pharmaceutical quality Articles
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It is possible for pharmaceutical quality to be the combination of Quality by Design (QbD) and current Good Manufacturing Practices (cGMP)?
The following is the summary of a noteworthy discussion from the 2019 GMP Academy Master Course – Particle Measuring Systems, Rome, Italy The first GMP Academy Master Course took place from November 26 – 28 at Particle Measuring Systems (PMS) in Italy. International experts met to share their knowledge and expertise of regulatory requirements and practical applications pertaining to ...
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Catching Up with GMP Requirements
This two-part blog series discusses current good manufacturing practices (GMPs) and how they can be applied to a continuous environmental monitoring system installed within a pharmaceutical manufacturing facility. Quality and Production teams can then establish new environmental monitoring understandings and harmonize with ...
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Maintaining Quality in Stem Cell Products: ATMPs and Regulation (Series Part 2 of 4)
What are ATMPs? Stem cells are categorized as Advanced Therapy Medicinal Products (ATMPs) when undergoing substantial manipulation or when used for a different essential function. ATMPs are medicines for human use with gene, tissue or cell components. They can be classified into gene therapy medicines, somatic-cell therapy medicines, and tissue-engineered medicines, depending on how the medicine ...
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When It Comes to Screening Media, Quality Matters
In precise industrial processes, all equipment and constituent parts must work together to drive performance and efficiency. For screening and sifting materials in the pharmaceutical, chemical, aggregate and other industries, your choice of media goes a long way toward determining the effectiveness of your machines. Even the best vibratory sifters are only as efficient as the screens they use to ...
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Endocrine disruption due to estrogens derived from humans predicted to be low in the majority of U.S. surface waters
In an effort to assess the combined risk estrone (E1), 17β‐estradiol (E2), 17α‐ethinyl estradiol (EE2), and estriol (E3) pose to aquatic wildlife across United States watersheds, two sets of predicted‐no‐effect concentrations (PNECs) for significant reproductive effects in fish were compared to predicted environmental concentrations (PECs). One set of PNECs was developed for evaluation of effects ...
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Changing tides: Adaptive monitoring, assessment and management of pharmaceutical hazards in the environment through time
Pharmaceuticals are ubiquitous contaminants in aquatic ecosystems. Adaptive monitoring, assessment and management programs will be required to reduce the environmental hazards of pharmaceuticals of concern. Potentially underappreciated factors that drive the environmental dose of pharmaceuticals include regulatory approvals, marketing campaigns, pharmaceutical subsidies and re‐imbursement ...
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A Brief Look Through the Packaging and Labelling Guidelines for Pharmaceuticals
Adhering to quality standards implies much more than maintaining the consistency of the product quality especially for the pharmaceutical manufacturers. They should consider other aspects as well including the packaging and labeling guidelines that the FDA has released to ensure that all the medical supplies reach safely to the patients. The quality management system for pharmaceutical ...
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Stability Analysis: A Meaningful, Impactful and At-the-Forefront Tool for Pharmaceutical Science
In the field of pharmaceutical science, stability analysis plays a crucial role in ensuring the safety and efficacy of pharmaceutical products. It is a complex and multifaceted process that requires thorough investigation and understanding of various influencing factors. Stability analysis consists of different methods such as influencing factors analysis, long-term accelerated shelf-life ...
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The Effects of Excipients on Pharmaceutical Preparation
Excipients are very important for pharmaceutical preparations. It can be said that without excipients, there will be no pharmaceutical preparations, let alone different pharmaceutical dosage forms such as powders, granules, tablets, oral liquids or injections. When the drug and the appropriate excipients are combined into a specific dosage form, the drug would become safer, more stable and more ...
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The Effects of Excipients on Pharmaceutical Preparations in Drug Design
Excipients are very important for pharmaceutical preparations. It can be said that without excipients, there will be no pharmaceutical preparations, let alone different pharmaceutical dosage forms such as powders, granules, tablets, oral liquids or injections. When the drug and the appropriate excipients are combined into a specific dosage form, the drug would become safer, more stable and more ...
