Guest Columns

  1. An Introduction To Analytical Instrument Qualification & Validation — Meeting FDA Expectations

    According to the FDA and other regulatory agencies, analytical instruments should be under the same strict control as manufacturing equipment. Analytical instruments provide critical scientific data about a manufactured product. This data ensures confidence that a quality product has been manufactured and is appropriate and safe for sale to the public. Therefore, as manufacturers, we are bound to ensuring all of our equipment is strictly controlled. Analytical instruments must be qualified, just as manufacturing equipment. We have to show consistency, reliability, and repeatability to ensure the quality of the drugs we produce. The FDA's findings of deficiencies concerning analytical instrument qualification indicate it expects definitive evidence that instrument qualification schedules satisfactorily control manufacturing processes as well as testing processes.

  2. Rapid Growth In Life Science Sector Constrains Capital Projects Supply Chain

    According to the latest PharmSource Trend Report, Bio/Pharma CapEx Trends 2016, biopharma companies have invested over $150 billion in new plants and equipment in the past five years. As this sector continues on an upward trend, it is placing significant pressure on the supply chain. Mother Nature in California, Texas, Puerto Rico, Mexico, and Southeast Asia and Amazon’s much-anticipated HQ2 serve as further reminders to plan for mitigating cost and schedule project impact.

  3. What To Do When Your CMO Overpromises And Under-Delivers

    You have struggled with your CMO for the last six months; slowly, but surely, your requested manufacturing dates for your newly transferred process have edged further and further out. You chose this CMO based on several factors: a capability match, good regulatory history, a passing quality systems audit, a capacity match, and their ability to meet your critical and aggressive timelines. Now, the looming reality is that your critical timeline will not be met, and you are struggling to get a believable commitment from the CMO so you can report back to your own organization.

  4. 3 Tips To Get The Best Bang For Your Mock Inspection Buck

    Many sponsors and CROs conduct mock inspections to determine organizational inspection and audit readiness. Investing in a regulatory mock inspection demonstrates a serious commitment to patient safety, data integrity, and regulatory compliance. It is also a proactive strategy to safeguard financial health, particularly for startups and companies with sparse pipelines.

  5. How To Build A Value-Added GMP Supplier Management Program

    Typically, supplier management programs use a supplier survey or an on-site audit to verify if a supplier is compliant with the requirements of a standard or regulation. However, for a supplier management program to provide added value to an organization, the supplier evaluation should look beyond the requirements of a standard or regulation. A value-added supplier management program should also consider items such as supplier capability, capacity, and contingency planning.

  6. Take A Page From Amazon’s Playbook To Transform Clinical Trials

    Around the holidays, I reminisce about family dinners: three generations under one roof for a few hours, catching up on the past year. My mother presided over the festivities for several decades until her passing. For 10 years, she was a survivor of a rare cancer. She had two surgical resections and treatments before the cancer returned. There was only one approved orphan drug, which was 50 percent effective in decreasing mortality for six months. There weren’t many options in clinical trials and no Internet patient-centric community for information and support.

  7. Why You Should Engage With Regulatory Early In Product Development

    The transition from research to product development is a bit more involved than simply adding “&D” to “R.” Involving regulatory affairs early in the development process facilitates definition and execution of the development pathway while considering both regulatory requirements and the company’s business needs.

  8. Beyond Pricing: Can Biosimilars Compete On Value?

    In recent years, the growth in U.S. drug spending has become a hot-button issue. Data released in 2017 by the pharmacy benefit manager (PBM) Express Scripts illustrates which drugs account for the increased spending. In 2016, spend on so-called specialty drugs, a class that contains many biologics, grew by over 13 percent, while spend on traditional drugs actually declined by 1 percent. Five of the top 10 earning drug therapies in the U.S. in 2016 were biologics.

  9. Tips For Improving Your Batch Record Review Process

    According to the many global regulations, production and control records should be reviewed and any failure of a batch to meet specifications should be thoroughly investigated. The investigation should, if necessary, extend to other batches of the same product and other products that may have been associated with the specific failure.

  10. Cheating In The Lab: 3 Data Integrity Pitfalls To Avoid In Laboratory Operations

    At least 20 percent of all warning letters issued by the CDER Office of Manufacturing Quality in 2017 included explicit observations by inspectors of blatant data integrity violations in laboratory operations. It is incumbent upon us to enforce and reinforce basic CGMP and GDocP practices in our own laboratories and those of our suppliers