Qualification Services
Process Equipment Qualification & Analytical Instrument Qualification
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 analytical instruments and the 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.
Your Benefits:
- Contributing to qualified instruments and process equipment
- Contributing to manufacturing license and manufacturing authorization
Our Expertise
- Sound and proven knowledge of analytical instrument qualification and process equipment qualification
- Sound and proven knowledge of GMP regulations and requirements (FDA, EMA)
- Annex 11
- Annex 15
- EU GMP Guide
- Eudralex Vol. 4
- FDA CFR 21 Parts 210 and 211
Our GMP Qualification Services
- Analytical Instrument Qualification
- Process Equipment Qualification
- Designing Risk Analysis and Test Protocols
- Generating User Requirement Specifications (URS, DQ)
- Supporting testing activities: FAT, SAT, IQ, OQ, PQ
- Commissioning of process plant and line facilities
- Facilitating and maintenance of qualification activities of premises, utilities and production equipment
- Supporting cleanroom validation (Annex 1)
- Preparing GMP-related documentation
- Concept planning of process plant and line facilities