The Government Accountability Office (GAO) and the United States Pharmacopeia (USP) asserted in two recent reports that the regulators need to address some of the ambiguities associated with advanced manufacturing to accelerate adoption in the pharmaceutical industry. The GAO further recommended that the US Food and Drug Administration (FDA) should set benchmarks to better measure uptake to this mode of manufacturing.   A USP official discussed both reports, as well as...

Sterile drug manufacturing is a high-risk operation and to manage these risks, drug manufacturers need to “tightly control” a multitude of variables to ensure processes remain in a state of control, asserted Brooke Higgins, a senior policy advisor for global compliance in the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER).   Higgins outlined some of the consequences that can occur when these variables are not controlled, includin...

The federal budget law passed by Congress and signed by the president in late December calls on federal authorities to establish “warm base” domestic manufacturing to respond quickly to demand surges for medical products during a public health emergency.   Section 2401 of the law calls on the Biomedical Advanced Research and Development Authority (BARDA) to work with the US Food and Drug Administration (FDA) to coordinate these efforts.   The law amends Section 319...

The recently enacted ominous spending bill approved by Congress in late December directs the US Food and Drug Administration (FDA) to establish advanced manufacturing centers for excellence and an advanced manufacturing technologies designation program.   The omnibus spending bill was signed by President Biden on 27 December and authorizes $3.5 billion in budget authority for the US Food and Drug Administration (FDA) in FY 2023, a 6.5% increase compared to its 2022 bud...

The International Council for Harmonisation (ICH) announced that “excellent progress” has been made over the past year in advancing guidelines in the areas of pharmaceutical quality, safety and efficacy, including the adoption of the widely awaited guideline on continuous manufacturing (CM).   These achievements were announced on 22 November following its meeting held in Inchon, South Korea. The meeting was held in parallel with meetings of ICH’s ten working groups and...

The US Food and Drug Administration (FDA) accepts a wide variety of applications into its Emerging Technologies Program (ETP), and is not just focused on continuous manufacturing, said Joel Welch, associate director for science and biosimilar strategy in the agency’s Office of Biotechnology Products.   “I think that sometimes there is a misperception that advanced manufacturing is just about continuous manufacturing,” said Welch who provided an update on the ETP at the...

The EU’s eagerly anticipated revision of its good manufacturing practice (GMP) Annex 1 for sterile drug products was released on Thursday after 14 years of development. The revised requirements, which are set to take effect 25 August 2023, govern the manufacturing of sterile drugs made in the EU, as well as imported products.   The revised Annex comes after hints earlier this year that it be out in mid-2022. (RELATED: EU GMP Annex 1 revision to be released mid-year ...

Applicants that used continuous manufacturing (CM) technology to bring their products to market waited less time before approval after submission compared to batch manufacturing products, according to results from a US Food and Drug Administration (FDA) audit published in the International Journal of Pharmaceuticals .   Authors from the FDA Center for Drug Evaluation and Research (CDER) said these manufacturers had a potential estimated increase in revenue due to the ...

The Japanese regulatory system has been recognized as one of the most sophisticated and stringent regulatory systems in the world. The regulatory policies are developed and administered by the Ministry of Health, Labour and Welfare (MHLW), the Pharmaceuticals and Medical Devices Agency (PMDA) executes the policies, and certain authorities are delegated to local governments. Over the last 6 decades, the Japanese regulator has faced many challenges but has kept enhancing the...

Several industry trade associations are asking for more clarity on the International Council for Harmonisation’s (ICH) Q13 guideline on continuous manufacturing, including what constitutes a state of control for a continuous manufacturing process, the scope of the guideline, and the definition of a batch size. One manufacturer said the guideline places too much emphasis on non-conforming material, which has not been a significant issue in continuous manufacturing.   Th...

Data integrity remediation is a critical activity performed by analytical laboratories, quality control laboratories, and manufacturing plants to comply with good manufacturing practice (GMP) and data integrity requirements. There are various challenges during this activity, and current GMP (cGMP) facilities struggle to comply due to technical limitations and resource constraints. This article examines the data integrity remediation challenges faced by cGMP facilities and ...

The US Food and Drug Administration’s (FDA’S) efforts to encourage the industry’s adoption of advanced manufacturing is bearing fruit, according to a new update from the agency, noting robust interest from industry in participating in the agency’s Emerging Technologies Program (ETP).   In addition, “significant funding” from Congress has helped fund more research in advanced manufacturing, wrote Michael Kopcha, director of the Office of Pharmaceutical Quality in the FD...