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The article delves into the evolving landscape of Quality Risk Management (QRM) within the pharmaceutical industry, particularly focusing on the emergence of subjectivity as a critical factor influencing risk assessment and decision-making processes. It highlights the challenges posed by subjectivity, and explores the implications for product quality, patient safety, and drug availability.

The article requests in the form of a section "call for papers," to authors to send in their contribution through articles and topics related to pharmaceutical technology for the journal "Pharmaceutical Technology." The editor emphasizes on the utility, novelty and non-obvious- ness in the contributions. He further clarifies on the aspects related to the journal and the industry. Later he apologizes for the reflexive stroke of the red pen. He agrees that process analytical technology may actually merit the word, "paradigm."

The article focuses on recent trends in consumer-directed innovation in the often called over the-counter (OTC) pharmaceutical market. It mentions that increasing competition in consumer pharmaceuticals and limited resources for developing innovative forms in-house paved the way for partnerships between drug delivery specialists and contract development and manufacturing organizations (CDMO); and the OTC industry has also leveraged technology from outside of oral solid dose manufacturing.

Discusses recommendations made by the Drug Availability Task Force of the Healthcare Distribution Management Association regarding the establishment of collaborative relationships with trading partners to ensure that products are continuously available. Need to create a shared database listing warehouse closing during the year-end holiday season; Need for the pharmaceutical industry to list the process and contacts for emergency orders when warehouses are closed.

This study reviews changes in in-country testing (registration testing, import testing) requirements and analyzes current trends. In the context of international harmonization of good practices and standards as well as the improved information exchange between national regulatory authorities, in-country testing is considered outdated and redundant in many cases. More and more countries acknowledge the limited value of in-country testing compared to the benefit of full or partial testing waivers. Analyzing the changing testing requirements, the authors find that a predominant trend is waiver schemes based on unilateral reliance on reference countries with a mature regulatory system. [ABSTRACT FROM AUTHOR]

The article discusses the growing need for effective data management in the life science industry including smaller pharmaceutical manufacturers. It informs about traditional approach for data management which involves manual collection of data from storage source across supply chain including paper batch records. It suggests companies to adopt process-intelligence-based approaches for data management which reduces risks and deliver better results to investors and healthcare consumers.

Until the period of June 20, 2005, all distributions of Schedules I and II controlled substances required the completion of the U.S. Drug Enforcement Administration's (DEA) Form 222. As of May 31, 2005, DEA came out with an electronic alternative to the paper form. DEA says that the system will go live soon, although it has not released a specific date. In this article, the author focuses on this electronic alternative. More than five years in development, the Controlled Substance Ordering System can be used by pharmacists and other DEA registrants in place of the paper DEA 222 forms. DEA hopes the system will cut down on errors, reduce turnaround time for orders, and allow pharmacists to maintain smaller inventories of these substances.

Examines the issues that are hastening the phase-out of drug dossiers. Insufficiency of drug dossiers for products to obtain market entry; Greater role played by patients in the regulatory process; Shift from national to global requirements; Moving from paper to electronic documents.

The article focuses on the critical role of excipient grade and quality in drug products. Topics include the definition and regulatory requirements for excipients, the importance of traceability and proper supplier qualification in preventing safety issues, and the need for improved communication between excipient suppliers and drug manufacturers to ensure appropriate material use.

Focuses on the progress made by the pharmaceutical industry in the United Kingdom regarding the frontiers of information provided to people about medicines. Main proposals of the government's Freedom of Information white paper; Significance of the white paper to the industry and patients; Principles of Association of the British Pharmaceutical Industry that are relevant to pharmaceutical companies.

The article focuses on insights provided by Steffen Thirstrup, the chief medical officer at the European Medicines Agency, regarding regulatory challenges and successes in Europe's pharmaceutical landscape. Topics discussed include the impact of the COVID-19 pandemic on regulatory agility, challenges and collaborations in drug pricing and reimbursement, and efforts to enhance supply chain resilience and proximity to manufacturing infrastructure.

The article focuses on how pharmaceutical companies utilize patient-savings branded-drug programs and copay assistance incentives to help patients defray their medical costs. The author cites that pharmaceutical companies have experimented with a variety of different platforms and formats through which to deliver the programs. It also identifies that programs and incentives have significant differences in terms of how pharmaceutical companies provide incentives to pharmacists.

The article explores the current biopharmaceutical industry is estimated at more than US$400 billion (€345 billion) per year revenue and continues to grow at a healthy rate. Biopharmaceutical revenue and related aspects, including R&D investments and bioprocessing, are continuing to grow at slightly over 12% annually, essentially doubling approximately every five years, according to BioPlan Associates' Annual Report and Survey of Biopharmaceutical Manufacturing.

