Follow
Objective
To ensure adequate process control at every stage-Receipt of materials, Manufacturing and Packing so as to get the Drug Product (Finished Product) as per required specification.
Scope
This procedure is applicable to all Production activities such as Manufacturing, Packing (Tablet & Capsule) and warehouse department at (Company Name).
Responsibility
3.1 IPQA officer shall be responsible for sampling and performing the activity as per procedure.
3.2 QA In-charge shall be responsible to ensure proper and timely execution.
3.3 Manager QA shall be responsible for effective implementation and training.
Accountability
4.1 Head of Quality.
Precautions
Not applicable
Procedure
6.1 General Instructions.
6.1.1 Check the general environment in the department.
6.1.2 Ensure proper gowning by the personnel in concerned work area.
6.1.3 Check the calibration status label of machines.
6.1.4 Ensure that the line clearance is obtained before starting the next step.
6.1.5 Ensure the destruction of all In-process, rejects, and excess overprinted packing material and rubber stereos after packing.
6.1.6 Ensure that the every stage of process, appropriate status label is affixed on equipment/machines and containers.
6.1.7 Non compliance shall be reported immediately to concerned department head.
6.1.8 Ensure the completion of documentation at the end of each processing stage.
6.2 Dispensing – Raw Material.
6.2.1 Ensure line clearance before commencement of dispensing activity.
6.2.2 Ensure all the material having properly labeled.
6.2.3 Ensure that only “Quarantine” material is stored in quarantine area.
6.2.4 Ensure the transfer of Approved material in “Approved Area”.
6.2.5 Ensure that storage conditions of raw material are met.
6.2.6 Ensure the following points on Approved Quality Control labels.
6.2.6.1 Analytical Report Number.
6.2.6.2 Re-test date
6.2.6.3 Ensure that the loose containers are properly closed after dispensing.
6.2.6.4 Ensure that the material is issued on FEFO / FIFO basis.
6.2.6.5 Ensure that the environmental conditions are maintained in the respective areas.
6.2.6.6 Ensure that the details on dispensed material, material issues slip/dispensing slip are matching with Material Issuance form.
6.3 Dispensing – Packaging Material
6.3.1 Ensure proper segregation of materials.
6.3.2 Ensure proper disposal of the rejected items.
6.3.3 Ensure that the material is issued on First in First out (FIFO) basis.
6.3.4 Ensure the accuracy of artwork code on printed packing materials.
6.4 Warehouse Finished (drug) product
6.4.1 Ensure that the products are dispatched only after QA release.
6.4.2 Ensure the proper storage of goods.
6.4.3 Ensure that “Quarantine “drug product are stored in quarantine area of Warehouse drug product.
6.5 Production Department
6.5.1 Ensure line clearance before commencement of each operation and fill the line clearance details in Batch Production Record (Manufacturing & Packing)
6.5.2 Ensure the process status labels affixed on equipment / machines are appropriate to the stages.
6.5.3 Ensure the temperature, humidity and pressure differential in capsule filling/tablet Compression, Inspection and Pkg. areas are within limit.
6.5.4 Check the material weight sieve integrity, size and labels for raw materials as per Batch production record. (BMR & BPR).
6.5.5 Check on line capsule filling, tablet compression and packing process at the start of the batch and suitable interval, each time after every break.
6.5.6 Checks on line compressed tablets and filled capsules for physical parameters, uniformity of weights (Weight variation) and record the observation in the Batch production record.
6.5.7 Ensure set parameters during coating as per Batch production record and check physical parameters of coated tablets, uniformity of weights, weight gain, Disintegration Time and record the observation in Batch production record.
6.5.8 Check the leak test of Blisters/bottles and record the observations in Batch production record. If leak test complies, (not single stock tablet/capsule should fail in leak test) run the machine. If leak test does not comply stop the machine immediately and check the leak test of the blisters/bottles of consecutive previous shippers until the leak test found satisfactory. If leak test fails defoil all the blisters or repack all the bottles of the observed shipper/shippers. After checking the previous shippers, rectify the problem and perform the leak test again. Run the machine only if all the blisters pass the leak test. Record the leak test result in the operation log book and in the BPR.
6.5.9 Verify the first pack (Shipper) for every batch and record the observations in Batch production record.
6.5.10 If any of the tests fails to the specification, inform Head of department for corrective action.
6.5.11 Randomly check the final pack (shipper) for correct details for – Name of the Product, Quantity, Batch no., Mfg. Date, Exp. Date, Box no.,Pkd. By and weights.
6.5.12 Randomly open the box by removing BOPP (Biaxially Oriented Polypropylene) tape and check physical quantity of inner shipper, cartons as per specifications. Always check the last box.
6.5.13 Check randomly one inner shipper and final pack cartons for correct details as given Below.
6.5.14 For carton and catch cover, check following details – Batch no, Mfg. date, Expiry date, Mfg. Lic. No., P.S.for Sample packs for accuracy and legibility.
6.5.15 For Strips / Blisters/ Bottles, check following details – Mfg. date, Expiry date, Batch no., Mfg. Lic. No for accuracy and legibility.
6.5.16 Ensure presence of specified no of Tablets / Capsules in each Strip / Blister/Bottle/Pouch pack.
6.5.17 During bottle filling ensure the cleanliness of bottle (after air washing) prior to filling and bottle sealing quality.
6.5.18 Ensure cleanliness of the pouch pack visually and pouch sealing quality.
6.5.19 Ensure absence of any defect likes broken tablet, empty pocket, pinholes, damaged Capsules, black spots etc.
6.5.20 Check the contents of units for all relevant items including leaflets /insert if present.
6.5.21 Check the part box if filled at the end of batch for its quantity, labeling details and sign on “loose box” label and record the details in Batch production record.
6.5.22 Randomly collect the samples for analysis and control, enter the quantity in respective BPR after completion of batch and forward to Quality control department.
