A comprehensive GMP intelligence program includes monitoring of health authority enforcement actions, including FDA Form 483s, Establishment Inspection Reports, warning letters, recalls, import alerts, consent decree agreements, and EU reports of GMDP noncompliance. This article presents the most recent publication of GMP drug inspection data from CDER, which addresses drug inspections conducted in FY2019. The FDA published data from FY 2018 in September 2019 and we recently addressed that data; FY2019 data was published on Nov. 15, 2019. Here we examine data from FY2019, along with seven years’ worth of trends in drug GMP inspections.
The clock is ticking for state lawmakers to preserve an existing law that allows for prescription drug coupon usage in Massachusetts with an end-of-the-year deadline fast approaching.
This article focuses on efficiency initiatives, providing some insights on how to better use overall equipment effectiveness (OEE) tracking systems and how to avoid common mistakes.
Process characterization is the foundation for process validation activities. Too often, validation activities fail due to the lack of process characterization using sound statistical and scientific methods, including design of experiments (DOE).
HR changes continually impact overall data integrity—from a single new hire to a corporate-level change with a merger or acquisition. It's a commonly overlooked weak link in the data integrity chain.
There are situations we have come across where we really scratch our heads and say, “What did they just do, and what were they thinking?” This article describes a series of events and activities that we have seen that are at once amusing, baffling, and revealing of the flaws in our industry.
When faced with scenarios that demand SOP remediation (outsourcing, mergers, acquisition), repurposing processes, written content, templates, etc., can be the worst possible and most expensive approach when you factor in time, human resources, and long-term outcomes.
Does the pharmaceutical industry want to sit on the sidelines while its products are being manipulated and modified — a danger? Or will the industry provide its products in a manner or with the tools that will enable compounding pharmacies to succeed in delivering a safe and effective drug to the patient — an opportunity?
Engaging QPs well before the clinical trial material needs to be certified not only assures a smooth release process and trial start-up but mitigates pitfalls associated with unanticipated challenges.
This article outlines six recent regulatory changes in China intended to protect patient safety as well as reduce regulatory burdens and minimize delays.
A significant concern in tablet manufacturing is speed to market. Moving too quickly, however, may cause delayed production, lost product, and missed deadlines. To reduce potential headaches, companies are embracing the principles of Quality by Design (QbD) and utilizing automated data gathering and tablet analysis during research and development. This allows organizations to reduce product development and delivery stress and loss.
In today’s changing industry, it is critical we consider several factors about cell culture bioprocessing and the impact they will have on the future of patient treatment.
This paper includes a discussion on vaccine processes, followed by a case study on the scale-up of upstream and downstream processes for the production of a cell-based live attenuated influenza virus using single-use ReadyToProcess technology.
A non-invasive, non-subjective solution that is capable of detecting package leaks and invisible defects using a differential pressure transducer leak test system.
Pharmaceutical parenteral delivery systems are the highest risk packaging application concerning container closure integrity. Leaks that register in the single micron range can introduce a significant threat of bacterial ingress as shown in research by Kirsch et al. in 1997. To manage this risk, the industry has continued to pursue leak detection methods that are more sensitive and reliable for vials, ampoules, cartridges and syringes.
This free collection of articles is from the Data Integrity In The Life Sciences series, the purpose of which is to highlight contemporary insights and relationships to key quality systems in order to elevate the most important topics and advance improvements in the collective quality culture.More Content Collections