As we discussed in our previous review of humorous and horrifying events we actually witnessed in pharmaceutical facilities, “Pigeons In The Plant: 10 Real-Life Pharma Facility Blunders (And How To Avoid Them)”, our industry is flawed like any other. The examples in this follow-up article relate more to the engineering side of the business — what we do, what we tell others, and the culture we create.
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.
Biocompatibility is an essential element for any pharmaceutical combination product. ISO 10993 is the standard for biocompatibility, and it is broken into various normative sub-standards from ISO10993-1 to -22 that focus on various assessments, considerations, recommendations, and approaches.
Part 1 of this series provided an overview of CPV and how it is key to setting the foundation for continuous improvement in pharmaceutical manufacturing. In this second part, we will look more deeply into how enhanced knowledge management can enable robust change management in the life sciences industry.
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.
While the boipharmaceutical industry has benefited from high margins and low competition for decades, operational efficiency remains a low priority item for packaging departments in life sciences..
Process validation should never be performed until the process is fully characterized. A failed process validation should be a rare event; otherwise, a Warning Letter will probably be in your future.
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.
New product types and packaging configurations, such as highly viscous formulations, pose a threat to traditional leak-testing methods, challenging current practices for container closure integrity testing.
This white paper presents some ideas for selecting the right inline high shear mixer for your process based on a company’s collective experience as a mixing equipment provider to process industries.
This article explains the differences between validation, verification and routine performance monitoring and gives an overview of recommended test methods for different metal detection systems.
This whitepaper discusses the importance of understanding how critical process parameters can impact a product’s critical quality attributes, and how a systematic approach with validated SPR assays can help in this respect.
One of the major challenges in batch mammalian cell clarification is cost-effective improvement in filtration in the face of high cell densities.
While there are “bad” fume hoods, anything wrong with the entire system (exhaust fan, ductwork, building configuration, regulative dampers) may cause a lack of containment in a hood.
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.
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