Even after this extensive qualification process, pharmaceutical companies periodically conduct supplier audits on key aspects of the supplier's quality processes to ensure these quality systems are adhered to.  Pharmaceutical companies prefer to do business with like-minded suppliers.  The partnership that develops ultimately results in packaging that meets the demanding standards of the industry.

Current Good Manufacturing Practice (cGMP) - All aspects of Winpak Control Group's operations are governed by our commitment to assist our customers to fully comply with FDA cGMP regulations.  Our commitment supports customers in meeting their required obligation with the FDA and benefits other companies, even those not regulated by the FDA.  The "c" for "current" in cGMP reminds manufacturers that they must employ technologies and systems that are up-to-date in order to comply with the regulation.

Promulgated by the US Food and Drug Administration under the authority of the Federal Food, Drug, and Cosmetic Act, GMP regulations, which have the force of law, require that manufacturers, processors, and packagers of drugs, medical devices, and some food products must take proactive steps to ensure that their products are safe, pure, and effective.  GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mix-ups, and errors.  This in turn protects the consumer from purchasing a product that is not effective or even dangerous.

GMP Regulations address all areas of our business operations including record keeping, personnel qualifications, sanitation, cleanliness, equipment and process validation, and complaint handling.  Most GMP requirements are very general and open-ended, allowing each manufacturer to decide individually how to best implement the necessary controls.  This provides flexibility, but also requires that the manufacturer interpret the requirements in a manner that makes sense for each individual business.

US FDA & Canadian Approved Drug Master Files
A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) and the Canadian Therapeutic Products Directorate that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.  Law or FDA regulation does not require the submission of a DMF.  A DMF is submitted solely at the discretion of the holder.  The information contained in the DMF may be used to support an Investigational New Drug Application (IND), a New Drug Application (NDA), another DMF, an Export Application, or amendments and supplements to any of these.