SOP for Code to Code Transfer

This Document describes (Standard Operating procedure) SOP for Code to Code Transfer.

 SOP for Code to Code Transfer.

I. Purpose & Scope:

• The purpose of this Sop for Code to Code Transfer.
• This Standard operating procedure shall be applicable for Code to Code Transfer.

II. Responsibilities:

• All warehouse personnel shall be responsible to follow and implement this SOP.

III: Introduction and Procedural Part:

Prerequisites:

• Item codes which are vendor (Manufacturer) specific shall not be subjected for code to code transfer from any other codes material i.e. other manufacturer for BOM listed vendor
• Item codes under re-testing shall not be referred for transfer in other codes.
• Item code of non DMF grade shall not subjected for code to code transfer from non DMF to DMF/CEP grade.
• Code to Code transfer only applicable for transfer of USP/BP grade to IP, not for IP to BP/USP. Grade to grade transfer can be deemed acceptable for USP to BP and Vice a versa if complies pharmacopeia monograph.
• This procedure is applicable for only already QC tested and Approved APIs and Excipient which are lying in the Akriti Pharma warehouse.

Procedure for code to code Transfer:

• Based on the requirement, Stores executive/officer shall raise a ‘Code Transfer of Materials Request’ as per Annexure -I.
• Store officer shall segregated the required quantity of the materials as per Code Transfer request (Annexure-I).
• Assigning of Requisition number of code transfer of material.
• Number shall be assigned by Stores in seven alpha-numeric characters.
• Numbering shall follow following format CTXXYYY,
• where CT stands for Code Transfer, XX denotes last two digits of calendar year and YYY denotes serial no. starting from 001, 002, 003 and so on.
• Store officer shall forward request to warehouse In-charge for review , approval by QA and authorization by operation head.
• After operation head authorization, Stores shall send the request to QC for allocation of new AR. No.
• QC generates the AR. No. in sequential manner by suffixing “C” to existing AR. No. and send request to QA for sampling.
• After receipt of code to code Transfer request as per Annexure-I, QA officer carry the things as per the SOP, and send the sample to QC for analysis.
• QC shall carry out analysis as per respective Specification and Standard Test Procedure (STP). Those parameters which are different from already approved materials and/ or testing method is different, shall be tested during code transfer
• If the material comply in proposed grade, QC officer affix the approved label on container as per SOP.If material does not comply in proposed grade, transfer of grade to grade transfer shall be considered as rejected i.e. material shall not be used in proposed grade. OOS procedure shall not be applicable for the same.
• Certificate of Analysis (COA) of tested materials shall be prepared as per SOP
• After affixing of Approved Label by QC officer, Store officer shall transfer the approved stock quantity of materials to proposed code.
• Transfer of the material between the different codes of the same material having different brand or Compendia status shall be done only if it meets the required specifications or Pharmacopeia.

IV: Annexure:

ANNEXURE-I

MATERIAL GRADE-TO-GRADE TRANSFER REQUEST    

ANNEXURE-II

MATERIALS CODE TO CODE TRANSFER REGISTER       

Reviewed by:

(Warehouse Sign/Date)