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SOP on Procedure of Packaging Lines Control

  • Objective:To lay down a procedure for packaging lines control.
  • Scope:This Standard Operating Procedure is applicable for formulation plant of Pharmaceutical company name with location.
  • Responsibility
    • Production Supervisor / Officer shall be responsible for implementation of the procedure as per this SOP.
    • Head, Production shall be responsible for compliance of procedure as per SOP.
  • Abbreviations and Definitions

ROPP – Roll on Pilfer Proof

  • Procedure
    • For Tablets / Capsules- Packing Lines Control.
      • Ensure the ‘CLEANED’ status label and line clearance before starting new batch / product.
      • batch shall be released from Quality Control for packaging and ‘BATCH IN PROCESS’ status labels shall be affixed on the machine.
      • All packing materials like Aluminium foils, Cartons, Packaging inserts, Corrugated Boxes etc. shall be available on line according to the packaging order of the respective batch.
      • The tablets or capsules drums / containers of the respective batch with proper identification shall be available on line and tightly closed.
      • Ensure that the checking of the strips are as per norms (e.g.batch printing, pocket punctures, defected tablets / capsules etc.)
      • Quantities of strips, packaging insert and 100% of tablets / capsules in strips and 100% strip in each carton shall be checked randomly. Beside this, each packed carton shall be weighed on a suitable balance and if any deviation from the standard weight limits allowed, that particular carton shall be reviewed and checked completely.
    • For Liquid Orals- Packing Lines Control.
      • Ensure the ‘CLEANED’ status label and line clearance before starting new batch / product.
      • batch shall be released from Quality Control for packaging and ‘BATCH IN PROCESS’ status labels on all machines / area shall be affixed.
      • All packing materials like glass bottles / cartons / labels / packaging insert / ROPP caps / measuring cups / corrugated boxes shall be available on line according to packaging order of the respective batch.
      • All filling machine, sealing machine, labeling machine and transfer pump shall be cleaned.
      • The liquid syrup shall be filtered, clear and suspensions free from foreign particles.
    • For Gel / Ointment- Packing Lines Control.
      • Ensure the ‘CLEANED’ status label and line clearance before starting new batch / product.
      • batch shall be released from Quality Control for packaging and ‘BATCH IN PROCESS’ status labels on all machines / area shall be affixed.
      • All the packing materials like Lami Tubes / Cartons / Duplex Cartons / Corrugated Boxes and Packaging Insert shall be available on line according to packaging order of respective batch.
      • Bulk of the respective batch with proper identification and containers with number shall be available on line and shall be tightly closed.
      • Before filling the Ointment/Gel in filling machine hopper, machine shall be ensure for its cleanliness.
      • While filling the Ointment / Gel in the tubes care shall be exercised that the hopper shall be filled only up to capacity. This shall be confirmed by Production.
      • Every time the hopper shall be charged, the lid shall be replaced on the hopper.
    • All the rejected packs e.g. strips, bottles, tubes due to improper printing / labeling / batch coding or defective content (e.g. presence of defective tablets in the cases of strips, less volume or less weight in the cases of liquid and ointment) shall be opened in presence of IPQA and production supervisor / officer, in the primary packaging area with required environmental conditions.
    • All strips shall be counted and handed over for defoiling and quantities shall be counter checked by IPQA and Packaging supervisor / officer. Record the activity in the annexure-1.
    • Good content e.g. tablet / capsule / liquid or ointment shall be used for repacking or refilling alongwith its parent batch.
    • Atleast one person from production staff shall be present in the packing hall during working hours including breaks.
  • Forms and Records
    • Rejected Strips Handing over for Defoiling – Annexure-1
  • Distribution
    • Master Copy –           Documentation Cell (QA)
    • Controlled Copies –           Production, Quality Assurance and Quality Control
  • History
Date Revision Number Reason of Revision
00 New SOP

Annexure-1

Product:

Batch No.

Machine Name:

                           REJECTED STRIPS HANDING OVER FOR DEFOILING

Date Time No. of  Strips sent for defoiling Checked by Production Checked by IPQA

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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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