Pharmaceutical Quality Assurance Research Articles

Total combined risk of false conformity decisions in pharmaceutical equivalence of acetaminophen oral solution

Pharmaceutical equivalence studies are fundamental to ensure the interchangeability, quality, efficacy, and safety of generic and similar medications. This work addresses the crucial aspect of estimating the total combined risk of false conformity decisions in such studies, focusing on acetaminophen oral solutions. Traditionally, these studies rely on pairwise comparisons, but this work introduces a multiple comparison evaluation (for 3 or more medicines). Based on measurement uncertainty evaluations and Monte Carlo simulations, the study reveals varying risk levels among different acetaminophen products. Products (A and E), with pH test results near or exceeding specification limits, exhibit higher risks. Furthermore, the impact of correlations between measured parameters within a single product on total combined risk values was considered. The assessment of risk considering multiple comparisons was affected by the number of medications considered (simultaneous comparisons between 3, 4, or 5 medicines). This study highlights the critical role of rigorous analytical assessment and underscores the need to consider the measurement uncertainty data and correlations between measured parameters in decision-making in pharmaceutical quality assurance.

A SYSTEMATIC REVIEW: EXPLORATION OF PROCESS ANALYTICAL TECHNOLOGY TECHNIQUES (PAT) AND THEIR MULTIFACETED ADVANTAGES IN INDUSTRIAL PROCESSES

FDA initiated the PAT technology framework in the year of 2004 with the guidelines of “A framework of innovative pharmaceutical development, manufacturing and quality assurance. With that, the International Council for Harmonisation has also initiated continuous process verification to overcome the limitations of traditional methods and improve the understanding of the process and quality of the product throughout the product lifecycle. Since the year of implementation, the advancement of analytical and chemometric tools has evolved to deliver consistent quality products by understanding their process and product performance. However, the pharmaceutical industry was lacking in this technicality and implementation of highly regulated specifications. To this respect, we have stated some of the PAT tools, including NIR, Raman and Terahertz spectroscopy, as they will transfer to the futuristic prospects of analyzing the drug product with non-destructive, improved process understanding, real-time monitoring, and enhanced data integrity. This review article emphasizes the importance of PAT technology with different monitoring processes with their historical background and regulatory framework. Special attention was given to strategies, challenges, opportunities, and the compatibility of PAT tools with data fusion. Further, this will give a high-priority disciplinary scientific topic to Pharma 4.0.

Faith-based Pharmaceutical Supply Chains and their Role in African Pharmaceutical Systems: A Qualitative Systematic Review

For the health system to function well, the population must have equitable access to quality, affordable pharmaceutical supplies; however, pharmaceutical systems in Africa are challenged by inadequate funding, drug stock outs and irregular supplies, a shortage of trained pharmacy personnel, and a lack of systems for drug regulation and quality. Faith-based health providers, as private, not-for-profit actors, have long complemented public sector efforts in the supply of pharmaceuticals in Africa. However, the contribution of faith-based health providers in pharmaceutical systems has not been formally studied. This study examines the nature and function of faith-based healthcare providers in improving access to pharmaceutical supplies in Africa. To do so, we conducted an exploratory qualitative systematic review to identify documents that contain information on faith-based involvement in pharmaceutical supply in Africa. The review identified 20 articles for inclusion. These articles were analyzed using thematic, narrative analysis. The analysis revealed a significant evidence gap relating to the contribution of private-not-for-profit, faith-based providers to African pharmaceutical systems. The review suggests that while faith-based drug supply organizations have existed for a long time and contribute significantly to national pharmaceutical systems, there is very little known about the nature of faith-based pharmaceutical providers and how they complement public sector pharmaceutical systems. In many contexts, faith-based involvement in pharmaceutical systems improved access for the general population and increased the supply of pharmaceuticals in national systems. Faith-based drug supply organizations also often provide pharmaceutical supplies to both rural and urban areas, often targeting rural and remote areas particularly. The review also indicates that faith-based drug supply organizations improved access to medicines and related commodities and, despite a lack of regulation in many contexts, have the potential to make a positive contribution to quality assurance of pharmaceuticals. In summary, the analysis confirmed that faith-based involvement in pharmaceutical supply chains contributes to strengthening the national health system by complementing the public pharmaceutical system through improved access to medicines and related commodities in Africa. These conclusions corroborate the need to continually document and acknowledge faith-based healthcare providers efforts which could guide the formulation of stringent, evidence-based strategies.

