sop for tablet packing

1.0 Objective: To describe the procedure for tablet packing.
2.0 Scope: This procedure is applicable to packing department
3.0 Responsibility: Production Officers / Executive.
4.0 Accountability: Department Head shall be accountable for the compliance of the system.
5.0 Procedure:

5.1 Planning & Scheduling of Program:
5.1.1 Prepare daily plan as per delivery schedule of planning & manufacturing department.
5.1.2 Obtain the required packaging order as per plan, well in advance of schedule.
5.1.3 Indent the stereos as per the manufacturing requisition intimation sheet & check the packaging order for correctness of the matter. Forward it to stores for issue of packaging materials.
5.2 Receipt of Packaging Material:
5.2.1 Acknowledge the receipt of materials in the packaging order, return one copy of the packaging order to ware house.
5.2.2 Check & transfer issued packaging material to packing department.
5.2.3 Check the following points while receiving the material: Name of the packaging material Packaging item code Released item & details Weights/quantities of packaging material as per the packing order.
5.2.4 Store supervisor has to fill the details like A.R. No., issued quantity etc. in both the copies of packaging order.
5.3 Issue of Bulk:
5.3.1 After releasing of semi bulk by Q.A. for packing, the entire batch of the product is to be weighed, checked & transferred to the Packaging section.
5.3.2 Manufacturing chemist will issue the bulk slip, sign by production person in transfer by and packing person in received by column.
5.4 Start Up of the Packaging Line:
5.4.1 Packaging personnel & QA personnel should ensure that the packaging equipments are in the closed condition before use for any operation.
5.4.2 Ensure the cleanliness of the surrounding area.
5.4.3 Ensure the absence of any materials or remainants of the previous product in the machine or in the area.
5.4.4 Arrange the workmen on packing operation, as per the configuration requirement.
5.4.5 Display the indicating board having the following details: Product Name Batch Size Batch No Status Mfg Date Exp Date

5.4.6 Ensure that the machine room conditions comply with predefined temperature,
humidity & differential pressure required for the product under packaging.
5.4.6 Ensure that each equipment which is to be used for packaging procedure must be ‘CLEANED’.
5.5 Machine-Line Clearance:
5.5.1 Fill the applicable machine line clearance form & inform the QA dept. for line clearance.
5.5.2 After the line clearance transfer the bulk product of the particular batch duly passed by Q.A. to packaging machine room.
5.6 Machine Operating –Start Up of Line:
5.6.1 Follow relevant SOP for assembling & operation of the machine.
5.6.2 Bring the entire primary packaging material mentioned in the packaging order & store it in the enter room on the pallet.
5.6.3 Check the correctness of the following over coding details of the printed material: Batch No., Mfg. Date, Exp. Date. Price details, Mfg. Lic. No. Additional details if any
5.6.4 Attach the certified coded material specimen copy in the specimen sheet & attach it with BPR and then run the machine.
5.6.5 Record the room conditions in the log sheet.
5.6.6 Check the initial five packs for the correctness of the following: Quantity mentioned on packs Appearance
5.6.7 If these preliminary checks are satisfactory, carry out the packing of the product.
5.7 In-Process Checks: (Frequency: at the starting of the line & every hour thereafter)
5.8 Machine Line Closing:
5.8.1 Clean the machine, packing line & in-process equipment.
5.8.2 Reconcile the document.
5.8.3 Un-coded material should be returned to stores with a return note.
5.8.4 Rejection should be suitably destroyed in presence of a responsible person.
5.8.5 Complete the BPR & send it to QA. Transfer the packed goods to the finished goods quarantine area.
5.8.6 Return unused packing material to stores.
5.9 Equipment – Preventive Maintenance:
5.9.1 While planning production schedule, check machine idle time during the month.
5.9.2 Hand over the machine to the maintenance department for preventive maintenance as per predefined schedule.
5.10 Change Part List & Inventory:
5.10.1 Arrange change parts of all the machines in cupboards & label them.
5.10.2 Check the change parts for wear / tear & damages.
5.10.3 Take corrective actions in case any damage in change parts or any defect is developed.

6.0 Abbreviations:

Abbreviation Expanded Form
QA Quality Assurance
SOP Standard Operating Procedure
PR Production
NA Not Applicable
BPR Batch Packing Record
AR No. Analytical Report Number


7.0 Distribution List:

S. No. Department Name No. of Copy
1. Quality Assurance 01
2. Production 01


8.0 References:
In – House





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