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10 Challenges that Pharmaceuticals face for Equipment Maintenance
Pharmaceutical is among the industries that have complex processes. It continuously requires new strategies to improve the ongoing operations, achieve business goals, and maintain competitiveness. One of the common mistakes they make while developing business strategies is not considering equipment maintenance. That’s why pharmaceutical companies face numerous challenges for their ...
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Understanding API-Excipient Interactions in Pharmaceutical Formulations
Pharmaceutical formulations consist of active pharmaceutical ingredients (APIs) and excipients. Appropriate excipient selection is critical to the final quality of pharmaceutical products. When designing pharmaceutical preparations, the choice of excipients should not only consider the dosage form factors and excipient functions but also the interaction and compatibility between APIs and ...
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Regulatory Landscape Continues To Influence Product Recalls
Product recalls may be the least welcome part of the quality landscape, but companies that don’t put the right strategies in place to prevent these events happening are likely to keep repeating the same compliance and poor quality mistakes. The latest quarterly report from recall solutions and quality audit provider Stericycle bears out the common wisdom that recall-related headlines about ...
By EtQ, LLC
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Top 5 benefits of wastewater treatment for pharmaceutical industries
Waste waters are generated as the outcomes of various processes like chemical synthesis, fermentation, etc in a pharmaceutical industry. Hence, wastewater treatment has become mandatory for these industries to maintain the optimum quality. Moreover, such treatments are inevitable for the companies to meet the desired legal standards in pharmaceutical production. Violating such requirements can ...
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Temperature Excursion Management in Pharmaceutical Storage
The quality of pharmaceuticals relies on the environment controls during its storage and handling. Every pharmaceutical item ought to be taken care of and stored under manufacturer-recommended storage condition marked on data information sheet or packaging. Temperature Excursion Management in Pharmaceutical Storage is important during receipt of raw materials, manufacturing and distribution of ...
By AKCP
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A New Challenge for Quality Experts - the Data Quality Concept
Abstract The role of quality systems in pharmaceutical organizations has grown faster than any other function during the last 15 years. During this period, a small group dedicated to traditional Compliance grew and expanded to include Quality Experts in areas such as validation, product release, operations, sterility assurance, and other specialized functions. Creating a deeper quality connection ...
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Microbial Survival in Compressed Gases Under Fast Decompression to Normal Atmospheric Conditions
Introduction and Goal Compressed gases are broadly used in medicinal production facilities. A variety of different gases can be introduced into the process at various stages of a product’s manufacture for different reasons. Compressed gases such as air, nitrogen, and carbon dioxide are regularly used in cleanrooms and are frequently employed in purging or overlaying. The cleanliness of ...
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Pharmaceutical / Personal care product manufacturer promotes quality standards
Challenge Pharmaceuticol manufacturers demand high qualify water with the fewest dissolved solids possible, to promote product consistency. A Canadian manufacturer of pharmaceutical/personal core products was looking to maintain water quality specifications to promote product consistency and improve product shelf life. First the source water for the manufacturing plont comes from a municipal ...
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Pharmaceutical Sludge - Case Study
Overview of pharmaceutical sludge: Pharmaceutical wastewater is a type of organic wastewater with complex components, high biological toxicity, and difficult-to-degrade substances. It is a recognized source of serious environmental pollution. Pharmaceutical wastewater is discharged intermittently, and the water quality and volume fluctuate greatly. Pharmaceutical sludge refers to the ...
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The Benefits of Partnering with a Contract Manufacturing Organization (CMO) for Generic Pharmaceutical Companies
The generic pharmaceutical industry is fiercely competitive, with each company striving to add new products and expand its portfolio. However, not all companies possess the necessary resources to undertake such endeavours. Some lack the requisite experience in commercial-scale production using the latest technology, while others lack the capacity to ramp up manufacturing. ...
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