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SOP for Acceptable Quality Level sampling for Tablets and capsule

  • 1.0 OBJECTIVE:To lay down a Standard Operating Procedure for Acceptable Quality Level sampling for Tablets and capsule

    2.0 SCOPE:

    This procedure shall apply to formulation plant of Pharmaceutical Company  that manufacture, package, test, and store or distribute drug products.

    3.0 RESPONSIBILITY:

    • All concerned personnel shall responsible to follow the procedure mention in this SOP.
    • Concerned Department Heads shall be responsible for compliance of the procedure.

    4.0 ACCOUNTABILITY:

    Production and QA Head shall be accountable that this SOP is implemented as per laid down procedure.

    5.0 ATTACHMENTS:

    – Attachment – I

    – Attachment – II

    – Attachment – III

    6.0 PROCEDURE:

    7.0 REFERENCES:

    ISO 2859-1:1999

    8.0 ABBREVIATIONS:

    SOP: Standard Operation Procedure

    9.0 DISTRIBBUTION LIST:

    Quality Assurance

    Human Resource and administration

    Production

    Quality Control

    Warehouse

    Engineering

    Purchase

    10.0 HISTORY OF REVISION:

    Version No. Effective Date Reason for revision
         

 

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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