Our validation documentation is designed to guarantee the successful operation of the equipment, as well as its full compliance with client specifications and below applicable regulations:

REGULATIONS AND GUIDELINES:
1）National Medical Products Administration (NMPA), China, Good Manufacturing Practice for Pharmaceuticals (revised in 2010 ), March 2011 .
2）U.S. Food and Drug Administration (FDA), Good Manufacturing Practice for Pharmaceuticals (2003) , December 2003 .
3）European Medicines Agency (EMA), Good Manufacturing Practice for Pharmaceuticals (2008).
4）Pharmaceutical GMP Guidelines, China, 2011.
5）Pharmacopoeia of the People's Republic of China 2020 edition.
6）Good automated manufacturing practice 5th edition.

We offer four levels of validation documentation packages, each tailored to the specific requirements of our clients, ensuring the equipment is designed, built, and operates to meet the agreed User Requirement Specifications (URS).

1. Design Qualification
- Design Qualification Documentation: Detailing the design requirements based on client specifications(URS).
- Design Review with Client: A thorough review of the design with the client to ensure all specifications are met.
- Cross-Reference List (URS – DS): A comprehensive list cross-referencing the URS with the design specification to ensure complete alignment.

2. Basic Documentation
- Quality Activity Plan: Outlines the quality activities during the validation process.
- Design Specification including Design Review: Finalized design documents with the client’s review and approval.
- URS – DS Cross-Reference List: Detailed mapping of customer’s URS to design specifications, ensuring compliance.
- Factory Acceptance Testing (FAT) Protocol & Report: A protocol for factory testing and a report validating that the machine meets specified performance criteria.
- Site Acceptance Testing (SAT) Protocol & Report: On-site validation that confirms proper installation and functioning in the operational environment.

3.Extended Documentation
- Quality Activity Plan: A detailed plan to ensure adherence to quality standards throughout the process.
- Design Specification including Design Review: Final design and review documentation.
- URS – DS Cross-Reference List: Ensuring all URS requirements are covered.
- FAT & SAT Test Protocol & Report: Comprehensive testing protocols for both factory and site acceptance.
- Installation Qualification (IQ) Protocol: Tailored to the client’s URS, ensuring the equipment is installed as intended and meets all technical and operational requirements.
- Operational Qualification (OQ) Protocol: A detailed testing protocol confirming that the equipment operates as required under specified conditions.

4. Full Validation Documentation
- Quality Activity Plan: A comprehensive plan to manage the entire validation lifecycle, ensuring quality throughout.
- Design Specification including Design Review: The final, validated design specification after client review.
- URS – DS Cross-Reference List: Final cross-referencing document showing all client and legislative requirements are met.
- FAT & SAT Test Protocol & Report: Protocols and reports for both factory and site acceptance testing.
- Validation Plan: A document outlining the overall strategy and approach for the validation process.
- Risk Management Plan: A plan detailing the risk mitigation strategies based on the design and customer specifications.
- FMEA Risk Analysis: A Failure Mode and Effects Analysis (FMEA) based on machine design specifications and the criticality of the product, as determined by the customer.
- IQ Protocol: Installation Qualification protocol developed in accordance with the FMEA analysis.
- OQ Protocol: Operational Qualification protocol based on the FMEA, ensuring the equipment operates as intended.
- Validation Summary Report: A comprehensive report summarizing the validation process and results, confirming the equipment meets all specifications and regulatory requirements.

By providing these documentation packages, we ensure that our pharmaceutical labeling machines meet the highest standards of design, performance, and regulatory compliance, ensuring peace of mind for our clients.