North America Manufacturing, Packaging & Detailing

Both prescription and over-the-counter (OTC) drugs must be manufactured in accordance with standards established by the Food and Drug Administration (FDA). The agency inspects manufacturing facilities before a drug application can be approved. Any manufacturing deficiencies found would need to be corrected before approval.

Current Good Manufacturing Practices (cGMPs) refers to the regulations enforced by the FDA. The cGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities.

Adherence to the cGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories. This formal system of controls at a pharmaceutical company, if adequately put into practice, helps to prevent instances of contamination, mix-ups, deviations, failures, and errors. This assures that drug products meet their quality standards.

The cGMP requirements were established to be flexible in order to allow each manufacturer to decide individually how to best implement the necessary controls by using scientifically sound design, processing methods, and testing procedures. The flexibility in these regulations allows companies to use modern technologies and innovative approaches to achieve higher quality through continual improvement.

• Use of RFID in serialized unique packaging numbering to authenticate and check for recall/expiry status.
• Use of X-ray and metal detection systems to detect glass, stone, bone, rubber and other contaminants
• Use of checkweighers and sorters
• Use of baggers capable of handling, opening and sealing bags manufactured from specialist sterile films and papers.
• Use of quality control labeling systems

It is important to note that cGMPs are minimum requirements. Many pharmaceutical manufacturers are already implementing comprehensive, modern quality systems and risk management approaches that exceed these minimum standards. This is important because a consumer cannot detect through smell, touch, or sight if a drug product is safe or if it will work.