Standard Operating Procedure for Batch Reconciliation in Creams Production

1) Purpose

The purpose of this SOP is to outline the procedures for reconciling materials used during the production of creams to ensure accuracy and traceability of raw materials, intermediates, and finished products.

2) Scope

This SOP applies to all personnel involved in the manufacturing, quality assurance, and quality control of creams, including production operators, QA personnel, and supervisors. It covers the procedures for batch reconciliation from raw material dispensing to finished product packaging.

3) Responsibilities

It is the responsibility of production operators to accurately record all material dispensing, usage, and waste during the production process. QA personnel are responsible for verifying and approving batch reconciliation records to ensure compliance with approved procedures and specifications.

4) Procedure

4.1 Raw Material Dispensing

4.1.1 Retrieve raw materials from approved storage areas according to the batch record instructions.

4.1.2 Weigh and document the quantities of raw materials dispensed, ensuring accuracy and adherence to the approved formulation.

4.1.3 Label containers with appropriate identification and batch numbers before transferring to the production area.

4.2 Manufacturing Process

4.2.1 Record all materials used during the manufacturing process, including active ingredients, excipients, and processing aids.

4.2.2 Document any deviations or adjustments made to the batch formulation during