Quantitative analysis of drug tablet aging by fast hyper-spectral stimulated Raman scattering microscopy.

Pharmaceutical development of solid-state formulations requires testing active pharmaceutical ingredients (API) and excipients for uniformity and stability. Solid-state properties such as component distribution and grain size are crucial factors that influence the dissolution profile, which greatly affect drug efficacy and toxicity, and can only be analyzed spatially by chemical imaging (CI) techniques. Current CI techniques such as near infrared microscopy and confocal Raman spectroscopy are capable of high chemical and spatial resolution but cannot achieve the measurement speeds necessary for integration into the pharmaceutical production and quality assurance processes. To fill this gap, we demonstrate fast chemical imaging by epi-detected sparse spectral sampling stimulated Raman scattering to quantify API and excipient degradation and distribution.

Comparative Analysis of Sibutramine Concentration Determination

This paper underscores the practical implications of employing FTIR RMSE analysis in pharmaceutical research. It highlights the method's rapid and non-destructive nature for quantifying drug concentration in complex formulations, emphasizing its significance in pharmaceutical quality assurance. The study advocates for integrating FTIR RMSE with conventional gravimetric and volumetric methods to enhance the analytical toolkit for pharmaceutical compound analysis. Furthermore, it elucidates the potential of FTIR RMSE in expediting analytical processes and improving estimation accuracy. The paper accentuates the synergy between classical gravimetric techniques and modern spectroscopic methods, providing valuable insights into pharmaceutical compound analysis within heterogeneous formulations. In terms of contributions, this paper advances analytical methods in pharmaceutical research by comprehensively exploring traditional gravimetric/volumetric techniques alongside Fourier Transform Infrared Spectroscopy (FTIR) coupled with Root Mean Square Error (RMSE) analysis. It assesses their effectiveness in determining drug concentrations, mainly focusing on sibutramine quantification, a complex active pharmaceutical ingredient. The results indicate a strong correlation (R² = 0.987) between the two methodologies, with FTIR RMSE consistently yielding slightly higher results due to its sensitivity to molecular structural fluctuations and component interactions. In conclusion, this study advocates for integrating FTIR RMSE into pharmaceutical research practices. It emphasizes the need for calibration and refinement of this technique to further enhance estimation accuracy and analytical precision. It underscores the pivotal role of advanced analytical methods in various applications, including pharmaceutical and biomedical fields.

The response to substandard and falsified medical products in francophone sub-Saharan African countries: weaknesses and opportunities

Assuring the quality of medical products manufactured, imported or distributed in francophone sub-Saharan Africa remains a challenge, despite positive signals like the growing engagement in the benchmarking of regulatory authorities and -particularly- in the establishment of the African Medicines Agency. In this short report, we describe the existing activities to prevent, detect and respond to substandard and falsified products (SF) in this region, either through African multilateral organizations and initiatives led by the World Health Organization, or through the contribution of other stakeholders, such as local universities and procurement agencies. We underline that these emerging local stakeholders may play a pivotal role to guide and inform the national regulatory authorities about the prevalence and patterns of SF medical products, complementing the market surveillance and control, and building awareness of the importance of pharmaceutical quality assurance for public health.

