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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.

U.S. Food and Drug Administration (FDA)     

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.  
  • Cosmetics

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.

FDA Regulation Title 21 Parts 210/211- Good Manufacturing Practice (GMP)  

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.

European Union GMP  

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.

EU Commission Directive 2003/94/EC (EU GMP Guideline)  

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.

ICH Q7A, Q8, Q9 Guidelines  

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.

PIC/S  

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.

FDA Regulation Title 21 CFR Part 11 – Electronic records, Electronic Signatures  

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).

FDA Bar Code Label Requirements for Human Drug Products and Biological Products  

Specifies the  FDA rules and requirements for bar codes on most prescription drugs and certain over-the-counter drugs.

Procedure for Handling Rapid Alerts and Recalls Arising from Quality Defects  

The European Commission has established procedures for the rapid transmission of information related to pharmaceutical recalls.

Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs  

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.

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