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 DateReason for revision
       

 

A 9 -

A 7 -

A 8 -