Quality by Design Approach: Progress in Pharmaceutical method Development and Validation

Pharmaceutical analysis plays a significant role in pharmaceutical formulation quality assurance and control. Due to the pharmaceutical industries' rapid expansion and the production of pharmaceuticals all over the world, there is a greater need for novel analytical procedures in this sector. Establishing the identification, purity, physical properties, and potency of medications as well as the medication's bioavailability and stability is the goal of analytical method development. A few new drug applications were recently given regulatory flexibility by the Food and Drug Administration for an analytical method based on quality by design. With Quality by design, product design and development are performed methodically. Analytical methodologies have similar opportunities for implementing Quality by design as production procedures do. It consequently enhances formulation design, development efficiency, and capacity. The underpinnings of the QbD approach have been explored in this article due to their use in the creation and validation of analytical procedures. Additionally, a summary of experimental studies reporting the application of the QbD methodology to method development is included.

A QbD Based RP-HPLC Method for Stability Indicating Impurity Profiling of Pyridoxine: Method Development, Validation, and Application

Pyridoxine impurity profiling in bulk and formulations was devised and validated using a reversed-phase high-performance liquid chromatography (RP-HPLC) strategy. The technique was fine-tuned using an Analytical quality by design (QbD) approach, ensuring its dependability and sturdiness. Linearity, accuracy, and precision were carefully examined as key performance indicators. With a relative standard deviation (RSD) < 2%, the approach showed exceptional precision, excellent recovery rates (100 and, 101.2%), and a strong correlation value (R2 = 0.9990). The technique has been used successfully for impurity profiling, and because it indicates stability, it can be used for long-term stability studies. The work contributes to the body of knowledge and has applications for pharmaceutical quality assurance.

Unmasking the purity: reviewingsources and detection methods of organic volatile impurities

Organic Volatile Impurities (OVIs) are residual solvents present in pharmaceutical products as a byproduct of the manufacturing process. These solvents, used in the creation of pharmacological compounds and excipients, often remain in trace amounts in the final medicinal formulations. Their presence is not only a matter of product purity but also of safety, as OVIs can pose significant health risks and environmental hazards. This paper delves into the classification of these residual solvents based on their toxicity levels, offering insights into which solvents are most hazardous and thus require stringent control. It emphasizes the importance of meticulously analyzing these impurities as a critical aspect of quality control in drug production. Additionally, the discussion extends to the methods typically employed for evaluating OVIs, highlighting the limitations of standard production techniques in completely removing these solvents. This leads to a consideration of strategies for minimizing the use of organic solvents in pharmaceutical manufacturing, an essential step towards safer and more sustainable practices. The paper concludes with a look at future trends in detecting and managing OVIs, indicating ongoing developments in this important area of pharmaceutical research and quality assurance.

A Thorough Examination of the Recent Advances in Mass Spectrometry

Abstract: Mass spectrometry has become an essential tool in pharmaceutical analysis, revolutionizing drug development, quality assurance, and our understanding of complex biological systems. This review provides a comprehensive overview of recent advances in mass spectrometry for pharmaceutical analysis. We discuss the fundamentals of mass spectrometry, including ionization and mass analysis principles, as well as the various types of mass spectrometers used in pharmaceutical analysis. We explore high-resolution mass spectrometry (HRMS), tandem mass spectrometry (MS/MS), ambient ionization mass spectrometry, and mass spectrometry imaging (MSI), highlighting their applications in drug characterization, quantification, imaging, and biomarker discovery. Furthermore, we examine the challenges faced by mass spectrometry, such as matrix effects and data interpretation, and discuss emerging trends and future perspectives. By understanding the recent advancements and addressing the challenges, mass spectrometry can continue to drive advancements in pharmaceutical analysis and quality assurance

