Standard Operating Procedure for Analysis and Release of Stock Transfer Material from one code to another.
To lay down a procedure for Analysis and Release of Stock transfer material from one code to another.
The scope of this SOP is applicable for Analysis and Release of Stock transfer material from one code to another at [company name].
QC Personnel: To check the Specification for code transfer material.
Head QC/ Designee: To approve the code for transfer material.
- Only “Approved Material” should be transferred from one code to another.
- This is applicable for material transfers from one plant to another and from one Pharmacopoeia to another.
- This is applicable for situations involving a shortage of material, specific grade requirements during transfers to internal locations, and intra-location transfers.
- The Manufacturer’s Certificate of Analysis (CoA) should be checked.
- Transferred material should be treated as new material.
- The QA department should be informed through a notification report confirming the Original and New code numbers, Control Number, and Quantity. The transfer process should only be completed after QA authorization.
- QC Personnel should check the availability of the manufacturer’s COA for the required material.
- They should verify the specification against the transferred code specification and plan for the required test to be performed.
- If the tests are exactly the same for both codes, the test result of the previous code should be used.
- If the tests are found to be different from those of the previous code, the tests should be performed as per the “SOP for Analysis and Release of Raw Material”.
- The Sample in Charge or Section Head/Designee should allocate the respective test to the analyst.
- The analyst should perform the analysis as per the specification.
- The reviewer should review the data and approve the material as per the “SOP for Review of Analytical Reports”.
- After reviewing the data, Raw Material should be released as per the “SOP for Analysis and Release of Raw Material”.
6.0 Acceptance Criteria:
As and when required.
8.0 Format for recording: