SOP for the stability of pharmaceutical products

  • Objective: To lay down a procedure to define the procedure for the stability of pharmaceutical products .
  • Scope: This Standard Operating Procedure is applicable for stability of Pharmaceuticals Product.
  • 2.0 SCOPE:This procedure shall apply to formulation plant of Pharmaceutical Company3.0 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:

    QC 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
         

 

A 9 -

A 7 -

A 8 -

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