The article presents the highlights of the virtual 4th Pharmacy Benefit Management Institute (PBMI) Annual Specialty Rx Forum held on October 16, 2020. Topics include the strategies to maintain patient centeredness amidst the COVID-19 pandemic, the solutions to optimize patient engagement and strategies towards timely medication access, and the lessons learned from the pandemic. Attendees include Alex Jung of EY-Parthenon.

The article delves into the evolving landscape of drug dosage forms, driven by advancements in personalized medicine, AI (artificial intelligence), and emerging modalities. It highlights the impact of patient adherence, permeability, and complex therapeutics on dosage form development, showcasing innovative technologies and strategies to meet evolving patient needs and regulatory requirements.

The article offers information on a study related to the use of Celsius bags in biotechnology industry for freezing protein bulk drug solutions (BDS) using a cryoprocessing unit. It informs that protein BDS can be frozen in various configurations including plastic containers, stainless steel vessels and tanks and plastic bags. It also informs that freezing of protein BDS enables longer shelf-life for drugs.

The article focuses on the new European Union (EU) guidance for drug developers regarding the conduct of paediatric investigation plans (PIPs) issued by the European Medicines Agency (EMA) on February 6, 2023. It informs that the guidance was issued to address shortfall in paediatric regulation and improve harmonization of pedantic regulations.

The article reports that the International consortium on Innovation and Quality in Pharmaceutical Development (IQ Consortium) explores and defines common industry approaches and practices when applying good manufacturing parctices (GMPs) in early development. A consequence of the absence of clarity surrounding early phase GMP guidance has been varied interpretation and application of existing GMP guidance within companies and regulatory bodies according to their own culture and risk tolerance.

A well-designed stress study can provide insight into choosing the appropriate formulation for a proposed product prior to intensive formulation development studies. It can prevent redevelopment or revalidation of a stability indicating analytical method. This paper outlines the scientific aspects of forced degradation studies that should be considered in relation to ANDA submissions. [ABSTRACT FROM AUTHOR]

The article focuses on the development by pharmaceutical manufacturers of smaller, more mobile drug manufacturing processes for point-of-use patient care. Topics covered include the potential of these manufacturing technologies to improve the drug supply chain, the efforts of the U.S. Center of Drug Evaluation and Research's (CDER) aimed at regulating distributed manufacturing, and innovations that might increase the robustness of pharmaceutical manufacturing and reduce local drug shortages.

The article discusses the U.S. Food & Drug Administration (FDA) which revised its process validation guidance, directing that validation must continue throughout the lifetime of a pharmaceutical product. It state that the FDA has advocated three stages such as process design using the principles of pharmaceutical quality by design; the process performance qualification and the continued process verification.

The article explores the shift towards decentralized or distributed manufacturing in biopharmaceutical production, focusing on the potential benefits, challenges, and emerging technologies, with a particular emphasis on point-of-care manufacturing. Topics include the regulatory landscape, advancements in quality assurance/quality control (QA/QC) methods, and the application of advanced manufacturing technologies such as machine learning (ML) and end-to-end continuous manufacturing.

The article focuses on the 10th Annual Report and Survey of Biopharmaceutical Manufacturers in the U.S. of the market biotechnology market research company BioPlan Associates Inc. The reports found two problems in between the Chief marketing officer (CMO) and client including building sufficient time for the project and client's relationship with CMOs.

The article offers information on waiting in queue for good manufacturing practice (GMP) guideline revisions. Topics discussed include guidelines of the European Union on GMP which also include good distribution practice (GDP); views of Koen Laenen, quality manager at medicines for Europe on official meetings with different stakeholders; and uses of new technology on indicating of large proportion of guideline revisions.

The article discusses that the move towards digital processes as the first step to enabling quality management and manufacturing. Topics of discussion includes significant opportunity available for digital technology for improvement in pharmaceutical manufacturing, life-science organizations replacing processes with modern digital applications to meet drug manufacturing demands and challanges to deliver quality products due to business process gaps between quality management systems (QMS).

The article informs that researchers examined the impact of the drug's particle size distribution on its pharmacokinetic parameters following administration intranasally in adult male rats, and discusses the use of nanoparticles for intranasal delivery of a water-insoluble drug.

The article reports that technological developments in real-time supply chain operations provide biologics manufacturers with capabilities that go beyond supply chain visibility to tangibly address security and quality challenges. It mentions improving overall supply chain visibility, enhance security, and assist with the forecasting and planning around problematic scenarios using digital technology.

