Quality Standards
Successful integration of Global Quality Standards at each phase of product development life cycle is a pre-requisite at Fentech and a constant priority. Meticulous assessment of applicable requirements combined with a proactive approach to implementing quality and regulatory standards are proven aspects for a successful project at Fentech. Global regulatory and quality standards have been used while designing the quality systems and compliance standards at Fentech. The quality standards are harmonized across all Fentech’s departments and governed by Corporate QA policies. The quality systems are continuously monitored and reviewed, with the involvement of Senior Management, to identify areas for improvement.
GMP
This manufacturing facility was audited in the month of Jun 2020 for good manufacturing practices of API and Received Indian GMP complies
GLP
We have extensive experience in process development, analytical method validation and process validation under Good laboratory practice GLP regulations.
ISO
Upgrade facility as per ISO certified. Health, Safety (ISO-18001-2007),Environment System( ISO-14001-2015),Quality System Management (ISO 9001- 2015).
Quality Control
Quality Control establishes procedures for quality control of incoming materials, in the process, intermediates, API and Drug Products. The state of the art quality control laboratories follow all the current guidelines for monitoring the strict quality of our products / analytical services.
Quality Assurance
Quality Assurance is responsible for implementing and monitoring of Quality Systems throughout the company. Quality Assurance ensures the continued compliance with GMP and regulatory requirements. Quality Assurance controls all the operations starting from raw materials to shipping of products.
Regulatory Affairs
National and International Regulatory Affairs is responsible for filing all regulatory documents to various regulatory authorities as per the requirement of the clients and addressing all regulatory queries from clients & authorities.
Global Harmonization System
Compliance with applicable global standards is a core element of Fentech world-class quality systems. All of our product labels and Safety Data Sheets are compliant with the Global Harmonization System (GHS) of Classification and Labeling of Chemicals.
Labeling & MSDS
GHS creates common classification standards and communication protocols for chemical product labels and material Safety Data Sheets (SDS). It standardizes these important hazard communications so customers – regardless of their locations – can easily identify hazard information related to chemical products.
Packaging
All Packaging shares a common design approach: containers crafted to match specific use, cost and operational requirements. This includes fully integrated, state-of-the-art chemical delivery platforms such as our Aluminum Bottle, Glass Bottle, HDPE Carboy, HDPE Drum for our product delivery systems.
