Regulations Affecting the Life Sciences Industry
Life sciences organizations need to address a broad range of industry-specific regulatory issues in addition to standard corporate governance, risk, and compliance demands. Regulatory compliance is a core part of life science industry, ensuring a competitive supply chain, promoting customer confidence and enabling profitable growth.
The United States Food and Drug Administration is a public health agency that protects consumers by enforcing the U.S. Federal Food, Drug, and Cosmetic Act. The FDA regulates over $1 trillion in products including:
- Food for human and animal consumption.
- Pharmaceuticals consisting of ethical, generic, and over-the-counter (OTC) drugs for human use, as well as medicine for animals.
- Biological and related products including blood, vaccines, and biological therapeutics.
- Medical devices
- Radiation emitting devices such as microwaves.
The FDA monitors the manufacture, import, transport, storage and sale of these products by businesses that conduct business in the United States. Compliance with FDA regulations has become a market requirement. Failure to comply can be very costly, not only due to expensive recalls, but the FDA is empowered to even seek criminal penalties against those who don't comply.
GMP, sometimes referred to as "cGMP", or "current Good Manufacturing Practice" describes good practices for the manufacturing of pharmaceuticals. They are a set of regulations specified by the FDA. They describe mechanisms for the control and management of pharmaceutical manufacturing processes, including, but not limited to, quality control mechanisms.
Similar to the regulations put forth by the FDA, the European Medicines Agency, part of the EU, has passed regulatory requirements (Annexures 11, 13, 14, 16, and 18) that also cover computerized systems for the life sciences industry, manufacture of medical products, and certification of products to be released.
Regulatory Challenges for Life Sciences
Electronic Records and Signatures
SAP solutions provide the functionality required to comply with the following regulations and guidelines related to electronic health records and signatory capabilities.
This directive specifies legal requirements for good manufacturing practice (GMP) in the European Union (EU). It requires that data be available at the proper time, provided in a readable form, and protected against damage or loss.
International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use Q7A provides guidelines for active pharmaceutical ingredients in the EU, the United States, and Japan. Q8 provides guidance on pharmaceutical development and Q9 covers quality risk management for all aspects of pharmaceutical production.
The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme (PIC/S) develops and promotes harmonized GMP standards and guidance documents; training competent authorities, in particular inspectors; assessing (and reassessing) inspectorates; and facilitating the co-operation and networking for competent authorities and international organizations.
This U.S. FDA regulation establishes requirements for electronic records systems, regulating the use of computer systems, audit trails, lot and serial traceability, change control, archiving, e-signatures, and security.
Radio Frequency Identification (RFID)
SAP solutions provide the functionality required to comply with the following regulations and guidelines related to radio frequency identification (RFID).
Specifies the FDA rules and requirements for bar codes on most prescription drugs and certain over-the-counter drugs.
The European Commission has established procedures for the rapid transmission of information related to pharmaceutical recalls.
This FDA Compliance Policy Guide describes how the FDA intends to enforce regulations related to labeling, electronic records, and product quality for pharmaceutical manufacturers, re-packers, re-labelers, distributors, and retailers.
US State Regulations - There are a number of US states that have established or are establishing mandates that require pharmaceutical wholesalers and distributors to maintain pedigrees for every drug shipped within their borders. Florida is one of the states developing such legislation.