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 test runs to validate equipment setup and functionality.
4.5 Documentation
4.5.1 Document all changeover activities, including cleaning records, inspection results, and setup parameters.
4.5.2 Update batch records and equipment logbooks with changeover details.
5) Abbreviations, if any
SOP – Standard Operating Procedure
QA – Quality Assurance
6) Documents, if any
Changeover Checklist
Cleaning Validation Reports
Batch Records
7) Reference, if any
Current Good Manufacturing Practices (cGMP) guidelines
Internal Standard Operating Procedures (SOPs)
8) SOP Version
Version 1.0
