Standard Operating Procedure for Changeover Procedures Between Batches

1) Purpose

The purpose of this SOP is to establish procedures for the efficient and effective changeover of equipment between batches during the manufacturing of dental dosage forms to prevent cross-contamination and ensure product quality.

2) Scope

This SOP applies to all equipment and processes involved in the production of dental pastes, gels, and mouthwashes within the pharmaceutical industry.

3) Responsibilities

The Production Department is responsible for executing changeover procedures. The Quality Assurance (QA) Department is responsible for verifying compliance with this SOP.

4) Procedure

4.1 Preparation for Changeover

4.1.1 Schedule changeover activities based on production schedule and batch requirements.

4.1.2 Notify all relevant personnel about the upcoming changeover and assign responsibilities.

4.1.3 Gather necessary materials, tools, and cleaning agents required for changeover.

4.2 Cleaning and Sanitization

4.2.1 Clean equipment thoroughly using approved cleaning agents and procedures.

4.2.2 Disassemble equipment parts as per manufacturer’s instructions for cleaning and sanitization.

4.2.3 Perform swab sampling and visual inspection to verify cleanliness.

4.3 Inspection and Setup

4.3.1 Inspect equipment for any residue or foreign materials post-cleaning.

4.3.2 Set up equipment according to batch-specific requirements and standard operating procedures.

4.4 Product Changeover

4.4.1 Perform verification checks to ensure correct components, labels, and materials for the new batch.

4.4.2 Conduct trial runs or