Quality Management Systems Audits in Pharmceuticals
WITHIN THE PHARMACEUTICAL SUPPLY CHAIN THE REGULATORY OBLIGATIONS FACING ALL THOSE INVOLVED ARE INCREASING.
A trusted partner, who specializes in quality management systems audits and certifications, with a firm base in Good Manufacturing Practices (GMP), and who can handle the volume, complexity and breadth of today’s regulatory environment in a globally consistent manner, has never been needed more.
COMPLEX REGULATORY LANDSCAPE
As the pharmaceutical industry continues to grow and developed markets evolve, more and more manufacturing is relocating to emerging markets. Regulatory obligations and guidance on efficacy, quality and safety throughout the entire product life cycle will continue to increase as industry regulatory bodies require drug companies to control and ensure the quality of their entire supply chain. Considering the distributed nature of today’s pharmaceutical supply chain, ensuring quality throughout is an enormous task. Drug companies wishing to conduct GMP auditing of their extended supply chains using their own resources are faced with the sheer complexity and volume of the supplier audits that must be conducted. In addition, governments in emerging markets are tightening regulations for the pharmaceutical industry in their countries. This brings suppliers more in line with what is accepted as good manufacturing practice in Europe and North America and gives these suppliers a valuable head start against their competitors as they vie for business from drug companies.
A RELIABLE PARTNER
As a global leader in quality management systems audits and certifications, The Kent Group can help parties across the entire pharmaceutical supply chain manage and improve the quality of their products in a globally consistent, reliable and efficient manner through services and solutions tailored specifically for pharmaceutical quality assurance.
The Kent Group runs one of the world’s largest networks of independent auditors of Quality Management Systems that are focused on US Food and Drug Administration and European Commission regulations and directives on GMP and provides outsourced quality assurance and good manufacturing practice services to customers around the world.
Providing a single point of contact for customers, while at the same time understanding and appreciating the cultural and regulatory differences from country to country we accel at transferring our industry knowledge back to our customers.
The Kent Group provides a wide range of cGMP, Risk Based solutions for the entire pharmaceutical and bio-tech industries supply chain, including drug manufacturers, suppliers and regulators.
Locally Based with a global Reach
When a US based drug company needed to monitor the compliance of one of their active pharmaceutical ingredients (API) suppliers in Asia. The drug company turned to the Kent Group to verify the actual quality status of the API supplier, which The Kent Group performed during a two-day GMP audit of the supplier against the accepted and harmonized global standard for API manufacturers, ICH Q7A. The drug company was able to use the Kent Group audit report to their advantage during a standard regulatory agency inspection.
WHY The Kent Group?
For more than 10 years, The Kent Group has built its brand as an object, non-bias verification and validation Company.
The Kent Group provides a vast array of cGMP compliant analytical techniques for the quality control of pharmaceuticals, Distribution and packaging. The combination of strong technical expertise combined with more than 30 years of experience in GMP regulated contract services provides The Kent Group customers with a unique solution for their needs in pharmaceutical analysis.
COMPLIANCE MONITORING OF SUPPLIERS SUCH AS:
– MANUFACTURERS OF ACTIVE AND NON-ACTIVE INGREDIENTS
– CMOS AND PRODUCERS OF OTHER RAW MATERIALS AND SUPPLIES
– CONSULTANCY AND TRAINING SERVICES
– GLOBAL KEY ACCOUNT MANAGEMENT
– SUPPLIERS DRUG MANUFACTURERS
– CONSULTANCY AND GAP-AUDITING
– MANAGEMENT PERSONNEL
INITIAL SET UP AND MAINTENANCE OF QUALITY MANAGEMENT SYSTEMS COMPLIANCE MONITORING FOR SUPPLIERS TO ENSURE OPTIMAL QUALITY IS DELIVERED TO CLIENTS SUCH AS MULTINATIONALS, INCLUDING GENERIC PRODUCERS AND BIOTECH COMPANIES.
Call 973.402.5888 today! Contact us about KGA Pharmaceutical Quality Management Systems Audits and Certifications services.