SOP of Handling of Raw & Packaging Materials under Re-Test due

SOP of 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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