ropack articles

  1. What Does The Deferment In The DSCSA Deadline Enforcement Mean For You?

    Determine your plan now for serialization readiness to put the worries of DSCSA costs and timelines behind you and patient safety back where it belongs — at the forefront.

  2. Pharmaceutical Serialization: Is Your Data Management System Ready?

    The FDA’s intent to not enforce the requirements of the Drug Supply Chain Security Act until November 2018 offered an additional year meet compliance. The deadline for that grace period is now!

  3. A Bridge Over Troubled Water: The Journey To Serialization Compliance

    This regulation from the FDA outlined serialization and traceability requirements spread over the course of 10 years with preparation for each phase accumulating into a potentially high overall price tag.

  4. The 3 Cs You Should Expect From Your Pharma Service Provider

    When asked about the biggest challenges to the pharmaceutical company sponsor-contract service provider relationship, sponsors and service providers offer pretty consistent responses.  

  5. US Clinical Labels 101: Steps To Ensure Accuracy

    Determining a drug candidate’s probability of commercial success is a most significant phase in the drug development process. There is no room for error.

  6. Embrace Quality Risk Management To Build A Strong Quality Culture

    Using QRM gives a company the ability to maintain compliance while also identifying product issues that could be harmful to the consumers, some being susceptible patients.

  7. Quality Metrics: How To Add Value And Meet The FDA's Expectations

    Quality metrics have been widely used in the pharma industry to monitor quality systems, operational processes, and to promote continuous improvement initiatives in drug manufacturing. 

  8. Understanding Quality Agreements Between You And Your Service Provider

    An effective quality agreement icommunicates the responsibilities of each party in a clear, concise manner, allowing the reader to quickly and accurately determine to whom a specific responsibility is assigned. 

  9. A Cost-Effective Approach To Cleaning Validation And Verification

    A pharmaceutical contract services organization encounters many compounds at different phases of development and varying customer requirements. From fully developed large scale manufacturing and packaging to a single development batch, the contract services organization must be prepared to handle multiple compounds in the same facility.

  10. The Role Of Pharmaceutical Packaging Partners In Times Of Growth

    The expanding global pharmaceutical industry projects a 4%-6% annual growth and forecasts that it will reach a value of $1T by 2014. By Paul Dupont