The Importance of Good Manufacturing Practices (GMP) in the Healthcare Industry

In the healthcare industry, maintaining high-quality standards is crucial to ensure the safety and efficacy of medical products. Good Manufacturing Practices (GMP) provide a set of guidelines and regulations that help ensure the consistent production, control, and quality assurance of pharmaceuticals, medical devices, and other healthcare products. This paper explores the significance of GMP in the healthcare industry, highlighting its background, objectives, role in safeguarding patient health and maintaining public trust. It examines the key principles of GMP, its regulatory framework, and its impact on various aspects of the healthcare sector, including drug manufacturing, quality control, product safety, and regulatory compliance. Furthermore, the paper discusses the challenges and future perspectives of GMP implementation, emphasizing the need for ongoing advancements to meet the evolving demands of the industry. To summarize, adherence to GMP standards is crucial for the healthcare industry to produce high-quality, safe, and effective healthcare products. GMP compliance promotes patient safety, regulatory compliance, and innovation in the pharmaceutical industry.

Investigation of Physico-Chemical Stability and Aerodynamic Properties of Novel "Nano-in-Micro" Structured Dry Powder Inhaler System.

Pulmonary drug transport has numerous benefits. Large surface areas for absorption and limited drug degradation of the gastrointestinal system are provided through the respiratory tract. The administration is painless and easy for the patient. Due to their better stability when compared to liquid formulations, powders have gained popularity among pulmonary formulations. In the pharmaceutical sector, quality assurance and product stability have drawn a lot of attention. Due to this, it was decided to perform a long-term stability study on a previously developed, nanosized dry powder inhaler (DPI) formulation that contained meloxicam. Wet milling was implemented to reduce the particle size, and nano spray-drying was used to produce the extra-fine inhalable particles. The particle diameter was determined using dynamic light scattering and laser diffraction. Scanning electron microscopy was utilized to describe the morphology. X-ray powder diffraction and differential scanning calorimetry were applied to determine the crystallinity. In an artificial lung medium, the in vitro dissolution was studied. The Andersen Cascade Impactor was used to investigate the in vitro aerodynamic characteristics. The stability test results demonstrated that the DPI formulation maintained its essential qualities after 6 and 12 months of storage. Consequently, the product might be promising for further studies and development.

Molecules that Generate Fingerprints: A New Class of Fluorescent Sensors for Chemical Biology, Medical Diagnosis, and Cryptography.

ConspectusFluorescent molecular sensors, often referred to as "turn-on" or "turn-off" fluorescent probes, are synthetic agents that change their fluorescence signal in response to analyte binding. Although these sensors have become powerful analytical tools in a wide range of research fields, they are generally limited to detecting only one or a few analytes. Pattern-generating fluorescent probes, which can generate unique identification (ID) fingerprints for different analytes, have recently emerged as a new class of luminescent sensors that can address this limitation. A unique characteristic of these probes, termed ID-probes, is that they integrate the qualities of conventional small-molecule-based fluorescent sensors and cross-reactive sensor arrays (often referred to as chemical, optical, or electronic noses/tongues). On the one hand, ID-probes can discriminate between various analytes and their combinations, akin to array-based analytical devices. On the other hand, their minute size enables them to analyze small-volume samples, track dynamic changes in a single solution, and operate in the microscopic world, which the macroscopic arrays cannot access.Here, we describe the principles underlying the ID-probe technology, as well as provide an overview of different ID-probes that have been developed to date and the ways they can be applied to a wide range of research fields. We describe, for example, ID-probes that can identify combinations of protein biomarkers in biofluids and in living cells, screen for several protein inhibitors simultaneously, analyze the content of Aβ aggregates, as well as ensure the quality of small-molecule and biological drugs. These examples highlight the relevance of this technology to medical diagnosis, bioassay development, cell and chemical biology, and pharmaceutical quality assurance, among others. ID-probes that can authorize users and protect secret data are also presented and the mechanisms that enable them to hide (steganography), encrypt (cryptography), and prevent access to (password protection) information are discussed.The versatility of this technology is further demonstrated by describing two types of probes: unimolecular ID-probes and self-assembled ID-probes. Probes from the first type can operate inside living cells, be recycled, and their initial patterns can be more easily obtained in a reproducible manner. The second type of probes can be readily modified and optimized, allowing one to prepare various different probes from a much wider range of fluorescent reporters and supramolecular recognition elements. Taken together, these developments indicate that the ID-probe sensing methodology is generally applicable, and that such probes can better characterize analyte mixtures or process chemically encoded information than can the conventional fluorescent molecular sensors. We therefore hope that this review will inspire the development of new types of pattern-generating probes, which would extend the fluorescence molecular toolbox currently used in the analytical sciences.

