Commisioning, Qualification
& Validation Services
Our Work
Professional that provide pharma solutions
The agenda is set by the requirements of the client. Together, we establish the task's framework. The GMP consultants give experts the skills necessary to come up with the optimal solution
Core Services
The certification and validation phase is where we can step in and assist the user organization whole or in part.
Validation
We provide skills in the preparation of all validation documents, including those for
• Process validation
• Classed facilities and supply systems
• Testing and validation of pharmaceutical and biotechnological production equipment
• Completion of the project. PQ | PPQ | EMP| QDQ | IQ | OQ |
• Process validation
• Classed facilities and supply systems
• Testing and validation of pharmaceutical and biotechnological production equipment
• Completion of the project. PQ | PPQ | EMP| QDQ | IQ | OQ |
Qualification
The creation of all types of GMP
• Documentation
• Comprising deviations
• Vulnerability assessments
• Validation plans
• Qualification
• Validation
• Maintaining of the validated condition
• Supports for FDA and EMEA checks including URS - VPL - VMP - FMECA - SOP and NC
• Documentation
• Comprising deviations
• Vulnerability assessments
• Validation plans
• Qualification
• Validation
• Maintaining of the validated condition
• Supports for FDA and EMEA checks including URS - VPL - VMP - FMECA - SOP and NC
Documentation
• Specifiactions and procedures for all materials and methods of manufactures and control
• All personel know what to do and when to do it
• Authorized persons have all information necessary for realease of product
• Documented evidence, traceability, records and audit trail for investigation
• Availibity of data for validation, review and statistical analysis
• All personel know what to do and when to do it
• Authorized persons have all information necessary for realease of product
• Documented evidence, traceability, records and audit trail for investigation
• Availibity of data for validation, review and statistical analysis
Documentation
The creation of all types of GMP documentation, comprising deviations, vulnerability assessments, validation plans, qualification, validation, and maintaining of the validated condition, as well as supports for FDA and EMEA checks, including URS - VPL - VMP - FMECA - SOP and NC
Project Management
We have extensive expertise in managing projects in the pharmaceutical and biotechnology industries. We frequently complete projects on schedule, within budget, and to the appropriate quality standard. We frequently provide assistance with the creation of investment applications and are trained in and experienced with the stage-gate concept.
GMP Consultants
With us GMP validation experts include highly qualified engineers with in-depth understanding of pharmaceutical and biotech manufacturing, involving tools, materials, automation, settings, and procedures, and also the necessary GMP paperwork.
Comisioning, Qualification
& Validatioon Model (CQVM)
Our Team
Would you like to get in touch with one of our sales representatives, an expert, or our marketing department?
We are always ready to answer your questions.
CPH Pharma consists of extremely skilled and diverse engineers and experts of all ages specializing in the pharmaceutical and Life Science industries.
- Address: Kirke Værløsevej 34, 3500 Værløse
- Hours: Mon-Fri 9:00AM - 5:00PM
- Phone: 71 61 92 34
- Email: info@cphpharma.dk