.19.5 In case the batch is not approved due to some defect the batch has to be reinspected, reworked and approved by QA before packing.
7.20 Movement of materials for Packaging Operations:
7.20.1 When the product/ batch is planned for packing. Transfer the entire batch to the packing quarantine area through the lift.
7.20.2 Prior to transferring the product ( containers) to the packing department. Check the product is closed with double polybag and polybags are tightly closed with tags and labels.
7.20.3 Check the containers are closed properly with a lid.
7.20.4 Make the entry of product, batch number and no. of containers in the logbook.
7.20.5 Ensure proper segregation of products according to the product-wise / batch-wise to avoid any mix-up.
7.20.6 The batch can transfer to packing either whole quantity or partial quantity depending upon packing planning.
7.20.7 Prior to transfer the product, check all the containers are properly closed and labeled.
7.20.8 Prior to transferring the product in the primary area. Clean the containers with the help of vacuum cleaner/ lint-free cloth.
7.20.9 Prior to transferring the containers in primary packing cubicle. Ensure the cleaning of product containers are cleaned in material movement airlock.
7.21 Transfer of material from Warehouse to the Manufacturing Department:
7.21.1 Check all dispensed containers label before the transfer of materials to manufacturing.
7.21.2 Dispensed materials are transferred to the manufacturing area by using the trolley as per requirements.
7.22 Transfer of material from the Manufacturing Department to the Warehouse :
7.22.1 Check the leftover materials or materials that remained after the change in the production plan of a particular batch.
7.22.2 Transfer all the materials to HDPE container and affix quarantine label as per materials returns note.
7.22.3 Intimate warehouse and then transfer the materials on pallets placed on pallet truck/trolley along with material return note.
7.23 Transfer of material from the Manufacturing Department to the BSR:
7.23.1 Check the materials of a particular batch, which shall be transferred to BSR.
7.23.2 Make ‘Material Transfer Note’ and affix Product label.
7.23.3 Intimate QA dept. and crosschecks all the container weight against BMR.
7.23.4 After weight checks, shrink wrap the HDPE container.
7.23.5 Transfer the materials to the BSR by using trolley along with material transfer notes and BMR.
8.2 Quality Assurance
9.1 Annexure 1: Material Movement Flow Chart