Good Automated Manufacturing Practice (GMP) guidelines set by the International Society for Pharmaceutical Engineering (ISPE) cover all aspects of production from raw materials through to training and hygiene of staff. These guidelines provide a reliable model to ensure that pharmaceutical companies remain GMP compliant with Regulatory requirements while delivering the highest quality products to the end customer.
Zenith Technologies is your ideal partner in delivering projects which are compliant and to the highest standards of engineering excellence. We have a long experience and understanding of industry standards and guidelines. Our standard operating procedures and documentation are all designed in accordance with GAMP guidelines to better align with our customers quality requirements and Regulatory obligations.
The 5 Key Concepts of GAMP:
- Product and Process Understanding
- Lifecycle approach within a Quality Management System
- Scalable lifecycle activities
- Science based quality risk management
- Leveraging supplier involvement
|Project Life Cycle Management Solutions|
Full Proficiency Planning Model to ensuring project success.Read More...
Enterprise / System Integration
World leading Automation, Process Control and MES project implementation.Read More...
Commissioning and Qualification
Ensuring your system is fit for purpose and ready to go live.Read More...
Managing and optimising your investment for long term success.Read More...
ZT Learning your global Life Science Training PartnerRead More...