The estimated timeline for a drug product from discovery to market is 10 to 15 years. However, less than 12 percent of drug candidates that enter clinical trials will ultimately receive FDA approval. The Orphan Drugs Act of 1983 ensured that there were adequate incentives offered to drug developers working on therapies to treat fewer than 200,000 patients in U.S.
Contamination control activities aim to permanently ensure a sufficient level of cleanliness in controlled environments. This is accomplished by maintaining, reducing, or eradicating viable and non-viable contamination for sanitary purposes or to maintain an efficient rate of production.
If you are charged with any of the tasks that lead to a successful product launch in the pharmaceutical industry, you know how critical it is to execute a multitude of steps successfully. Among these are agreement by marketing on the look and design of the campaign, completion of clinical trials, project management, testing of active pharmaceutical ingredients, the completion of a trial production batch, receipt of all materials at the production site, production scheduling, regulatory agency submissions, trademark registration, and a host of others.
Microbial control for non-sterile manufacturing helps to ensure the safety and efficacy of pharmaceuticals. Products that are compromised with excessive amounts of microorganisms, specified microorganisms, or objectionable microorganisms may not be effective or could be dangerous to consumers. Unfortunately, the regulations governing non-sterile manufacturing are not as clear or as abundant as those for sterile manufacturing. This leads many manufacturers to utilize risk assessment analysis tools to adapt portions of sterile manufacturing guidelines when developing environmental monitoring programs for non-sterile environments.
There is a trend within the pharmaceutical, biopharmaceutical, medical device, and vaccine industries to hire more consultants, leading to a staffing ratio that can be up to 50 percent consultants to staff for small to large capital projects.
Probably the biggest concern for anyone implementing, deploying, and maintaining a quality management system (QMS) is the integration of risk-based thinking. While the concept of risk management is not new, previous practice was more reactionary, primarily focused on detection after the fact, root cause analysis, corrective actions, and preventing recurrence of the failure. Contemporary thinking places the emphasis on considering risks up front (prevention) and having a solid approach to address risk in planning, managing, and driving actions.
Manufacturers of sterile products must engage in critical thinking, asking “Why?” and “Why not?” questions, challenging and pushing the industry towards more effective means of quality and process control. In this way, we can ensure that we are prepared to meet the challenges of providing sterile pharmaceutical products that are not only safe and effective, but also are available and affordable for the patients who depend on them.
While other industries have learned from the principles of quality and statistical control methodology, (bio)pharma has been slow on the uptake. This article proposes tactic designs that utilize collaboration tools to facilitate Kaizen/continuous improvement in quality management systems (QMSs).
Pharmaceutical companies face many challenges: developing life-changing products that meet the needs of patients, physicians, and payers; adhering to regulatory standards; and managing health technology and payer scrutiny, all while trying to satisfy investors. As drug prices seem to be continually rising, many health plans are shifting more of the cost-sharing burden to patients. As a result, the patient is becoming more of a “consumer” in the traditional sense.