Procedure for Managing Discrepancies in Batch Yield

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish a systematic process for identifying, analyzing, and resolving batch yield discrepancies in aerosol manufacturing. This ensures batch consistency, prevents material losses, and maintains compliance with GMP standards.

2. Scope

This SOP applies to all batch production processes, including raw material input, formulation, filling, and packaging of aerosol products.

3. Responsibilities

• Production Team: Responsible for monitoring yield during batch processing.
• Quality Assurance (QA) Team: Responsible for investigating and approving corrective actions.
• Quality Control (QC) Team: Responsible for verifying material usage accuracy.
• Warehouse Team: Responsible for reconciling raw material issuance with batch records.

4. Accountability

The Production Manager is accountable for ensuring batch yield discrepancies are documented, investigated, and corrected.

5. Procedure

5.1. Monitoring Batch Yield

1. Track batch yield at each stage of production.
2. Compare actual yield with expected yield as per the Batch Manufacturing Record (BMR).
3. Record yield data in the Batch Yield Monitoring Log (Annexure-1).

5.2. Identifying Batch Yield Discrepancies

1. Identify deviations if the actual yield is outside the allowable range.
2. Cross-check raw material consumption and losses.
3. Document discrepancies in the Batch Yield Discrepancy Report (Annexure-2).

5.3. Investigating Discrepancies

1. Conduct root cause analysis to determine