Code to Code Transfer of Materials and Additional Testing of Materials / Products in Pharma Industry
- Objective
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 in Pharma Industry.
- Responsibility
- Officer or above – Stores shall be responsible for raising the Code to Code Transfer of Material Request/ Additional Test Request.
- Officer or above – QC shall be responsible for conducting the testing as per request.
- Concerned department Head, Designee shall be responsible for reviewing the Code to Code Transfer of Material Request/ Additional Test Request.
- Head QA /Designee shall be responsible for approving ‘Code to Code Transfer of Materials Request/ Additional Test Request’ and transfer of quantity in ERP.
- Accountability
- QA Head shall be responsible for the implementation of the SOP.
- Abbreviations and Definitions
API : Active Pharmaceutical Ingredient
ERP : Enterprises Resource Planning (Integrated software)
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 in Pharma Industry.
Procedure in Pharma Industry
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 in Pharma Industry
- Based on the requirement Stores shall raise a ‘Code to Code Transfer of Materials Request/ Additional Test Request’ as per Annexure – I 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 QA and log shall be maintained for the same as per Annexure-2.
- Requisition number of Code transfer of material shall be of nine alpha-numeric characters.
- Numbering shall follow following format CT/XX/YYY, where CT stands for code transfer, XX denotes last two digits of calendar year and YYY denotes serial no. starting from 001, 002, and 003 and so on.
- After QA approval on code transfer for material, Store personnel shall send the request to QC for sampling and testing on ‘Code to Code Transfer of Materials Request/ Additional Test Request’ (Annexure-1) and subsequently required qty for sample shall be updated in the ERP 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 ERP 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 to 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 to Code Transfer of Materials Request/ Additional Test Request’ (Annexure-1) and send back to QC.
- QC shall maintain the copy of approved ‘Code to Code Transfer of Materials Request/ Additional Test Request’ (Annexure-1) along with complete report, deduct the sample qty. used in testing in the ERP and COA shall be sent to store along with the ‘Code to 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 to Code Transfer of Materials Request/ Additional Test Request’ (Annexure-1) and send to QA for transferring the qty. in ERP.
- QA shall do the transaction for the qty in ERP, sign the ‘Code to 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 ERP 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 in Pharma Industry
- 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, Production/QA/Stores shall raise an ‘Code to Code Transfer of Materials Request/ 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 Code to Code Transfer of Materials Request/ 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
Code to Code Transfer of Materials / Additional Test Request – Annexure -I
Log for Code to Code Transfer of Material – Annexure -II
Flow chart of Transfer code of materials/ Additional Test Request – Annexure -III
Distribution
Master Copy – Quality Assurance
Controlled Copies – Quality Control, Quality Assurance, Stores, Production .
History
| Date | Revision Number | Reason for Revision |
| – | – | New SOP |
Annexure-I
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. | ||
| 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: 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
| Sr. No. | Date | Particulars | Requisition No. | Requisition No. given by | Remarks |
| 1. |
AMOXICIILIN AND POTASSIUM CLAVULANATE TABLETS BP
20
20
20