The fingerprint region in mid-infrared (IR) and Raman spectroscopy, typically between 300 to 1900 cm-1, is used to characterize molecules by utilizing their vibrational and rotational changes in this region. In this study, a smaller subset of this Raman spectral region was evaluated for its significance in characterizing pharmaceutical products. This narrower region from 1550 to 1900 cm-1 in the Raman spectrum will further be defined as the "fingerprint in the fingerprint" region. A spectral evaluation was conducted on active pharmaceutical ingredients (APIs) in prescription drugs, over-the-counter drugs, and pharmaceutical drug products. Qualitative and quantitative analysis was performed on these products to gain an understanding of this spectral region. The qualitative results showed no Raman spectral signals in this region for any of the common excipients. Additionally, all APIs evaluated had unique Raman vibrations and spectral signals in this region. This data indicates that the 1550-1900 cm-1 Raman spectral region is ideal for API identity testing. Furthermore, the data indicate the potential of this spectral region for differentiation and classification of API content in different strengths of a given drug product. [ABSTRACT FROM AUTHOR]

The article offers information on knowledge management in biopharmaceutical companies. It states that the process development of improved technology, novel drugs, increasing research and development investment and laboratory research techniques are shaping up sophisticated research data systems. It mentions that knowledge originates from information, like information originates from data.

The article offers information on unique solutions designed to protect inherently unstable messenger RNA (mRNA) during formulation, manufacturing and shipment. Topics covered include the challenging instability issues of mRNA that must be managed throughout the entire manufacturing process, manufacturing strategies for managing mRNA instability and prevent mRNA degradation, and techniques for minimizing formulation time.

The article focuses on the role of the change and deviation management (CMS) system in the pharmaceutical industry's quality management system. The establishment of the CMS is important in order to examine all the changes that could hamper the control and production of final drug product, active pharmaceutical ingredients (API), or intermediates. The key requirements of CMS include the implementation of automated, electronic, and change management system.

The article focuses on development of biologic drug through integration of quality and careful project management. Topics discussed include impact on performance of process due to poor handling of technology transfer, achievement of high level of supervision and diligence during the transfer of product and availability of standard operating procedures (SOPs) for reflecting process details relevant to the equipment.

The article presents the highlights of a panel of providers of the Prostatic Urethral Lift (PUL) using the UroLift System for the treatment of Benign Prostatic Hyperplasia (BPH). Urologist Claus G. Roehrborn presided over the panel. Steven N. Gange, partner at Summit Urology Group, talked about the role of primary care physicians in the diagnosis of BHP. David Sussman, associate professor at Rowan University in New Jersey, discussed the effect of the low level of consistent patient compliance.

More than ever, drug makers need to be fleet and flexible—and they need their software to be the same. Today's integration approaches do not support the level of responsiveness that firms need to react to the changing regulatory and competitive landscape in which they operate. But by breaking down an application into ‘services’, IT providers may have hit on a way for their software to drive innovation at every point in the value chain. [ABSTRACT FROM AUTHOR]

Reports that a radiotracer technique is a simple, fast and sensitive technique for analyzing the integrity of clinical supply packages to water in drug manufacturing; Determination of water uptake of packaged dosage formulations; Protection of formulation for the duration of clinical trials; Water uptake by tablets.

This article presents information related to the correct selection and use of a desiccant that can prevent many problems occurring and ensures the integrity and performance of finished products in the pharmaceutical industry. Desiccants are materials that adsorb and retain water vapor. Most desiccants are solids that contain a network of interconnected pores that allow water molecules to become attached to the large internal surface. The quality and appearance of some pharmaceutical intermediates, preparations and finished medicines depends substantially on the protection afforded by desiccants.

The article focuses on the renewal of the UK Voluntary Scheme for Branded Medicines Pricing and Access (VPAS) set to end in 2023, detailing the negotiations and changes in the 2024 VPAS, emphasizing the challenges and balance needed for affordability and allowable growth, and discussing the impact on the pharmaceutical industry, patient outcomes, and the NHS.

The article provides insights into the divergent situations of pharmaceutical and biotech companies in 2022 and the first half of 2023, discussing stock market performance and funding challenges. It notes that pharmaceutical companies experienced strong share prices in 2022 but faced challenges in 2023, while the biotech sector saw a significant decline in stock market valuations and a drop in the number of IPOs.

The article presents an interview with Peter Walters, director of advanced therapies at CRB talking about benefits, challenges, and logistics of point-of-use manufacturing. Topics include providing and ensuring the same degree of quality, consistency, and compliance in a point-of-use facility compared to a centralized manufacturer; and encouraging for seeing the industry, regulators, and suppliers coming together for working on processing solutions.

The article discusses the workshop "Best Practices and Applications of Good Manufacturing Practices (GMPs) for Small-Molecule Drugs in Early Development" sponsored by the organization International Consortium on Innovation and Quality in Pharmaceutical Development on February 4-5, 2014 in Washington D.C. The event discussed approaches and practices adopted by the pharmaceutical industry when applying GMPs in early development and justification of impurity specifications for formulations.