Good manufacturing practice

INTRODUCTION: The objective of the study was to assess if improvement of the learner experience could be achieved through the use of instructional design strategies in current Good Manufacturing Practices (cGMP) training. This is a novel application in a topic that is known to be boring but is critical to ensuring patient safety. METHODS: An experimental randomized controlled repeated measures cross-over design was utilized in a sample of pharmacy students to determine the effect of an intervention training strategy (which utilized a mix of strategies including weeding, signaling, use of multimedia, and optimized space and type) on the learner experience (Evaluation, Overall Satisfaction, Perceived Knowledge, and Future Recommendation) compared with a control...

Magnetic refrigeration technology can achieve higher energy efficiency based on the magnetocaloric effect. However, the practical application of MCE materials is hindered by their poor mechanical properties, making them challenging to process into devices. Conventional strengthening strategies usually lead to a trade-off with refrigeration capacity reduction. Here, a novel design is presented to overcome this dilemma by forming dual-phase alloys through in-situ precipitation of a tough magnetic refrigeration phase within an intermetallic compound with excellent MCE...

BACKGROUND: Urbanization influences food culture, particularly in low- and middle-income countries where there is an increasing consumption of processed and pre-packaged foods. This shift is contributing to a rise in non-communicable diseases. Food labelling standards are crucial for regulating manufacturing practices and helping consumers make healthy food choices. We aimed to assess the compliance of local and imported pre-packaged snacks with Tanzanian and international labelling standards in Dar es Salaam, Tanzania...

BACKGROUND: 3D printing has been used in different medical contexts, although it is underutilised in paediatrics. We present the first use of 3D printing in the management of three paediatric patients with complex renovascular disease. METHODS: Patient-specific 3D models were produced from conventional 2D imaging and manufactured using 3D polyjet printing technology. All three patients had different underlying pathologies, but all underwent multiple endovascular interventions (renal artery balloon angioplasty) prior to 3D printing and subsequent vascular surgery...

Personalized traditional Chinese medicine(TCM) preparations have entered a stage of rapid development. The key to the healthy development of this industry is to establish a sound manufacturing standard and quality control system. This paper analyzed the characteristics of personalized TCM preparations and drew reference from the quality management standards in the production of commissioned decoctions and oral pastes, on the basis of which the production quality management scheme and cautions for the safe production of personalized TCM preparations was put forward with consideration to various problems that may exist and occur in the production of such preparations...

BACKGROUND: The alpha emitter astatine-211 (211 At) is garnering attention as a novel targeted alpha therapy for patients with refractory thyroid cancer resistant to conventional therapy using beta emitter radioiodine (131 I). Herein, we aimed to establish a robust method for the manufacturing and quality control of [211 At]NaAt solution for intravenous administration under the good manufacturing practice guidelines for investigational products to conduct an investigator-initiated clinical trial...

INTRODUCTION: Oral chemotherapies pediatrics are manufactured from injectable specialties in a controlled-atmosphere area. Packaged in Luer-Lock syringes, the transition to an ENFit™ connector became crucial to enable administration in surveyed patients. In parallel, a study was carried out to optimize and secure patient care by setting up a retrocession circuit. OBJECTIVE: To introduce the ENFit™ range of devices into the manufacturing process for oral or enteral chemotherapy syringes...

In accordance with the Circular Economy Package of the European directive, the Spanish government compels manufacturers of plastic bags to include into their products a minimum of 70% of polyethylene (PE) waste. Following this mandate can be challenging and requires a deep knowledge of the alterations produced by the recycling in the main components of a plastic bag film: lineal low-density polyethylene (LLDPE), the LLDPE recycled post-industry, generated as waste from an industrial process (rLLDPE) and the PE recycled from post-consumer use (rPE), that has been picked up, cleaned, and reprocessed...

The medical electron linear accelerator（LINAC） has the characteristics of complex system structure, many core components and high precision control requirements, which puts forward higher requirements for product quality control and regulation. This study puts forward the main points of field inspection through the analysis of the technical characteristics and production risk of LINAC, combined with the requirements of the good manufacturing practice of medical devices. It has certain reference significance for quality management personnel and field inspectors...

OBJECTIVES: This clinical study aimed to assess the trueness of three intraoral scanners for the recor-ding of the maximal intercuspal position (MIP) to provide a reference for clinical practice. METHODS: Ten participants with good occlusal relationship and healthy temporomandibular joint were recruited. For the control group, facebow transferring procedures were performed, and bite registrations at the MIP were used to transfer maxillary and mandibular casts to a mechanical articulator, which were then scanned with a laboratory scanner to obtain digital cast data...

