Standard operating procedure for the purpose of reconciliation of raw & packaging materials in pharma.
1.0 Purpose
The purpose of this standard operating procedure is to develop a procedure for reconciliation of raw and packaging materials.
2.0 Scope
The current standard operating procedure is applicable for reconciliation of raw materials and packaging materials in store department.
3.0 Responsibility
3.1 Store supervisor & store officer are responsible for reconciliation of raw materials and packaging materials.
3.2 The Store HOD is responsible for ensuring the implementation of the current SOP.
3.3 Officer quality assurance monitors the compliance of this SOP.
4.0 Procedure
4.1 Store officer shall dispense released raw & packaging materials to the production department as per dispensing order.
4.2 Dispense the materials by following FIFO & consume the complete lot of a specific material.
4.3 The dispensed quantity of raw & packaging material is subtracted from received value in SAP/ERP/Manual system.
4.4 Store officer shall reconcile the raw and packaging material after consumption of a specific lot.
4.5 Store officer shall make a compression between initial released lot weight & actual consumed lot weight.
4.6 Calculate the difference in weight & percentage line loss for raw materials and packaging materials.
4.7 If the line loss after reconciliation is more than 0.5% (or as per in-house SOP) for active pharmaceutical ingredients, more than 1% for excipients & more than 2% for volatile solvent from released quantity an investigation shall be performed.
4.8 The line loss for packaging materials shall not be more than 1%.
4.9 If excessive line loss is observed during reconciliation for above-mentioned materials, the store officer shall intimate to the store head,QA & QC head.
5.0 Abbreviations
5.1 SOP: Standard Operating Procedure
5.2 QA: Quality Assurance
Also, Read