1.0 Objective: To lay down a procedure for the movement of material from one stage to another.
2.0 Scope: This procedure is applicable for the movement of material from one stage to another stage during various processes in the production department.
3.0 Responsibility:
Operator, Officer, and Executive – Production Department
Manager – Production Department
4.0 Definitions:
NA
5.0 Procedure:
5.1 Store to Dispensed Material Hold
5.1.1 Individual material shall be dispensed using clean individual SS scoops. Solvents shall be pumped from the solvent store into a stainless steel container.
5.1.2 During dispensing, raw material shall be transferred carefully from intact containers to double polybags using clean individual SS steel scoops.
5.1.3 The weight of the dispensed material shall be cheeked on a pre-calibrated weighing balance.
5.1.4 Remove the polybag from the weighing balance platform and tie the mouth of the inner polybag properly with a fastener. Place RM status label in between two polybags. Place another Raw material status label in the fastener and tie the outer polybag with it.
5.1.5 Transfer the dispensed material to the Dispensed Material Hold area.
5.1.6 Record the observations in respective BMR.
Note: 1. Place all the materials on the SS pallet only.
5.1.7 Before dispensing ensure that the ‘RELEASED’ label is affixed to the container/bags.
5.1.8 Ensure the nomenclature and specifications on RM bag/container are as per respective BMR.
5.2 Dispensed material hold to Day’s store / Coating Material Hold
5.2.1 Collect and crosscheck the weight of dispensed materials per respective BMR in Day’s Store area/coating material hold.
5.3 Days Store to Granulation
5.3.1 Transfer raw material into the granulation area.
5.3.2 Check the sieve number and integrity before setting it on the vibratory sifter.
5.3.3 During sifting, the material shall be transferred to the sifter manually with stainless steel scoops.
5.3.4 Bear elbow-length hand gloves during the sifting operation.
5.3.5 Collect the sifted material in a pre-labeled SS container lined with double polybags.
5.4 Loading into Paste Preparation Kettle
5.4.1 Transfer the binder in the sequence, mentioned in the respective BMR into the paste preparation kettle with an SS scoop / calibrated SS jar.
5.5 Loading in Rapid mixer granulator
5.5.1 Sifted raw material shall be to the RMG with the SS scoop.
5.5.2 Transfer the binder solution into the dry mixed material as per instruction and stage of operation mentioned in the respective BMR with calibrated SS jar.
5.5.3 If required, add a measured quantity of additional purified water or solvent.
5.6 Rapid mixer granulator to FBD Bowl for drying
5.6.1 Wet granules are to be unloaded directly into the FBD bowl by placing the FBD bowl below the discharge of RMG such that the bowl sensor can sense the bowl.
5.7 FBD to a sifter and Multi mill for sizing
5.7.1 Unload the dried granules in a pre-labeled SS container lined with double polybags.
5.7.2 Bear elbow-length hand gloves during sifting operation.
5.7.3 Transfer the granules into a sifter or multi-mill with an SS scoop.
5.7.4 Collect the sifted or milled material in a pre-labeled SS container lined with double polybags.
5.8 Sized Granules for Lubrication
5.8.1 Ensure the discharge chute of the blender bin is closed.
5.8.2 Sized material and Sifted lubricants are to be loaded directly into the blender bin.
5.8.3 Before the operation, ensure that the air vent and the top lid are firmly closed
5.9 Granulation area to granules quarantine
5.9.1 Lubricated granules shall be transferred to granules quarantine in pre-labeled SS containers lined with double polybags.
Note: Granules can be kept up to 7 days in a quarantine area before the next step.
5.10 Granule Quarantine to Compression
5.10.1 Check the specifications on the status label as per the respective BMR.
5.10.2 Transfer the SS containers from granules quarantine into compression on the SS trolley.
5.10.3 Lubricated granules shall be fed into the hopper of the compression machine manually with an SS scoop to the hopper of the compression machine.
5.10.4 Collect the compressed tablets below the tablet metal detector and combo deduster in pre-labeled SS containers lined with double polybags.
5.10.5 Compressed tablet containers shall be transferred to compressed tablet quarantine.
Note 1) Uncoated tablets can be kept for up to 14 days in a quarantine area before the next step.
5.11 Compressed Tablet Quarantine
5.11.1 Ensure that approved tablets are taken for coating.
5.11.2 Cross-check the Weight of coating material with respect to respective BMR.
5.11.3 Transferred the cross-checked coating material from the coating material hold area to the coating solution preparation area.
5.11.4 Load the core tablets with an SS scoop in the pan.
5.11.5 Transferred the coating solution into the coating solution hold tank.
5.11.6 Coated tablets shall be transferred to the tablet storage area in a pre-labeled SS container lined with double polybags.
Note: Coated tablets can be kept for up to 21 days in a quarantine area before the next step.
5.12 Coating to Inspection Area
5.12.1 Transfer the approved coated / uncoated tablets/capsules to the inspection area.
5.12.2 After Inspection, transfer the tablets/capsules in a pre-labeled SS container lined with double polybags to Tablet Hold.
5.13 Tablet Hold to Blister / Strip Packing
5.13.1 Inspected tablet shall be transferred to blister/strip/bulk packing area on pallets.
5.13.2 Blister packs and strip packs shall be transferred on the conveyer belt to the packing area for packing into cartons and shippers.
5.14 Packing area to finished goods store
5.14.1 Packed goods shall be transferred to the finished goods store after completion of batch or at the end of the day by verifying by quality assurance.
5.14.2 Packed goods shall be dispatched on the requirement to the respective location after release from Quality Assurance.
Note: Entries are to be made in the Inward/Outward register as per Given SOP.
6.0 Abbreviations:
FBD: Fluidized Bed Drier.
SOP: Standard Operating Procedure
RMG : Rapid mixer Granulator
RM: Raw Material
SS: Stainless steel
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