As times change so do the expectations of the regulators. This holds true with validation as well. More global health authorities and regulators are communicating their expectations for risk and science based justification for process control and validation approaches. Let’s take a quick look at how the definition of Process Validation has evolved:
Pointillism is a technique of painting using tiny dots of various pure colors, which become blended in the viewer’s eye when seen at a distance. It was developed by George Seurat with the aim of producing a greater degree of luminosity and brilliance of color. Alone, each colored point on the canvas is just that and only that. It is only when these colors are properly grouped together does the picture make sense.
A dosage form is the form in which a drug is produced and dispensed; for example, tablet, capsule or suspension. The rate and extent to which the amount of drug substance dissolved over a period of time is called dissolution. Dissolution testing is the primary pharmaceutical test that is designed to probe the performance of dosage forms. The dissolution method developed is compared with the innovator’s reference product to evaluate the release pattern and establish the method comparison for estimating the drug release. The purpose of this article is to provide some insight into the comparison of dissolution profiles using f2 analyses.
What is a Pre-Approval Inspection? For pharmaceutical companies, this FDA inspection is intended to determine whether their facilities, manufacturing processes and controls used to produce and package drug products are adequate to ensure the safety and quality of their products. The FDA wants assurance that problems that arise during the drug manufacturing process are investigated properly and that quality systems are in place to document and remediate these issues in a timely manner.
For programmers who analyze clinical trial data in the pharmaceutical and biotechnology industries, the Standard Data Tabulation Model (SDTM) is incredibly important and valuable. Prepared by the Submission Data Standards (SDS) team of the Clinical Data Interchange Standards Consortium (CDISC), the purpose of SDTM is to organize, structure and format standard clinical trial tabulation datasets submitted to regulatory authorities such as the US Food and Drug Administration (FDA).
Given the lightning pace of business at medical device, pharmaceutical, and biotechnology firms these days, it’s no wonder that more and more companies seek talented, experienced consultants who can quickly ramp up to work on critical projects. EG Life Sciences partners with life sciences companies to locate top talent to meet this demand and works closely with consultants to match them to these opportunities.
In Deloitte’s 2016 Global Life Sciences Sector Outlook, the research points to “an ever-evolving regulatory and risk environment” coupled with the “growing prevalence of chronic diseases” as just two of the factors driving the growth of the biotech sector and the heightened need for skilled Life Sciences professionals.
When the FDA comes in to inspect a pharmaceutical or biotechnology company’s manufacturing facilities they can either alert the company ahead of time or show up unannounced. After the inspection is over the FDA can send what is called an FDA form 483 or a warning letter. There are differences and various consequences depending on how these are both handled.