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In-process checks during Packaging Operation of tablets and capsules

  • In-process checks during Packaging Operation of tablets and capsules
  • OBJECTIVE :To lay down the procedure for in-process checks during packaging operation of tablets and capsules.
  • RESPONSIBILITY :
  • Officer-Production Packaging.
  • Head of Production Department.
  • Officer-Quality Assurance
  • Head of Quality Assurance Department to ensure compliance.
  • PROCEDURE:
  • Inspection of Packaging Materials :
  • Production Officer and QA-Officer shall check that the packaging components issued  (containers, closures, foils  etc.,)  are  as  per  the  Production  Order -Packaging Materials and also check that materials issued are approved by Quality Control.
  • QA-Officer  along-with  Production  Packaging Officer shall check the printed text  matter  on  all  printed  components  as  per  requirement  and  attach a specimen  of  the  printed  component  to  the  respective  Batch Production Record (BPR).
  • In-process Checks during Blister Packing Operation :
  • QA-Officer shall ensure that the correct product of a specific Batch No. of tablets/capsules is brought to the blister packing  room  and is approved by Quality Control.
  • QA-Officer shall ensure that the ‘Product Label’ is filled and displayed on the machine.
  • QA – Officer  shall  ensure  that  the temperature and relative humidity of the blister packing room is in accordance with the manufacturing instructions, if any,  on the BPR.
  • QA Officer  and  Production Officer  shall  check  for  the  clarity of the coded/embossed details on the foil, as per the requirement  with  respect  to Batch No.,expiry date  etc., If the coding  is  correct  QA Officer  and  Production Officer shall  sign  on coded foil and attach the signed foil to the BPR.
  • Any printing on the tablet surface prior to packaging shall also be checked by QA Officer.
  • Production Officer and QA Officer shall independently perform the Leak  test on 10 continuous  blister  packs  taken  after  the  machine is set or after the machine  is  stopped  and restarted or after any adjustments are made in the machine.
  • QA Officer and Production officer shall independently inspect 10 continuous blister packs at about every 1 hour interval  for  the  following  and  record the observations in the ‘In-process checks during Blister/Bulk Packing Operation’.
  • Lactobacillus Sporogenes (drugsformulations.com)

  • Coding details
  • Knurling on blisters
  • Blister formation
  • Cutting edges of blisters
  • Punctured pockets
  • Ink lifting on foils
  • Scratch marks and spots on strips
  • Chipped/capped/broken tablets
  • Defective tablets/capsules.
  • Others
  • In-process checks during Packaging Operation  of blister strips :
  • QA-Officer shall ensure that the details of the Packaging Operation on-line is written and displayed on the board adjacent to the line.
  • QA Officer and Production Officer shall check that the coding details entered on  the  blister  foils  match  with the details entered on other coded materials such as cartons, shipper labels etc., and with the details on the BPR.
  • QA Officer and Production officer shall independently inspect the first few packed units on-line and then at regular  intervals of one hour for
  • Any visible defects on strips.
  • Coding details on unit cartons
  • outer cartons, shipper labels etc.,
  • Quantity in unit cartons and outer cartons.
  • Arrangement is compact without any gaps or rattling
  • Packaging components including pads, partitions, literature etc., and their arrangement. (whichever is applicable).
  • Sealing of polybags (if applicable).
  • Placing of desiccants (if any).
  • Irregular labeling on unit cartons and shippers.
  • Ensure that the rejected strips are stored in suitable containers, in specified storage conditions and labeled with batch details.
  • In case  blister  packing  and   secondary   packing   operations   are  done simultaneously, both the activities shall be monitored by single inspection.
  • In-process checks during Bulk Packing of tablets :
  • QA-Officer shall ensure that the correct product of a specific Batch No. of tablets/capsules is brought to the Bulk packing room and  is approved by Quality Control.
  • QA-Officer shall ensure that the ‘Product Label’ is filled and displayed on the machine.
  • QA  Officer  shall  ensure  that  the  temperature and relative humidity of the bulk packing room is in accordance to the manufacturing instructions, if any,on the BPR.
  • Ensure cleanliness of empty containers for absence of dust, any denting,colour, black spots or any extraneous matter.
  • QA Officer and Production Officer shall independently  inspect 2 to 5 bottles at 1 hour  interval for the following and record the observations in the ‘In-process checks during Blister/Bulk Packing  operation’.
  • Coded details on the label of bottles ,
  • Packing components like cotton coil, desiccant, literature, etc.
  • Quantity of tablets/capsules by weight and by count.
  • Defective tablets/capsules.
  • QA Officer  and  Production Officer  shall  check  for  the  clarity of the coded/embossed details on the bottle label, as per  the  requirement  with  respect to Batch No., expiry date  etc., If  the  coding  is  correct  QA Officer  and Production Officer  shall  sign  on coded label and attach the signed label to the BPR.
  • Production  Officer  and  QA  Officer shall  independently perform the torque test on 2 to 5 containers taken after the  machine is set or after the machine is stopped and restarted or after any  adjustments made on the machine.
  • In case any defect or discrepancy is observed, QA-Officer shall inform the Production Officer and ensure that the defect is rectified.
  • After an observed defect is rectified, QA Officer shall ensure that packed units collected  before  the defect was observed and after the defect is rectified, are free from defects.
  • QA-Officer shall collect Finished Product samples,  Reserve Samples, Stability Samples and samples for Bio-availability studies whenever required of packed products as per the respective SOPs and enter the quantities respectively on the “In-process Checks during Blister/Bulk Packing Operation”.
  • After completion of Packaging operation for a batch of tablets/capsules, the format of ‘In-process checks during Blister/Bulk packing operation’ shall be filed in the corresponding Batch Production Record
  • Forms and Records
    • NA
  • Distribution
    • Master Copy – Documentation Cell (Quality Assurance)
    • Controlled Copies – Quality Control, Production, Stores, Engineering
  • History
Date Revision Number Reason for Revision
00 New SOP

Glucosamine Sulphate (drugsformulations.com)

 

 

 

 

About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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