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Handling of Raw & Packaging Materials under Re-Test due

Handling of Raw & Packaging Materials under Re-Test due

Objective:To lay down a procedure for Handling of Raw & Packaging Materials under Re-Test due.

  • Scope:This SOP is applicable to all raw & packaging materials under retest due in warehouse at (Pharmaceutical Company Name).
  • Responsibility:
    • Concerned Store personnel shall be responsible for intimating Quality control about the retest due.
    • Quality control personnel shall be responsible for analysis and approval / rejection of material under retest due.
  • Accountability:
    • Head of Concerned Department & QA shall be accountable for the implementation of this SOP.
  • Abbreviations and Definitions

SOP :   Standard Operating Procedure

QA   :   Quality Assurance

QC   :   Quality Control

  • Procedure:
    • The Warehouse personnel shall check the materials under re-test dates given by QC on the GRN & record the Re-Test in Re-Test Material Verification Record, Annexure – I.
    • The warehouse personnel shall raise the Re-Test request of Raw & Packaging Material with existing stock along with the actual receipt quantity & GRN No. to QC for sampling the material(s).
    • The container(s) / pack(s) of the material shall be transferred to the respective Quarantine area affixed with “QUARANTINE” label duly filled with current available quantity for re- test & signed by warehouse personnel.
    • The previous Quarantine label along with Approved status label shall be defaced with permanent black marker pen & new Quarantine label shall be affixed nearby defaced label.
    • The material to be retested in the next month shall be verified with existing stock recorded from the Material Stock Card.
    • The Intimation / Communication for retest shall be prepared by warehouse personnel through Re-Test Request of Raw & Packaging Material refer Annexure-II. The Re-Test Request shall be send to QC on the Re-Test date mentioned in the GRN.
    • The QC personnel take the sample of the respective material & after final analysis, the “APPROVED” / “REJECTED” label as applicable shall be displayed on the container(s) / Pack(s) of the material.
    • Approved / Rejected status of materials shall be provided by Quality Control through Re-Test Request of Raw & Packaging Material Annexure-II along with respective label.
    • Warehouse personnel shall transfer the material(s) in their respective storage area as per status provided by QC.

Note: – The materials under Re-Test date (To be used within seven days) provided by QC shall only be tested at the time of requirement / production plan & not to tested time & again if Re-evaluation date of that material already passed.

  • Forms and Records
    • Re-Test Material Verification Record –  Annexure I
    • Re-Test Request of Raw & Packaging Material –  Annexure II
  • Distribution
    • Master copy – Quality Assurance
    • Controlled copies – Quality Assurance, Quality Control and Warehouse
  • History
Date Revision Number                   Reason for Revision
                      New SOP

                                                        Annexure I

Raw / Packaging Materials                             Month & Year:……………………………….

(Pls. mark tick as required)

S. No. Name of Material  GRN No. A.R.No. Re-Test Date Checked By (Sign/Date) Verified By (Sign/Date)
             

                                                       Annexure II 

Date: 

GRN No. GRN date Item Code
Invoice No. Invoice date Batch No
Material name Actual receipt Qty.
Supplier’s name Current stock qty (to be re-test)
Manufacturer’s name No. of container(s) / pack(s)
Mfg. date Exp. Date / Best before / Re-evaluation date
Existing  AR No
Analysis required as per (please tick mark as reqd.) IP  /  USP  /  BP  / EP  /  IH
Sign. Warehouse:

SAMPLER’S COMMENT

No of packs Sampled————————————-Samples Quantity—————————————

Sampled By———————————————-Sampled On———————————————–

Sampler’s Remark—————————————————————————————————–

 

QC COMMENT

AR No —————————–Release Date —————-Potency/Assay———————————-

LOD / Moisture————————————-   Approved / Rejected —————————————

Analyst Remark’s—————————————————————————————————–

Retesting due on———————————————————-

Analyzed By:                                                          Approved By:

GRN No. GRN date Item Code
Invoice No. Invoice date Batch No
Material name Actual receipt Qty.
Supplier’s name Current stock qty (to be re-test)
Manufacturer’s name No. of container(s) / pack(s)
Mfg. date Exp. Date / Best before / Re-evaluation date
Existing  AR No
Analysis required as per (please tick mark as reqd.) IP  /  USP  /  BP  / EP  /  IH
Sign. Warehouse:

 

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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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