Standard Operating Procedure of Assurance Checks During Packaging in Pharmaceuticals Plant is describe in this post.
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1. PURPOSE
To describe the assurance checks conducted during Secondary packaging of products to ensure compliance with cGMP and fabrication of quality finished products acceptable to consumer, regulatory authorities and organization.
2. SCOPE
This procedure is applicable to all packaging areas where products are being secondary packed.
3. RESPONSIBILITY
3.1 Quality Assurance Manager is responsible to check all activities performed by Q.A staff.
3.2 Quality Assurance Officers are responsible to conduct the activities during daily assurance rounds according to checks given in this SOP and verify by signing the Batch Manufacturing Record (BMR).
4. MATERIAL & EQUIPMENT
4.1 Hygrometer.
5. PROCEDURE
5.1 Check that the packaging operation is being carried out in designated packaging area of respective section, also check the sanitation conditions of the area and sign the “Sanitation Record Sheet” of Packaging Area of the respective section.
5.2 Check the temperature of the area for compliance with the area requirements.
5.3 Before packing and printing, check the equipment / belt for cleanliness and ensure that batches are QC released. Give line clearance according to the “SOP for Line Clearance” and sign BMR.
5.4 Also ensure that clean equipment status is identified.
5.5 At the start of Printing, Production Pharmacist first checks the coding and then Q.A Officer verifies the coding of cartons, bottle/Jar labels from Blisters/Ampoules & BMR and signs on one printed unit carton / label which is retained with BMR. If printing discontinued or printing done in different days then printing machine operator and production pharmacist to check the batch coding and to get it verified from Q.A Officer.
5.6 Check the operators for wearing specified & clean uniforms in compliance with cGMP.
5.7 During secondary packing of any product, following inprocess checks are carried out throughout the packaging operation and reported on “Inprocess Packing Line Record” by Production Pharmacist and Q.A Officer.
5.7.1. Cartons
a. General appearance that includes correctness of printed text, color, neatness, ink spreading or spots.
b. Correctness of coding (Batch no., Mfg. Date. Expiry Date, Price).
c. Pasting of cartons.
d. Flap locking of cartons.
5.7.2. Labels
a. General appearance that includes correctness of printed text, color, neatness, ink spreading or spots.
b. Correctness of coding (Batch no., Mfg. Date. Expiry Date, Price).
c. Proper alignment (labels applied must not be tilted).
d. Pasting of labels.
5.7.3. Leaflets
a. Presence/Printing of leaflet in each carton (where applicable).
b. General appearance that includes correctness of printed text, color, neatness, ink spreading or spots.
c. Proper folding and cutting of leaflets.
5.7.4. Caps
a. Proper crimping and folding of seal.
b. Proper cutting.
c. Logo ( if printed).
5.7.5. Glass Bottles
a. General appearance that includes neatness
b. Proper Volume of Liquid syrup/suspension
c. Proper sealing of cap
d. Logo (if Printed)
5.7.6. Plastic Bottles & Cans
a. General appearance that includes neatness
b. Proper Volume of drench/liquid
c. Proper Heat sealing
d. Proper caping
e. Logo (if Printed)
5.7.7. Blisters
a. General appearance of aluminum foil, PVC/ PVDC/ Alu Alu that includes correctness of printed text, color, neatness, ink spreading or spots.
b. Correctness of coding (Batch no., Expiry Date).
c. Proper sealing and cutting of blisters.
d. Physical appearance of Product (Tablets/Bolus/Capsules/Injection) in blisters.
5.7.8. Ampoules/Vials
a. General appearance of Ampoules that includes correctness of printed text, color, neatness, ink spreading or spots.
b. Correctness of coding (Batch no., Mfg date and Expiry Date) (in-case of Ampoules).
c. Proper sealing of Ampoules.
d. Proper stoppering of rubber stopper and sealing of flip off seal in case of Vials.
e. Volume/color variation.
f. No Fiber/Particle (Glass/Black/White).
5.7.9. Shipper
a. Number of units per shipper.
b. Flap locking of shipper.
c. Printing of text on shippers and Product Batch #, Mfg. & Exp. Dates, No. of Units per shipper, Packed by initials.
d. Coding on shippers, for Human or Veterinary.
5.7.10. Accessories
a. Presence of accessories (spoons, measures, droppers, bottle supporters etc.) in each carton (where applicable).
5.8 After completion of packing verify the destruction of leftover packing material and rejected ampoules.
5.9 Ensure that handling of wastes is being performed properly.
5.10 After the completion of Packing, Packing pharmacist to provide the completed BMR to Q.A Officer for FG sampling.
5.11 Q.A Officer performs the FG sampling as per SOP “Finished Goods sampling”.
5.12. Finish Good FG WAREHOUSE CHECKS
5.12.1 Verify that the batch is not dispatched till QC release.
5.12.2 Verify that each shipper is stamped with “Release for Dispatch” stamp after receiving of Request for Dispatch, BMR & FG report from QC.
5.12.3 Check that different products are not stacked mixed on the same pallet.
5.12.4 Check that any unidentified product is not present in FG warehouse areas.
5.13 In-case of any problem Q.A Officer informs the Production Pharmacist/ Production Manager/FG Warehouse Incharge to take immediate corrective/preventive action(s) and after that Q.A Officer verifies the effectiveness of corrective/preventive action(s).
5.14 In case of any deviation in any Department, person who witnessed raises Deviation Form as per SOP for Deviation Management and Q.A department is responsible for investigation.
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