To lay down the procedure for Packing of Tablets/Capsules in strip pack or blister pack as primary packing & packing of strips or blisters in cartons, shipper as secondary packing.
This SOP shall be applicable for all the primary & secondary packing operations in Packing area at Production department.
3.1 Execution : Operator
3.2 Checking : Production Pharmacist & Above
HOD-Production / Assigned Designee
5.1 PRIMARY PACKING
5.1.1 Ensure that primary packing area is cleaned & free from any leftover of previous product / batch.
5.1.2 Note down the temperature and humidity in the primary packing area.
5.1.3 Bring the dispensed quantity of foil from Tablet store II room for the respective batch.
5.1.4 Set the strip packing or blister packing machines for the required product to be packed.
5.1.5 Ensure that the area is certified by QA person according to the standard operating procedure for line clearance.
5.1.6 Receive the overprinting stereos from the Pharmacist & set the overprinting matter on overprinting unit.
5.1.7 The Pharmacist should refer the Batch Packing Record for Manufacturing Date, Expiry Date. For Retail Price, refer the price list issued from Q.A. while giving the overprinting instructions to the operator & in process checks. The latest version of authorized price list should be referred during printing.
5.1.8 Take the containers of the product to the area. Ensure and Check status label on containers for correct product name, B.No., container nos. etc & release status of the batch. Check that the tablets are inspected. Use the product containers serially as per the container numbers on the label.
5.1.9 Start the strip / blister packing machine after appropriate settings of m/c. for required temp., speed, etc.
5.1.10 Perform the initial leak testing with No. of Strips / blisters indicated in the batch record & record the results. If leak test and other parameter is satisfactory, Continue the packing process.
5.1.11 At initial stage, open few initial strips & observes the tablets for appearance of tablets change in color shade, change in branding quality, physical defect of tablets etc. if any. Also check the strips/blisters for appearance, printing clarity, cut pocket, vertical as well as horizontal cutting etc.
5.1.12 In case of collator machine, whenever the machine is stopped in between & again started, strips/blister should to be checked for correct number of tablets in each strip, cut pocket etc.
5.2 BLISTER /STRIP CHECKING DURING PACKING
5.2.1 Strip checking person should inspect for empty pocket, and pocket cut, half broken tablet (in case of blister) and remove defective strip or blister if any.
5.2.2 The person should check the printing for clarity and smudging and appearance of strip and remove defective strip or blister if any.
5.2.3 Checking person should collect the defective strip or blister in a duly label container as “Rejected”.
5.2.4 The counting person should count the required no. of blister, and send it to carton filling person.
5.3 SECONDARY PACKING
5.3.1 Before starting of the batch, line clearance of packing belt and area should be carried out.
5.3.2 Previously overprinted packing material should be ready near the packing belt.
5.3.3 Packing pharmacist should display Details of B.No. Mode of Packing, M.R.P., Mfg. /Exp. Etc. on the agminated/status label display board for status of packing operation by referring the BPR.
5.3.4 Carton filling person should check the carton for over printing, intactness; He/she should open the carton and insert the leaflet if required with counted strips.
5.3.5 Carton closing person should close the carton and arrange the carton for weighing.
5.3.6 Carton weighing person should carry out the weighing of individual cartons. He/she will check the carton against the weighing range. If he/she found any variation beyond the range, he/she will keep it aside for checking & inform the pharmacist for verification.
5.3.7 The weight of every carton is to be done. The weighed carton will be packed in shipper by shipper packing person. He/she will arrange the carton in layer and then fill it in box, till the required configuration is achieved.
5.3.8 A specimen for stenciling required to be done on shipper should be prepared & checked by stenciling operator & then authorized by Pharmacist, Approved QA person. After the approval, shipper should be stenciled. Signed specimen to be attached with respective BPR.
5.3.9 After filling the Box, the Box will be sealed and labeled. The sealed boxes will be weighed and weight will be recorded in a “Shipper weighing Record”.
5.3.10 Collect all rejected strips/blisters in an appropriately labeled container till such strips/blisters are defoiled. All defoiled tablets to be inspected for any broken tablets or tablets with damaged appearance & pieces of foil. All broken, chipped, capped tablets are kept as utilizable residue.
5.3.11 After complete inspection of tablets at the end of the batch, Pharmacist should check the good tablets and then these tablets can be repacked if required and mentioned it in the BPR as defoiled tablet packed.
5.3.12 After filling the specified quantity of cartons in to shipper, shipper packing person, Pharmacist should sign the checking slip. The checking slip will have details of Product Name, Qty., B.No. Box No., Checked by, Packed by etc.
5.3.13 The signed checking slip will be pasted inside the shipper flap & then the line leader should sign the pasted checking slip.
5.3.14 Shipper should be sealed with ‘BOPP’ tape issued for the batch.
5.3.15 Finished goods should be transferred to BSR with a note in prescribed “Finished goods transfer note”.
5.3.16 Left over unused printed foil & plain foil or PVC film should be returned to stores, & should be recorded in BPR. Any other material like leftover or rejected overprinted cartons, catch covers, labels, stenciled shipper, leaflets etc. should not be returned to stores or it should be destroyed and mentioned in the reconciliation page of BPR.
5.3.17 While sending the foil rolls to stores, each roll should be cleaned with a dry lint free cloth from all sides. Approximate 1 to 2 meters of foil should be removed & destroyed. All the rolls returned from shop floor should be wrapped in a poly bag & should be duly labeled and sign.
5.3.18 Non-recoverable product residue should be disposed off by putting it to the water as in process waste. Utilisable residue generates if any should be kept with proper label & sign of pharmacist and competent staff.
5.3.19 Disposal of overprinting stereos should be done by cutting & then further disposal.
5.3.20 Reconciliation of product, packing material & finished goods should be done in the batch documents after completion of packing.
5.3.21 Batch manufacturing record completed in all respects should be submitted to Q.A. for release of the batch for further process.
6.1 SOP: Standard Operating Procedure
6.2 BPR: Batch Packing Record
6.3 Q.A.: Quality Assurance
6.4 HOD: Head of The Department
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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