It is now widely appreciated that pharmaceutical users of labelling machines are required to validate machines and their various component systems to show full specification compliance.
The validation process is technically complex, time-consuming and costly. It may even prove impossible with certain equipment designs.
The Newman Validation Package provides a fast, cost-effective and reliable solution to the need for FDA and EMEA regulatory compliance.
The Newman Solution
The Newman Validation Package provides a fast, cost-effective and reliable solution to the need for regulatory compliance and enables pre-production validation to be completed by experienced Newman engineers during pre-delivery trials and on-site commissioning.
Machine-specific documentation accompanies each model from the Newman ‘Validation Friendly’ range of labelling machines. They have been specifically designed from first principles to GMP standards, with FDA and EMEA compliance as a major attribute. The mechanical, electrical and software constituents of each labelling system and all relevant sub-systems are thoroughly tested and documented to provide the information that is essential for successful validation.
- Machine Validation Masterplan
- Software Quality Statement
- Design Qualification Statement
- Microprocessor Control System Validation
- Pre-delivery Machine Test Protocol
- Product Test Results
- Installation Qualification Protocol
- Operational Qualification Protocol
- Satisfies essential regulatory compliance
- Reliable production start date
- Reduced project costs
- Greater operator awareness
- Speedy, systematic fault-finding
- Confidence in machine performance
- Ease of revalidation
- Single information source
This carries the overall objective of ensuring that the machine, as supplied and installed:
- Meets customer expectations;
- Performs according to Newman design intentions;
- Complies with GMP standards;
- Is provided with a record of key features and components as initially installed;
- Is provided with information to enable safe, effective and consistent operation and maintenance;
- Has had its systems tested and verified as being in correct working order, to enable full process Newman policy is one of continual validation to be performed.
Software Quality Statement
This provides details of how Newman is compiled and tested; and how the necessary change control procedures are implemented.
Installation Qualification will be completed during the commissioning of Newman equipment. It will ensure compliance with the customer specification, pre-delivery test data and required utility connections.
The Operational Qualification ensures that during commissioning the Newman equipment performs to customer requirements and undergoes a full system check, in order for full process validation to be performed safely with repeatable results.
Newman personnel are available to provide further guidance and assistance with the validation of Newman equipment.
The Newman Quality Assurance System is approved to ISO9001:2000 standards.
Newman policy is one of continual improvement. Illustrations and specifications cannot be held binding in detail.