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SOP on Disposal of Non-Recoverable Inprocess Materials

  • Objective:To lay down a procedure for disposal of non-recoverable in-process materials.
  • Scope:The standard operating procedure is applicable for formulation plant of Pharmaceutical Company name with location.
  • Responsibility
    • Production-Supervisor / Officer shall be responsible for implementation of this SOP.
    • Production-Head / designee shall be responsible for compliance of this SOP.
  • Abbreviations and Definitions

SOP –  Standard Operating Procedure

PVC – Polyvinyl Chloride

ETP – Effluent Treatment Plant

SS- Stainless Steel

QA – Quality Assurance

  • Procedure
    • Procedure in various manufacturing sections.
      • Rejected non-recoverable in-process products shall be destroyed by dispersing / dissolving in sufficient quantity of potable water (not less than 2 times the material volume) in a SS or PVC container labeled with ‘SCRAP’ and then transferring to ETP area.
      • Disposal of rejected tablets / capsules: Rejected tablets and capsules during the initial run from compression machine and capsule machine respectively, or from any non-conformance necessitating rejection, shall be destroyed as per the point no. 5.1.1.
      • Disposal of rejected ointment / gel / oral liquids: Rejected ointment / gel during the initial run from filling machines or from any non-conformance necessitating rejection, shall be destroyed as per point no. 5.1.1. For oral liquids, this shall be collected in SS container labeled with ‘SCRAP’ and shall be drained to ETP connected drains.
      • Disposal of dust: Dust collected from vacuum cleaner / dust extractor is destroyed as per point no. 5.1.1.
    • Procedure in various Packaging Sections.
      • Remove the Tablets / Capsules from the rejected Blisters / strips, defoil the strips / Blisters and destroy the same as per point 5.1.1
    • Forms and Records

Not Applicable

  • Distribution
    • Master Copy –  Documentation Cell (QA)
    • Controlled Copies ­– Production, Quality Assurance, Administration and Housekeeping
  • History
Date Revision Number Reason for revision
              – 00 New SOP

 

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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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