8 Constraints to Achieving Excellence in Pharmaceutical Packaging and Labeling

Has your company had a product launch or production delayed because of packaging or labeling issues?

Identifying the common constraints to achieving excellence can help you restructure your plan around it. By focusing on alleviating these constraints, you can speed up the process and accomplish goals faster.


This article identifies 8 constraints to achieving excellence in pharmaceutical packaging and labeling.

  1. Constraint #1: Not keeping up-to-date with the constant changes
  2. The quest for excellence is a never-ending journey. The world is in constant change. Regulations are evolving. Up-dated Training programs by industry experts in pharmaceutical packaging and labeling can go a long way in helping you keep up-to-date with the constant changes.

    Take the example of The DSCSA (Drug Supply Chain Security Act) which sets out serialization and track and trace requirements for the US drug supply chain. It impacts the entire operations. Subsequent DSCSA deadlines will impact wholesale distributors (November 2019) and dispensers (November 2020). From 2023, full unit level traceability including aggregation will be mandatory. Not being up-to-date can catch companies unaware and can lead to enforcement actions by the regulatory agencies.

  3. Constraint #2: Underestimating the importance of packaging and labeling in the planning phase
  4. The importance of packaging and labeling is often underestimated at the planning phase. This leads to needless increases in cycle time, costly mistakes, and delays in product availability or product recall because of not complying with the regulations.

    Great care should be exercised to ensure factors such as correct drawings, enough lot/expiration area, safe ink usage, insert paper grade, proper carton folding lines, proper colors, right spellings, font usage, secure electronic transfer from company to printer and a host of others.

  5. Constraint #3: Not considering or understanding patient needs
  6. Patient-friendly features are not only essential to achieving excellence in packaging and labeling but are also crucial to the success of the product. FDA requires that the patient labeling to be evidence-based. It should be accurate and written in a language that the average patient can comprehend.

  7. Constraint #4: The extreme pressure to maintain an ever-increasing regulation and legislation
  8. Packaging and Labeling recalls are rampant. There is greater regulatory scrutiny by the FDA and other regulatory agencies. Top reasons for Packaging and Labeling product recalls include defective containers, missing lot numbers, label mix-up, and label error on declared strength. Packaging and Labeling activities are crucial for compliance with regulatory agency requirements.

    Labeling regulations differ by country and region. Companies must take steps to understand these regulations and develop systems to accommodate global requirements. The best approach to get acquainted is to attend training programs on the applicable regulations.

    Examples of regulations on packaging and labeling include:

    • Subpart G of 21 Code of Federal Regulations Part 211
    • 2013 Drug Supply Chain Security Act

  9. Constraint #5: The conflicting demands of different stakeholders
  10. Stakeholders generally have different demands. Balancing between demands such as cost and attractive packaging, easy to open and childproof isn't simple. Using data to back up your planning, strategy and decisions is the best solution to this constraint.

  11. Constraint #6: Resistance to change
  12. Packaging and Labeling tools are evolving. This calls for new ways of working. The real challenge is to get people to understand the new value and have them embrace the change.

  13. Constraint #7: The high cost of packaging materials and tools
  14. Although there are excellent materials and tools available, many Pharma companies do not choose them due to their high cost.

  15. Constraint #8: Poor alignment within the organization before implementing changes
  16. Before making Label changes, it is important to develop the requirements correctly. However, many pharmaceutical companies rush into the program without investing time into the requirement development process.

    Packaging and labeling play a crucial role in the success or failure of any pharmaceutical product launch. It forms a link between the conception of a product, its realization, and distribution. With the regulatory agencies increasing their scrutiny, companies must check if the common constraints specified in this article exist within and pay greater attention to ensure compliance.

    Recommendations to overcome the common barriers

    • Work collaboratively between all your functions to understand each other's needs
    • Combine flexibility with automation, integration, and creativity
    • Consider packaging and labeling as important in the planning phase and have strategies in place to optimize the process
    • To minimize complexity, harmonize all the components of packaging in terms of leaflets, custom box, bottles, etc.

    Next steps if the following areas are of interest to you in your current job function

    It is important for you to get deeper insights into:

    • Regulatory Agency Requirements
    • SOPs and Change Control considerations related to packaging
    • Packaging and Labeling Interactions
    • Creation of the Package
    • Codes
    • Packaging Errors
    • Labeling Errors
    • Supply Chain Issues

The above areas are covered in the seminar 'Packaging and Labeling in Pharmaceutical Production'. Attend this seminar to take a deep dive into the topic.

The speaker is Michael Esposito. has over 30 years experience in the pharmaceutical industry and 17 years experience in GMP training and document management. He has worked for Wyeth Pharmaceuticals, Pfizer and Johnson & Johnson's Consumer Healthcare Division in a variety of areas including Packaging, project administration, Quality Assurance, Government Contracts, translations, systems training, and international operations. He collaborated in the development and implementation of the training portion of the Consent Decree workplan for Johnson & Johnson Consumer Healthcare and revised their introductory GMP course. He is a member of the training organizations GMP Training Educators Association and Association for GXP Excellence, and is fully fluent in Spanish. His areas of interest include systems training, training effectiveness, post-training user support, process improvement, product security, and sustainable packaging.