SOP for Re-analysis of Raw Material | Pharmaguideline
  •   Pharmaguideline Courses Start Learning
  • Apr 17, 2021

    SOP for Re-analysis of Raw Material

    Standard operating procedure to re-analyze and record the raw material after the retest date.

    1.0 OBJECTIVE

    To lay down the procedure for reanalysis of raw material.

    2.0 SCOPE

    This SOP shall be applicable to Quality Control Dept.

    3.0 RESPONSIBILITY

    Supervisor Quality Control

    4.0 ACCOUNTABILITY

    Sr. Manager Quality Assurance

    5.0 PROCEDURE

    5.1 All active and inactive materials shall be reanalyzed as per following schedule.
    i) Enzymes 6 months ii) Active 12 months iii) Inactive 24 months
    5.2 Stores personnel shall inform the material due for retesting every month to Quality Control.
    5.3 The quality control shall move the Material to the UNDERTEST area and shall Sample the material. Containers shall be labeled as "UNDERTEST".
    5.4 Complete checks as per Specifications shall be carried out.
    5.5 If Material is found to be complying to Specifications, the “APPROVED” slip showing new assigned control number shall be posted on the containers, and material shall be moved to the designated storage area.
    5.6 Sampling sheet and analytical report shall be prepared.
    Related: SOP for Sampling of Raw Material

    5.7 Record

    An Entry register shall be maintained, and each material re-analyzed shall be entered therein. A fresh Control Number shall be allotted to the reanalyzed material. A report showing test protocol applied and results obtained shall be prepared.

    6.0 ABBREVIATION

    6.1 SOP: Standard Operating Procedure
    Get editable documentsView List

    No comments:

    Post a Comment

    Please don't spam. Comments having links would not be published.


    Popular Categories ๐Ÿท️

    QA SOPs QC SOPs Micro SOPs HVAC Production SOPs Stores SOPs Checklists Maintenance SOPs HPLC Sterile GLP Validation Protocols Water System GDP Regulatory Maintenance Calibration Warning Letters Education B.Pharmacy
    Online Courses Salary Calculator
    Follow on Whatsapp


    Certificate Courses ๐ŸŽ–️

    Pharmaceutical Courses

    Follow Pharmaguideline


    DOCUMENTS ๐Ÿ“‹

    PHARMACEUTICAL DOCUMENTS




    Editable Pharmaceutical Documents in MS-Word Format. Ready to use SOPs, Protocols, Master Plans, Manuals and more...

    View


    adsbypg


    GET APP FOR NEWS UPDATES


    Android App