GMP Qualification Services
„Vital GMP Engineering“
“We use mind and reason to implement your qualification strategies.”
A large variety of analytical instruments, equipment and devices are essential for manufacturing and quality control of biopharmaceuticals. Most of these instruments link metrological and software-controlled functions. PQS and QM are responsible for assuring that their instruments are suitably qualified.
A risk-based approach is recommended to identify detailed instrument operating parameters to be qualified. This approach also defines the instrument classification to determine the extent of qualification activities. Use of qualified instruments is mandatory, as it is required by regulatory authorities and contributes to client’s confidence that the instruments perform suitably according to their intended purpose.
What are the necessities of instrument and equipment qualification?
Demonstrating that the equipment is suitable for its intended use is elaborate and labor-intensive. It depends upon experience and expertise, as there are predetermined specifications and GMP regulations to meet. It is, therefore, beneficial to know and have worked with the analytical instruments and process equipment.
Hands-on and long-term experience with instrument and equipment qualification will be applied to your qualification activities by our dedicated and well-versed validation engineers.
Our GMP Qualification Services
- Performing testing activities: FAT/SAT, IQ, OQ, PQ
- Devise of User Requirement Specifications (URS) and DQ
- Devise of Risk Analysis
- Devise of Test Protocols
- Preparing GMP Documentation: Qualification Master Plan, SOPs and Master SOP, Reports and Final Reports
Our GMP Qualification Expertise
- Hands-on experience with analytical instruments and process equipment
- European Commission’s Guide to GMP (EudraLex Vol. 4)
- ICH Quality Guidelines (Annex 15)
- ICH Quality Guidelines (Annex 11)
- ISPE
- Quality Risk Management
- Data Integrity and computerized Systems (CS)
Your GMP Qualification Benefits
- Contributing to qualified instruments and process equipment
- Contributing to manufacturing authorization
- Contributing to clinical trial and marketing authorization