Services
Services
Cleaning Validation
A robust manufacturing process goes hand in hand with a robust cleaning process. Our team of SMEs has the technical experience and regulatory knowledge to help you build, strengthen and maintain a compliant and effective Cleaning Validation program to support your production needs.
We can help you with:
- Drafting policy documents, SOPs, VMPs
- Cleaning Performance Qualification following a 3-stage lifecycle approach: Development, Validation, Monitoring
- Designing protocols, executing studies, drafting reports
- Performing risk assessments
- Calculating acceptance criteria/limits for testing
- Investigating and resolving deviations
- Implementing CAPAs
- Conducting recovery studies
Project Management
Our cross-functional expertise allows us to speak the same language to ensure smooth project delivery. We understand the interconnectivity of the various elements of a project, as well as the constraints and requirements of each participating function. This allows us to equally provide value on a granular as well as holistic scale throughout all phases of your project.
Cleaning Validation intersects with:
- Engineering
- Equipment IOQ
- Process Performance Qualification
- Quality Assurance
- Quality Control
- Environmental Monitoring
- Regulatory Affairs
- Change Control
- Data Science
- Metrology
Quality Engineering
“Right the First Time” is one of the core principles of our methodology at SPMC. We combine technical knowledge and a quality mindset to ensure proper solution implementation and a framework for future process improvement – what we like to call “Quality Engineering”.
Our methodology consists of:
- Thorough, all-encompassing initial risk assessments
- Small-scale pilot studies
- Influence on equipment and process design
- Comprehensive development of cleaning procedures with optimized CPPs and CQAs
- “Worst-Case” approach in design and execution phases
- Data analysis for continuous process monitoring and improvement
Auditing & Gap Assessment
Do you need a second pair of eyes to look over your established Cleaning Validation program? Are you preparing for an upcoming inspection and are looking to cover all your bases?
Our team of SMEs will gladly help in reviewing your systems, policies, procedures, protocols and reports, to identify potential opportunities for improvement.
We do not limit our auditing efforts to Cleaning Validation itself, but strive to cover other ancillary functions as well, as they relate to Cleaning Validation. This includes, but is not limited to:
- Test Method Validation
- Quality Management System
- Equipment IOQ and maintenance
- Process Performance Qualification
- Environmental Monitoring
Training, Learning & Development
Are you interested in learning more about Cleaning Validation? Are you looking to develop basic competencies, or receive specialized training in particular areas of Cleaning Validation?
SPMC is committed to providing high-quality training sessions focused on Cleaning Validation concepts, principles, guidelines and best practices – all tailored to your specific needs.
Cleaning Validation
A robust manufacturing process goes hand in hand with a robust cleaning process. Our team of SMEs has the technical experience and regulatory knowledge to help you build, strengthen and maintain a compliant and effective Cleaning Validation program to support your production needs.
We can help you with:
- Drafting policy documents, SOPs, VMPs
- Cleaning Performance Qualification following a 3-stage lifecycle approach: Development, Validation, Monitoring
- Designing protocols, executing studies, drafting reports
- Performing risk assessments
- Calculating acceptance criteria/limits for testing
- Investigating and resolving deviations
- Implementing CAPAs
- Conducting recovery studies
Project Management
Our cross-functional expertise allows us to speak the same language to ensure smooth project delivery. We understand the interconnectivity of the various elements of a project, as well as the constraints and requirements of each participating function. This allows us to equally provide value on a granular as well as holistic scale throughout all phases of your project.
Cleaning Validation intersects with:
- Engineering
- Equipment IOQ
- Process Performance Qualification
- Quality Assurance
- Quality Control
- Environmental Monitoring
- Regulatory Affairs
- Change Control
- Data Science
- Metrology
Quality Engineering
“Right the First Time” is one of the core principles of our methodology at SPMC. We combine technical knowledge and a quality mindset to ensure proper solution implementation and a framework for future process improvement – what we like to call “Quality Engineering”.
Our methodology consists of:
- Thorough, all-encompassing initial risk assessments
- Small-scale pilot studies
- Influence on equipment and process design
- Comprehensive development of cleaning procedures with optimized CPPs and CQAs
- “Worst-Case” approach in design and execution phases
- Data analysis for continuous process monitoring and improvement
Auditing & Gap Assessment
Do you need a second pair of eyes to look over your established Cleaning Validation program? Are you preparing for an upcoming inspection and are looking to cover all your bases?
Our team of SMEs will gladly help in reviewing your systems, policies, procedures, protocols and reports, to identify potential opportunities for improvement.
We do not limit our auditing efforts to Cleaning Validation itself, but strive to cover other ancillary functions as well, as they relate to Cleaning Validation. This includes, but is not limited to:
- Test Method Validation
- Quality Management System
- Equipment IOQ and maintenance
- Process Performance Qualification
- Environmental Monitoring
Training, Learning & Development
Are you interested in learning more about Cleaning Validation? Are you looking to develop basic competencies, or receive specialized training in particular areas of Cleaning Validation?
SPMC is committed to providing high-quality training sessions focused on Cleaning Validation concepts, principles, guidelines and best practices – all tailored to your specific needs.