Quality Systems

Bringing in external expertise may be necessary when internal knowledge is lacking, but it is critical that any contract employee or consultant is comprehensively assessed to ensure the right person is employed.

Pharmaceutical Technology® spoke with Krishna Kanumuri, CEO of Sai Life Sciences, about which trends from 2024 will carry over and impact the bio/pharma industry in 2025.

Josh Hoerner, general manager of Purisys, provides his perspective on FDA’s recommendations for acceptable intake limits for N-nitrosamine impurities.

New TCR-T cell therapies look promising in the treatment of haematological and solid tumours.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.

The Act is the European Union’s plan to avert drug shortages.

Christian Cobaugh, Eswar Iyer, and Vincenzo Antignani go behind the headlines to discuss a mixture of investment trends, policy realignments, trade and stock recalibrations, and an apparent crusade against vaccines both new and old.

Martin A. Makary, confirmed by a bipartisan vote of the US Senate, has been sworn in as FDA’s new commissioner.

William Wainwright, business development manager at Iwata Label USA, discusses the practical security benefits of functional labels at INTERPHEX 2025.

The Omni ASCENT, officially launched at INTERPHEX 2025, is a next-generation off-site manufactured vertical utility solution aimed at optimizing the flexibility and efficiency of cleanrooms.

Pharmaceutical Technology® spoke with Will Gordon, senior vice president of Product Management, ArisGlobal, about how the geopolitical instabilities might impact the bio/pharmaceutical industry.

Marks called out an ‘assault’ on truth and science in his resignation letter, which has sent the bio/pharmaceutical industry reeling.

Pharmaceutical Technology® spoke with Alexander Seyf, CEO and co-founder of Autolomous, about which trends from 2024 he expects to impact the bio/pharmaceutical industry in 2025.

Pharmaceutical Technology® spoke with Will Gordon, senior vice president of Product Management, ArisGlobal, about the impact of artificial intelligence and machine learning on the bio/pharmaceutical industry.

Three of the five are biosimilars, and seven additional medicines received recommendations for indication extensions.

Sherwin-Williams’ advanced coating systems are designed to ensure safety, sterility, and efficiency in pharma manufacturing environments.

In this exclusive Drug Digest video interview John McQuaid from Almac Pharma Services and Sridevi Khambhampaty from Shilpa Biologics delve into the evolution of the bio/pharma outsourcing market and look at how service-providers’ strategies have adapted to meet demand.

In the latest of a series of warning letters to India-based API manufacturers, FDA issued a warning letter to Aspen for deviations in CGMP in the production of APIs.

In response to a presidential Executive Order, the Department of Health and Human Services is planning to reduce its workforce, including cutting FDA staff by 3500 full-time employees, and reorganize some key departments.

The company’s state-of-the-art sterile drug product manufacturing site in Saint-Beauzire, France, opened in February 2023.

The contract will support R&D of high-quality APIs for substance use disorders and mental health conditions, starting with synthesis and scale-up of psilocybin, which is derived from mushrooms.

Fabhalta (iptacopan) received a positive opinion for treatment of C3G from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and has been approved twice before by FDA.

The EU medicines agencies’ network strategy, EMANS, is an update of the five-year strategy previously developed to cover the period 2021 to 2025.

Dirk Margosch, Vice President Visual Inspection, Assembly & Secondary Packaging at Vetter Pharma-Fertigung GmbH & Co KG, provides advice on final product inspection for small batch sizes. He also discusses how to maintain cold chain during visual inspection.

Pharmaceutical Technology® discusses the quality and compliance issues surrounding the use of animal-derived ingredients in the bio/pharma industry with Roger Viney, chief commercial officer of ICE Pharma.

The certification allows Benuvia to produce pharmaceutical products for companies, either local to Brazil or international, that may be looking for compliant and high-quality production capabilities in the Brazilian pharmaceutical market.

Miguel Forte from ISCT and Kiji Therapeutics provides his insights into the changing political landscape in the US as well as legislative and regulatory adjustments, in an interview with Pharmaceutical Technology®.

The ‘full tolerance coverage method’ is introduced as a coverage estimation approach for assessing the uniformity of dosage units from large sample sizes, ensuring that no dosage unit exceeds the specification range.

Being fully versed on the ins and outs of design quality can improve the project design phase life cycle.

The alterations are the result of an agency review of findings from a clinical trial, and data from required postmarket studies.