Standard Operating Procedure for Batch Reconciliation in Aerosol Production
1) Purpose
The purpose of this SOP is to outline the procedures for batch reconciliation in aerosol production. Batch reconciliation ensures that all raw materials, intermediates, and finished products are accurately accounted for, thereby ensuring product quality and regulatory compliance.
2) Scope
This SOP applies to all batch reconciliation activities in the aerosol production process at [Company Name]. It covers the reconciliation of raw materials, intermediates, and finished products from the start of production to the final release of the batch.
3) Responsibilities
Production Technicians: Record usage of raw materials and intermediates during production.
Quality Control (QC) Analysts: Verify the quantities of raw materials and finished products.
Quality Assurance (QA) Personnel: Review and approve batch reconciliation records.
Inventory Control Personnel: Monitor and document inventory levels and discrepancies.
4) Procedure
4.1 Pre-Production Checks:
4.1.1 Verify the availability and quantity of raw materials against the Bill of Materials (BOM).
4.1.2 Record initial inventory levels of raw materials in the batch record.
4.2 During Production:
4.2.1 Record the exact quantities of raw materials used at each production stage.
4.2.2 Document any deviations or adjustments made during production and report to the QA.
4.3 Post-Production Reconciliation:
4.3.1 Calculate the total quantity of raw materials used and compare it with the initial inventory levels.
4.3.2 Record the quantity of intermediates and finished products produced.
4.3.3 Document any discrepancies between the theoretical and actual yields.
4.4 Review and Verification:
4.4.1 QA personnel review the batch reconciliation records for accuracy and completeness.
4.4.2 Verify that all discrepancies have been investigated and resolved.
4.5 Final Approval:
4.5.1 Obtain final approval of the batch reconciliation from the QA manager.
4.5.2 Document the approval in the batch record.
4.6 Recordkeeping:
4.6.1 Archive batch reconciliation records according to the document retention policy.
4.6.2 Ensure that records are easily accessible for audits and inspections.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance
BOM: Bill of Materials
6) Documents, if any
Batch Records
Bill of Materials (BOM)
Inventory Logs
7) Reference, if any
GMP Guidelines
Pharmacopeial standards (e.g., USP, EP)
Regulatory Requirements (e.g., FDA, EMA)
8) SOP Version
Version 1.0
