As a manufacturer of botanical and herbal extracts up to date with European and U.S. authorities latest requirements, we are committed to adopt state of the art technologies for the IDENTIFICATION, DEVELOPMENT and PRODUCTION of our raw materials and extracts
PtCell is committed to follow the “Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations” issued by FDA, and with ISO 9001 guidelines, with the intent to integrate QUALITY SYSTEM and RISK MANAGEMENT approaches into GMP with the aim of always encouraging the adoption of modern and innovative manufacturing technologies and integrated quality systems.
To adopt digital tools streamline operation, improve quality, and make it possible to produce our products more efficiently. A Quality Management System that is fully compliant and consistent with current Good Manufacturing Practice regulations.
The 7 key concepts of our Quality Management System:
Refers to the strength, purity, and other quality characteristics meant to ensure a product’s safety and effectiveness.
Designing and developing a product and associated manufacturing processes that will be used during product development to ensure that the product consistently attains a predefined quality.
This includes assessing the risks of quality issues, selecting and implementing risk management controls commensurate with the level of risk, and evaluating the results of the risk management efforts.
Focuses on investigating, understanding, and correcting discrepancies while preventing their recurrence.
Managing change to prevent unintended consequences.
A group within PtCell that promotes quality in general practice.
A model that can help us comply with CGMP regulations. The six systems referred to in this inspection model are: quality, production, facilities and equipment, laboratory controls, materials, and packaging and labeling.
This lead to the benchmark of our management philosophy. In every division of PtCell we follow the FDA overarching philosophy articulated in both the CGMP regulations and in robust modern quality systems: