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.
Explore tech transfer expert Anthony Grenier's opinions on the most common mistakes he sees, how to avoid them, and planning ahead to beat the CMO capacity crunch.
Though a majority of the data points in a recent ISR report on Sterile Manufacturing are not specifically focused around biosimilars, I reached out to the report’s lead author to unpack a handful of findings I thought would be important for those involved in both biologics and biosimilar manufacturing and outsourcing.
Americans' view of the pharma industry is at an all-time low. NSF Health Sciences Global VP Martin Lush says to change that, something radical will have to happen.
Pharma's CMC regulatory affairs staff, R&D leadership, manufacturing, quality and compliance professionals take note: the EU MDR is real, it becomes effective next May, and it brings with it new challenges and regulatory uncertainty for manufacturers of combination products.
While some regulators may express skepticism that we’ll see major changes to the clinical component of the biosimilar development pathway, Woodcock’s DIA keynote exemplified what I found to be a strikingly different attitude about the future possibilities for biosimilar development.
With minimal specific guidance on commercial manufacturing from the FDA and a lack of robust platform commercial processes, some of the finer details of cell and therapy manufacturing can make operating companies feel like they are walking on a precarious limb.
The EU has approved 16 biological molecules, and the U.S. has licensed the same molecules (including approving some as 505(b)(2) approvals), except for follitropin alfa, which amounts to 114 biosimilars, combined. This article, based on the EMA’s European public assessment reports (EPARs) and the FDA’s BLA (biologics license application) reviews, identifies many inconsistencies that require revision of regulatory guidance to assure faster approval of biosimilars.
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.
Learn the statutory and regulatory requirements for interchangeability designation, how the designation hampers follow-on biologics, and why the FDA should loosen requirements for the designation.
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.
Compared to small molecules, large molecules generally require special handling procedures for the bulk drug substance, formulation, and sterile filtering and filling of the final drug product, which is forcing changes at nearly every level of the manufacturing process.
This whitepaper discusses cleaning of affinity resins intended for use in the purification of monoclonal antibodies and antibody fragments.
Appropriating BPOG testing on single-use connectors to mitigate the risks of E&L, as demonstrated in this article, is crucial to delivering safe and effective drugs.
Size exclusion chromatography (SEC) is the go-to analytical method in the analysis of therapeutic protein drugs. This article describes the factors affecting the reproducibility of columns and how you can minimize column variation.
- Clinical trial sponsors and clinical supply vendors must fully consider all attributes of their supply chains to ensure continuity of supply post-Brexit. This whitepaper outlines many questions that sponsors and vendors alike should ask
Despite tremendous growth, drug makers still face a number of challenges in the manufacturing process for antibody-drug conjugates (ADCs). Here are key areas where pharma faces uphill battles.
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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