Retesting of Raw Materials Through SAP System : Pharmaceutical Guidelines

Editable Pharmaceutical Documents in MS-Word Format

View

8

Retesting of Raw Materials Through SAP System

Learn how to retest the Raw Material using the SAP system.
1. Raw material stores shall take out the list of the raw materials due for retesting and transfer the materials to the quarantine area.
2. ‘’QUARANTINE” labels shall be affixed to the container due for retesting.
3. The lot due for retesting is viewed in SAP system through the QA32 transaction. The movement type is 09 by which retesting lot (recurring inspection) is generated in the SAP system.
4. Quality control will carry out sampling as per following procedure.
5. Sampling procedure for retesting materials: Follow all the general guidelines under SOP.

6. The sample shall be taken from the underuse or previously opened container from each control number.
7. Since the basic purpose of retesting is to evaluate the suitability of material after storage it will be ensured that the material will undergo retesting after a specified period.
8. The analysis shall be carried out of such material, during the period of -15 days and +30 days of the due date of retest.
9. Under no circumstances, such material under retest should be issued to production.
10. After analysis, the new retest date must be recorded on the COA.
11. Approved labels shall be affixed on all the containers, in case the material is found suitable and the same shall bear new date of approval.





Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
.moc.enilediugamrahp@ofni :liamENeed Help: Ask Question


Click Here

1 comment: Post Yours! Read Comment Policy ▼


Popular Categories

QA SOPs QC SOPs Micro SOPs HVAC Production SOPs Stores SOPs Checklists Maintenance SOPs HPLC Sterile GLP Validation Protocols Water System GDP Regulatory Maintenance Calibration Warning Letters

Follow Pharmaguideline


Discussion - Latest Topics

Show All ❭❭Pharmaguideline Forum

DOCUMENTS

PHARMACEUTICAL DOCUMENTS




Editable Pharmaceutical Documents in MS-Word Format. Ready to use SOPs, Protocols, Master Plans, Manuals and more...

View


adsbypg



GET APP FOR NEWS UPDATES

Scan to Download

Android App
Android App

Recent Posts