The Importance of Pharmaceutical Labelling Compliance

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The Importance of Pharmaceutical Labelling
Compliance
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• Impacting every single process and every minute
  component of the production of pharmaceutical
  products, validation and compliance extends to
  machines, systems, equipment and computer
  systems. Documentation forms a significant
  element of the compliance process, and
  pharmaceutical companies typically require
  integrated support for this, with clarity and
  100 traceability.
• In modern pharmaceutical supply chains, the
  printer is at the end of the validation and
  compliance process, but is no less important than
  any other element. With the complexity and speed
  with which regulatory compliance is growing, and
  an industry shifting towards last-minute
  production processes, no company can afford to
  omit this final stage, or cut corners in any way.

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• That said, many companies producing
  pharmaceutical goods, have no clue that their
  printer validation packs are not complete and are
  not in compliance with US Food and Administration
  (FDA) regulatory requirements. There are
  significant risks and implications involved with
  any form of non-compliance when it comes to
  pharmaceutical labelling, so its vital that
  organizations ensure their User Requirement
  Specification (URS) adequately cover the final
  stage of the production process labelling.

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• Lets put this in a market context
• GMP, or Good Manufacturing Practice validation
  underpins the safety of pharmaceutical products
  and processes as outlined by the FDA, and adopted
  by regulatory bodies like the European Medicines
  Agency (EMA), and UK Medicines and Healthcare
  products Regulatory Agency (MHRA).
• When an organization is non-compliant, they risk
  incurring a hefty regulatory fine, and damaging
  their brands very own reputation, too. In some
  cases, a company may be forced to temporarily
  cease all production, and then spend thousands of
  dollars remediating the situation. Non-validated
  systems and processes have the potential to cause
  significant damage to a company in more ways than
  one, hence it pays to have GMP validation from
  the outset.

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• What documentation is associated with
  pharmaceutical validation?
• Its essential that each and every step in the
  entire manufacturing procedure is validated to
  perform as required under certain, defined
  conditions, and the documentation associated with
  this includes the following
• SOPs or Standard Operating Procedures
• Specifications
• VMP or Validation Master Plan
• Qualification protocols and reports
• Validation protocols and reports

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• The importance of labelling and label printing in
  the validation process
• Vital components of the pharmaceutical validation
  process, labelling and printing issues have been
  the cause of many medical device recall events,
  and responsible for the return of over a million
  units. It takes just one stray label,
  instructions for use or printing error to cause a
  product to be recalled, at huge expense to the
  pharmaceutical company. If a faulty print ribbon
  has caused the contents of a label to become
  unreadable or open to misinterpretation, and the
  product reaches the supply chain before the error
  is detected, not only will regulations have been
  breached, but the safety of patients is at risk.

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• How can suppliers ensure system validation?
• Proactiveness is key when it comes to
  guaranteeing system validation, and everything
  must be checked, checked, and checked again. Risk
  assessments must be provided and a test strategy
  devised, along with following good document
  standards and implementing a high level of
  training protocols.
• An expert trained in Good Automated Manufacturing
  Practice (GAMP) will be able to help suppliers to
  achieve exactly what is needed for appropriate
  validation in a pharmaceutical production
  environment, including validating any extra
  systems integration, such as labelling or
  Enterprise Resource Planning (ERP).

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• It pays not to leave anything to chance when it
  comes to compliance of pharmaceutical validation
  processes, and working with a third party such as
  a reputed life sciences organization, can help
  ensure that your processes and end products, hold
  up under scrutiny.
• Agile scientific Group in Columbus OH 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.