Quality and Supply Chain

QUALITY FOCUS & SUPPLY CHAIN TRANSPARENCY

At Bio-Clinton, quality is a key component of our brand promise and has been a main focus since the foundation of our company in 1967. We acknowledge the importance of high-quality standards for our clients and all of our products and services are developed to meet our customers’ expectations.

Bio-Clinton has expanded our global manufacturing footprint with each site holding the relevant quality standards for the market segment the products are manufactured for. Our Biopharma manufacturing facilities hold all the major certifications and applicable licenses from the main accreditation bodies and agencies:
  • ISO 9001:2015 certified*
  • GMP and GDP EXCiPACT certified for excipients
  • Health Canada Drug Establishment License for Active Pharmaceutical Ingredients manufacturing
  • FDA and Health Canada audited

Bio-Clinton legacy business of global sourcing and supply, prides itself on full transparency in the supply chain, full supporting documentation and strictly adheres to pharmaceutical supply chain best practices which are vital for compliance to GMP and GDP.

Quality Focus

 

At Bio-Clinton we are committed to providing services and products that meet both local and international quality and regulatory requirements. Our Quality Assurance and Quality Control teams are formed by highly skilled and qualified experts with many years of experience in the pharmaceutical industry. Their work ensures that our compliance with all pharmaceutical standards and requirements is constantly respected.

Our facilities are routinely audited by regulators, accreditation bodies and customers. Bio-Clinton demonstrates a strong commitment to being organized and compliant in accordance with regulatory requirements to sustainably meet the highest pharmaceutical and biopharmaceutical Quality standards. This is achieved through consistent implementation of our standard operating procedures and Quality Management System (QMS) which ensures strict compliance with Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP).

Quality Audit

Supply Chain Transparency

 

All our products have a supply chain statement available upon request, and customers are notified of significant changes through Bio-Clinton’s change control program. Our Quality Management System (QMS) outlines and ensures that our customers receive a product that continually meets the standards of quality, purity, safety and suitability for their manufacturing application.

Good Manufacturing Practice (GMP) processes and documentation control begin with incoming inspection, identity and in-house testing. These records become an integral part of the documentation chain of traceability that is maintained until the final product reaches the customer.

GMPs are at the core of our QMS, which also ensures that continuous improvement across our organization is maintained. This means that Bio Clinton will provide products meeting the most current standards required by the pharmaceutical and biopharmaceutical industries.

Supply Chain

OUR ACCREDITATIONS & OTHER INFORMATION

ISO Certification (9001:2015)


International Standards such as ISO are instrumental in facilitating international trade. ISO 9001:2015 Quality Management System (QMS) is an internationally recognized quality management standard implemented by over one million organizations in over 170 countries globally.

Bio-Clinton is currently ISO 9001:2015 certified. Implementing ISO Certification 9001:2015 has become an invaluable asset to Bio-Clinton in enhancing customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customers, and applicable statutory and regulatory requirements. All areas of Bio-Clinton’s business fulfill their obligations and adhere to the official standards.

Additional Quality Information


Suppliers

Bio-Clinton will only purchase products from specifically approved plants that meet our strict guidelines for quality. We regularly visit our suppliers to evaluate them not only on the basis of ability to deliver satisfactory products on a timely and cost efficient basis, but also on quality system, facilities and equipment system, materials system, production system, packaging and labeling system, and laboratory control system.

Product Quality Improvement

Bio-Clinton will continue our program of regular visits to our suppliers' plants, and will continue to educate them on the quality of product and service required by our customers. Bio-Clinton is uniquely able to do this, as almost all of our sales representatives are technically trained (chemists, chemical engineers, biologists, pharmacologists, etc.) most with in-plant or industrial laboratory experience that allows them to effectively communicate customer requirements to sourcing teams. Bio Clinton will also continue to search for new products, as well as for new sources for products where we feel our existing sources have lapsed in either product or delivery quality, and/or have failed to meet the needs of our customers or markets.

Specifications

Bio-Clinton's policy is to ensure manufacturer's products meet customer's specifications. Any changes to supplier's processes or specifications will be promptly communicated to customers.

Samples

We will only send production quality samples to customers and we will send lab-produced or pilot plant samples only by prior agreement. We will provide pre-shipment and co-shipment samples any time they are required. Samples will always be accompanied by appropriate Occupational Safety and Health Administration (OSHA) labels and Material Safety Data Sheets (MSDS's).

Packaging and the Environment

Bio-Clinton will promote the use of environmentally friendly recyclable packaging by our suppliers. We will endeavor to meet our customers' packaging requirements. Bio-Clinton will only use warehouses and carriers approved to handle chemicals and that have appropriate permits and licenses.

Claims

Bio-Clinton accepts total responsibility for the quality of all products shipped to customers, and is responsible for settling all quality claims. If we send product to a customer that does not conform to specifications we will accept the return promptly, with all charges for our account, as long as we are notified within 30 days of our customer's receipt of goods. Returned goods are always segregated from in-specification goods, in the warehouse, our computer system, and other systems under the Company's control.

Deliveries

We will endeavor to ensure that each package of each shipment has correct labels and supplier lot numbers, and is in compliance with safety and environmental laws. Certificates of analysis for each shipment will be faxed or e-mailed to our customers, or be available on our website, and will include as a minimum, the customer and Bio-Clinton product names, lot number, test results of the specified properties, and any other information that may be required by a particular customer. MSDS's will also be faxed, e-mailed, or will accompany the shipment. In addition, customers can search for Safety Data Sheets via this link SDS. We will notify the customer in advance should we be unable to meet any of these requirements.