What regulations Affect the Life Sciences Industry?

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What regulations Affect the Life Sciences
Industry?
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• 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

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• 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

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• 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 dont
  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.

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• 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.

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• 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.

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• 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.

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• 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).

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• 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.

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• 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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• Agile Scientific is a life sciences organization
  that brings decades of industry knowledge,
  expertise, processes, best practices, and systems
  to companies. Agile Scientifics clinical
  services function to accelerate all facets of
  drug development, ensure compliance at a global
  level and optimize pipeline value / ROI. Agile
  Scientific Group LLC is fortunate to partner with
  smaller virtual organizations and Fortune 500
  Life Sciences companies alike. We have extensive
  experience providing focused, pragmatic clinical
  solutions to our sponsor Life Science
  organizations and CROs across all areas of Drug
  Safety, Regulatory Affairs, HEOR /
  Pharmacoepidemiology, Quality Assurance.