Standard operating procedure of Disposal of Rejected Material in Pharmaceuticals Industry SOP SOP is desbribe in this post.
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1. Purpose:
1.1. To ensure proper disposal of “Rejected” Material
2. Scope:
2.1. This procedure applies to the disposal of incoming raw material and packaging materials for production, which is not conforming to standards..
3. Responsibilities:
3.1. Quality Assurance Manager
3.2. Quality Control Manager
3.3. QA Officer
3.4. Admin Manager
3.5. Inventory Control Manager.
4. Procedure:
4.1. The non-conforming material which cannot be re-worked is then labeled “Rejected” and material is segregated to “Quarantine Area for the Rejected Materials” in clearly designated enclosure.
4.2. Quality Control Manager informs Inventory Control Manager of this decision. Inventory Control Manager informs Purchasing and Accounts Departments.
4.3. Inventory Control Manager adjust material inventory by reverse entry in store ledger and in computerized record.
4.4. Locally purchased material is returned to the supplier.
4.5. When the material is “Rejected” due to
i) Adverse Storage conditions.
ii) Production Processing
iii) Non-conforming Imported Material.
Q.A. Incharge fills out Non conformity Report F-07-009 and both QA Incharge & QC Managers jointly decide to scrap the material. After approval of scrapping by Plant Manager, material is destroyed in presence of QA Officer & member of Inventory Control Department. Disposal is recorded on form F-7-008and forwarded to Manager Finance
4.6. When material is non-conforming due to.
i) Life Expiry (with no possible extension of date)
ii) Discontinuation of the Product or
iii) Change of text in packaging material (for packaging material only)
4.7. Inventory Control Manager after notification from QC Manager and approval from Plant Manager initiates a Write Off of the rejected material with Accounts Department.