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Code to Code Transfer of Materials and Additional Testing of Materials / Products

Code to Code Transfer of Materials

Objective (procedure)

To lay down a procedure for code transfer of same material from one code to another and to carry out additional testing of APIs, Excipients and Drug Products to comply with other specifications or Pharmacopoeia.

  • Scope

This standard operating procedure is applicable at formulation plant .

  • Responsibility
    • Officer/Executive – Stores or Store-in-charge shall be responsible for raising the Code Transfer of Material Request.
    • Officer/Executive – PDL/R&D/Production/QA shall be responsible for raising the Additional Test Request.
    • Officer/Executive-QC shall be responsible for conducting the testing as per request.
    • Concerned department Head, Designee shall be responsible for reviewing the ‘Code  Transfer of Materials Request’.
    • Head-QA /Designee shall be responsible for approving ‘Code Transfer of Materials
    • Request/ Additional Test Request’ and transfer of qty in SAP.
  • Abbreviations and Definitions

API                             :           Active Pharmaceutical Ingredient

SAP                             :           System Application and Data Processing: (Integrated software)

PDL                            :           Process Development Laboratory

R&D                           :           Research and Development

QA                               :          Quality Assurance

QC                               :            Quality Control

A.R. No.                      :          Analytical Request Number

SOP                             :           Standard Operating Procedure

Dept.                           :           Department

Additional testing   :           Testing to be performed on the API, Excipients or Finished Goods other than those mentioned in the Specifications or Pharmacopeia to comply with another specification for other markets.

  • Procedure

                    Notes:

  • Item codes which are vendor specific shall not be subjected for code to code transfer from any other codes material.
  • Item codes under re-testing shall not be referred for transfer in other codes.
    • Procedure for code transfer
      • Based on the requirement Stores shall raise a ‘Code Transfer of Materials Request/ Additional Test Request’ as per Annexure – 1 and submit to QA along with approved COA of existing code material.
      • Assigning of Requisition number of code transfer of material.
        • Number shall be assigned by Stores and log shall be maintained for the same as per Annexure-2.
        • Requisition number of Code transfer of material shall be of seven alpha-numeric characters.
        • Numbering shall follow following format CTYYZZZ, where CT stands for code transfer, YY denotes last two digits of calendar year and ZZZ denotes serial no. starting from 001, 002, 003 and so on.
      • After QA approval on code transfer for material officer, Stores shall send the request to QC for sampling and testing on ‘Code Transfer of Materials Request/ Additional Test Request’ (Annexure-1) and subsequently required qty for sample shall be updated in the SAP to generate the A. R. No. and deduction and updation of this qty. in stock ledger too.
      • Transfer of the material between the different codes of the same material having different brand or Compendial status shall be done only if it meets the required specifications or Pharmacopeia
      • Number of containers required w.r.t. qty needs to be transferred in another code shall be included during sample qty transfer in SAP by stores to generate the numbers of labels to be affixed on containers after stock transfer by QA.
      • QC shall collect the samples as per compliance of the respective SOP along with a copy of ‘Code Transfer of Materials Request/ Additional Test Request’ (Annexure-1) and shall arrange for analysis as per the proposed spec/STP.
      • Those parameters which are different from already approved materials and/ or testing method is different, shall be tested during code transfer.
      • After the completion of testing Head-QC, his / her designee shall submit the results to QA department for review and Head –QA, his / her designee shall finally approve the ‘Code Transfer of Materials Request/ Additional Test Request’ (Annexure-1) and send back to QC.
      • QC shall maintain the copy of approved ‘Code Transfer of Materials Request/ Additional Test Request’ (Annexure-1) along with complete report, deduct the sample qty. used in testing in the SAP and COA shall be sent to store along with the ‘Code Transfer of Materials Request/ Additional Test Request’ (Annexure-1).
      • If the material passes as per COA received from QC, officer stores shall fill the qty required as per plan in the respective column of approved ‘Code Transfer of Materials Request/ Additional Test Request’ (Annexure-1) and send to QA for transferring the qty. in SAP.
      • QA shall do the transaction for the qty in SAP, sign the ‘Code Transfer of Materials Request/ Additional Test Request’ (Annexure-1), and send back to Store for their records.
      • Store shall update their stock ledger after verification in the SAP and inform to QC for labeling on containers.
      • Approved label which were already generated after QA approval, shall be affixed on each container by QC Personnel. Thus all containers in a consignment of the approved material shall display approved stickers separately of the two codes until qty remain in existence of the batch.
    •    Procedure for Additional Testing
      • Additional testing of an API/Excipients/Drug Product shall be carried out in case of  requirement for compliance to other specifications/Pharmacopeia/Markets.
      • Based on the requirement, PDL/R&D/Production/QA/Stores shall raise an  ‘Additional Test Request’ (Annexure-1).
      • All fields of Annexure-1 which are not applicable shall be marked as ‘NA’.
      • In case of Finished Goods, QA shall raise Additional Test Request and the same shall provide to QC along with samples.
      • On receipt of the request, QC shall arrange for the additional testing. If the material
      • is already analyzed and approved under Item code ‘A’, re-sampling shall be done as per respective SOP for additional testing.
      • Sampling details and analytical results shall be recorded in ‘Additional Test
      • Request’ format and relevant COAs shall be appended.
      • After the completion of testing Head-QC shall submit the results in QA department
      • for review and Head QA shall finally approve the Additional Test Request.
      • After the QA approval, QC shall generate the COA as per testing performed and submit to relevant department.
  • Forms and Records

Transfer code of Materials / Additional Test Request –   Annexure -1

Code Transfer of Material Log –   Annexure -2

  •   Distribution

Master Copy                   –          Documentation Cell (QA)

Controlled Copies              –           Quality Control, Quality Assurance, Stores, R&D, Production and PDL.

  • History 
Date Revision Number Reason for Revision
New SOP

Annexure -1

Code to Code transfer of Material Request/Additional Test Request

Requisition No           :

Date                            :

Particulars Existing Transfer Details
Name of Material
Grade ( Pharmacopeia)
Material Code No.
Specification No.
PBL Batch No.*
Attached CoA

* COA needs to be attached along with request.

Initiated By:                                                   Reviewed By:                                                      Approved By:

 

(Name/Dept./Date)                                       (Name/Dept./Date)                                                    (Head- QA)

Remarks (if any):                                                                                                                                   __________ 

TO BE FILLED BY QC

                                   Please perform the additional tests as per the proposed specification 

Sample Quantity: _________________                                                Sampled by (Sign/ Date): _________________        

COA Enclosed / Not Enclosed                                                            A.R No. of the COA      : _________________ 

Material Approved/ Rejected:

Analyst (Sign/ date): _________________                                         Head QC (Sign/date):   _________________ 

Enclosed: two copies of COAs

Based on the results of analysis, Code Transfer of Material request/Additional test request is approved.

 

Approved By: ______________

Head QA (sign/date)

 

To be filled by Store                                                                                                            To be filled by QA

Qty required for transfer to another code as per calculation                                  Transaction done date and

Item Code:                                                                                                             Signature of QA officer

Qty:

Annexure – II

Log for Code to Code Transfer of Material

Sl. No. Date Particulars Requisition No. Requisition No. given by Remarks
1.

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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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