UNLABELLED: To avoid unexpected failures of units in manufacturing systems, failure mode recognition and prognostics are critically important in prognostics health management (PHM). Most existing methods either ignored the effects of various failure modes on remaining useful lifetime (RUL) prediction or implemented failure mode recognition and RUL prediction as two independent tasks, which failed to exploit failure mode information to obtain accurate RUL prediction. In fact, RUL highly depends on failure modes because sensor signals under different failure modes usually present different degradation patterns...

PURPOSE: CD137 is a T- and NK-cell costimulatory receptor involved in consolidating immunologic responses. The potent CD137 agonist urelumab has shown clinical promise as a cancer immunotherapeutic but development has been hampered by on-target off-tumor toxicities. A CD137 agonist targeted to the prostate-specific membrane antigen (PSMA), frequently and highly expressed on castration-resistant metastatic prostate cancer (mCRPC) tumor cells, could bring effective immunotherapy to this immunologically challenging to address disease...

Near-infrared (NIR) spectral information is important for detecting and analyzing material compositions. However, snapshot NIR spectral imaging systems still pose significant challenges owing to the lack of high-performance NIR filters and bulky setups, preventing effective encoding and integration with mobile devices. In this study, we introduce a snapshot spectral imaging system that employs a compact NIR metasurface featuring 25 distinct C4 symmetry structures. Benefitting from the sufficient spectral variety and low correlation coefficient among these structures, center-wavelength accuracy of 0...

INTRODUCTION: Before being implemented in daily clinical routine, new production strategies for platelet concentrates (PCs) must be validated for their efficacy. Besides in vitro testing, the establishment of new methods requires the labeling of platelets for in vivo studies of platelets' survival and recovery. Indocyanine green (ICG) is a Food and Drug Administration-approved near-infrared (NIR) fluorescent dye for diagnostic use in vivo, suitable for non-radioactive direct cell labeling of platelets...

Composite polymer solid electrolytes (CPEs), possessing good rigid-flexible, are expected to be used in solid-state lithium metal batteries. The integration of fillers into polymer matrices emerges as a dominant strategy to improve Li+ transport and form a Li+ -conducting electrode-electrolyte interface. However, challenges arise as traditional fillers: (1) inorganic fillers, characterized by high interfacial energy, induce agglomeration; (2) organic fillers, with elevated crystallinity, impede intrinsic ionic conductivity, both severely hindering Li+ migration...

OBJECTIVE: To describe the process of implementing a traceability and safe drug manufacturing system in the clean room of a Pharmacy Service to increase patient safety, in accordance with current legislation. METHODS: The process was carried out between September 2021 and July 2022. The software program integrated all the recommended stages of the manufacturing process outlined in the "Good Practices Guide for Medication Preparation in Pharmacy Services" (GBPP)...

The translational stem cell research field has progressed immensely in the past decade. Development and refinement of differentiation protocols now allows the generation of a range of cell types, such as pancreatic β-cells and dopaminergic neurons, from human pluripotent stem cells (hPSCs) in an efficient and good manufacturing practice-compliant fashion. This has led to the initiation of several clinical trials using hPSC-derived cells to replace lost or dysfunctional cells, demonstrating evidence of both safety and efficacy...

BACKGROUND AND PURPOSE: Scientific research is crucial to develop therapies for various disease severity levels, as modern drugs cause side effects and are difficult to predict. Researchers are exploring herbal alternatives with fewer side effects, particularly propolis, which has been validated through in vitro, in vivo, and clinical studies. This will focus on scientific evidence and its supporting technology for developing new bioactive compounds for chronic diseases. Nanotechnology can improve the delivery and absorption of herbal medicines, which often have poor bioavailability due to their high molecular weight and solubility in water, particularly in oral medicines...

BACKGROUND: Selective androgen receptor modulators (SARMs) are small synthetic drug molecules that are still not approved as medicine in Europe or the United States but are sold on illegal websites to improve sport performance, particularly bodybuilding. AIM: To address the quality issues of illegal SARM products and their increasing diffusion in Italy with their potential health risks for consumers. METHODS: Web-based tools were used to investigate retail websites, trending searches, and information exchange via social media...

OBJECTIVE: A Phase II trial was conducted to determine if nasal disinfection with a commercial Good Manufacturing Practice-manufactured 0.5% povidone-iodine nasal spray (Nasodine®) may be a useful adjunct in the management of COVID-19 by reducing viral shedding and prevention of transmission of SARS-CoV-2. The aim was to confirm the results from a human single-dose pilot study by assessing repeated and frequent doses on nasal shedding of SARS-CoV-2 from adult subjects with confirmed COVID-19...