1. Purpose
• SOP is established to provide a standard procedure for the step wise completion of a product batch record starting from the issuance of materials up to its final packaging.
• SOP provides the procedure for record of personnel performing different tasks of manufacturing at various stages.
• SOP also helps trace the checks & controls subjected to the manufacturing processes.
• SOP outlines the procedure for reconciliation & batch yield calculation.
2. Scope
• Procedure is applicable to all manufacturing & packaging sections of production including the processes of issuance, manufacturing & packaging.
3. Responsibilities
• GM Production
• QC Manager
• Production Manager
• QA Manager
• Production Pharmacist
4. Reference:
• SOP for the issuance of Material (GL/SOP/P/001)
• SOP for Line Clearance (GL/SOP/008)
• SOP for Packaging Operation (GL/SOP/P/008)
• SOP for Destruction of Material (GL/SOP/P/002)
• SOP for the return of material to warehouse (GL/SOP/P/003)
• SOPs for Machinery & Equipment (All relevant SOPs)
5. Procedure
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There are five distinct stages to Business Analysis & Modeling. The Integrated Modelling Method lists and explains each of them in detail. All of these stages should be followed, regardless of whether you are modelling an enterprise with 5 employees, 5,000 employees or 25,000 employees. SOP Preparation
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