Search

Quality culture is a patient-focused approach to quality that is proactive not reactive or procedural, according to Rick Friedman of FDA, in a conference presentation (1). When an organization is [...]

Q: Vario us presente rs a t recent con ferences have me ntioned th e c oncept of 'Quality Culture,' yet we cannot find this term in the applicable regulations [...]

Q: Various presenters at recent conferences have mentioned the concept of 'Quality Culture,' yet we cannot find this term in the applicable regulations and guidances. Can you tell us more? [...]

FDA regulatory oversight and enforcement have never been more intense or potentially more costly. According to the business intelligence firm FDAzilla, the agency is on pace in 2011 to break [...]

Arecent Gallup poll concluded 'Americans are more than twice as likely to rate the pharmaceutical industry negatively as positively.' In an August 2019 Gallup assessment of perceptions of US business [...]

Years ago, a United States congressman visited one of our manufacturing plants in New York. After touring the facility and meeting the highly experienced professionals dedicated to drug development and [...]

The concept of quality culture and how to enforce it are being debated by regulators and industry, says Siegfried Schmitt, vice president, Technical at Parexel. Q: Vario us presente rs [...]

People around the world rely on medicines to improve--and often save--their lives. These therapies must not only be effective, but also safe for people to use. Regulatory bodies offer guidelines [...]

People around the world rely on medicines to improve--and often save--their lives. These therapies must not only be effective, but also safe for people to use. Regulatory bodies offer guidelines [...]

The training function in a pharmaceutical facility is vital to site operations. The objective of training is straightforward; training is responsible for employee learning. Site training programs must be effective [...]

This paper reflects upon the past 15 years of experience in the application of QRM and KM within the pharmaceutical GMP environment. While the concept of risk has been a [...]

In recent months, FDA has begun championing Quality Management Maturity (QMM), a new quality surveillance initiative intended to raise awareness at all levels of management in the pharmaceutical industry as [...]

Over the past decade, auditing of clinical trials evolved to a risk-based model. We took it to the next step by implementing a quality management (QM) approach in our audit [...]

The pharmaceutical industry's investments in the latest manufacturing technologies and quality practices have contributed greatly to assuring the reliable supply of safe and effective drugs. And yet, lingering manufacturing process [...]

The COVID-19 pandemic has impacted the way the biopharmaceutical industry deals with the already challenging task of manufacturing biologics, which are complex in nature. 'Biologics necessitate more focus on contamination [...]

In government-regulated industries--which include, not only bio/pharmaceutical operations, but aeronautics, automotive, and nuclear power--root-cause analysis (RCA) is integral to effective risk management and mandated by Federal laws. When regulatory failures [...]

The supply of safe and effective medicines is crucial for the patients that rely on them. Drug shortages are an ongoing problem that regulators and industry work to address on [...]

As biopharma manufacturers incorporate more data-driven monitoring and control systems in production processes, the quality of the data, as well as integrating, interpreting, and protecting it, become more important. One [...]

The safety and efficacy of pharmaceutical products is of utmost importance. Regulations in the United States require that pharmaceutical companies establish a quality control unit to perform quality functions to [...]

The safety and efficacy of pharmaceutical products is of utmost importance. Regulations in the United States require that pharmaceutical companies establish a quality control unit to perform quality functions to [...]

Pharmaceutical and biopharmaceutical companies have been extensively using contract research orgzations (CROs) to meet their challenging needs in R&D and standard ork for several decades. A noticeable shift occurred in [...]

The philosopher George Santayana once wrote, 'Those who fail to learn from the past are condemned to repeat it.' This is clearly seen in the way that some pharmaceutical manufacturers [...]

Despite the pandemic, FDA has worked to maintain appropriate oversight of biopharmaceutical production activities, while also advancing strategies to encourage industry adoption of advanced manufacturing systems. The larger goals of [...]

Q. I work for a small start-up company and have been tasked with writing the quality manual for my company. I have searched but have been unable to find regulations [...]

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, answers some commonly asked questions about the difference between the roles of quality assurance and quality control. Q. Theoretically, what's the [...]

Because federal investigators cannot inspect every drug test site or production facility, FDA relies on manufacturers to submit complete and accurate information in all submissions and market applications, especially for [...]

The study on quality assurance (QA) stems from a related project we conducted for a client in 2008/2009 on QA organization in pharmaceutical companies, which raised questions regarding QA. The [...]

Life-sciences companies face more pressure than ever to reduce costs and increase efficiency. The pressures are many and relentless: price constraints, global competition, product complexity, and more challenging therapeutic areas. [...]

Q. I am familiar with the term ALCOA as it relates to data integrity, but lately, I have heard people refer to ALCOA+. Can you explain what impact this new [...]

The benefits of outsourcing manufacturing are well known within the biopharmaceutical industry. Small companies can benefit greatly from working with a CMO by minimizing capital outlays, shortening lead times for [...]