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 SOP is applicable for code transfer of same material from one code to another and to carry out additional testing of APIs, Excipients and Drug Products.
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.
Accountability
- Department Head & QA Head shall be accountable for implementation of this SOP.
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
- Procedure for code transfer
‘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.
5.2.8 After the QA approval, QC shall generate the COA as per testing performed and submit to relevant department.
Forms and Records (Annexures)
Transfer code of Materials / Additional Test Request – Annexure -I
Code Transfer of Material Log – Annexure -II
Flow chart of Transfer code of materials/ Additional Test Request – Annexure -III
Distribution
Master Copy – Documentation Cell (QA)
Controlled Copies – Quality Control, Quality Assurance, Stores, R&D,
Production and PDL.
Reference:
If any
History
| Date | Revision Number |
Reason for Revision |