Formulation and Evaluation of Phytosomes of Hydroalcoholic Extract of Adiantum capillus-veneris for Antimicrobial Activity

Pharmacognosy Research,2023,15,3,468-477.DOI:10.5530/pres.15.3.048Published:June 2023Type:Original Article Authors:Supriya Ganesh Jagtap, Vedant Vinay Kajale, Mukta Mahesh Abhyankar, Aditi Shrinivas Kulkarni, and Minal Rushikesh Ghante Author(s) affiliations:Supriya Ganesh Jagtap1,*, Vedant Vinay Kajale2, Mukta Mahesh Abhyankar1, Aditi Shrinivas Kulkarni1, Minal Rushikesh Ghante2 1Department of Pharmacognosy, STES’s, Smt. Kashibai Navale College of Pharmacy, Kondhwa (Bk), Pune, Maharashtra, INDIA. 2Department of Pharmaceutical Quality Assurance, STES’s, Smt. Kashibai Navale College of Pharmacy, Kondhwa (Bk), Pune, Maharashtra, INDIA. Abstract:Background: Natural plant extracts and phytoconstituents have high in vitro bioactivity but low in vivo bioactivity because of poor lipid solubility, multiple ring large molecules, or digestion in the gut. Polyphenolic phytoconstituents were complexed with phospholipids, mainly phosphatidylcholine, which molecularly attaches components to one another to produce novel drug delivery systems like phytosomes. The important constituents of the herbal extract are designed to protect from being disrupted by gastric juices and gut bacteria, as phytosomes have the ability to cross the bio-membranes that which are lipid enriched and boost bioavailability. Objectives: The current work is aimed to formulate and evaluate phytosomes from Adiantum capillus-veneris (ACV) hydroalcoholic extract for antimicrobial activity. Materials and Methods: Antisolvent precipitation method was chosen on the basis of the solubility of hydroalcoholic extract in dichloromethane. The prepared trial batches of the phytosomes complex were characterized by using particle size, zeta potential, drug entrapment efficiency, drug content, and in vitro drug release study. The optimized batch of phytosomes was characterized for compatibility studies by using Infrared Spectrometry (IR), Transmission Electron Microscopy (TSM), Differential Scanning Calorimetry (DSC), and further for stability studies. Results: The results revealed that ACV hydroalcoholic extract and phosphatidylcholine were found to be connected by a non-covalent bond and did not generate a new molecule in the ACV hydroalcoholic extract-phosphatidylcholine complex and showed enhanced in vitro antimicrobial activity as compared to the hydroalcoholic extract. Conclusion: The complex's dissolution profile was found to be improved. As a result, the phospholipid complex of ACV extract can therefore be concluded to have the potential to enhance bioavailability. Keywords:Adiantum capillus-veneris (ACV), Antimicrobial activity., H-ACV extract phytosomes, Hydroalcoholic extract, PhytosomesView:PDF (549.56 KB)

A review on implementation of automation in the pharmaceutical industries

Automation is the use of various control systems in industries with little to no human intervention to carry out a variety of tasks. In recent years, automation has migrated to the pharmaceutical sector. Production, packing, labeling, and warehousing departments have all used automation. The use of automated equipment has made the production of customized medications a reality. Using the newest technologies has also had an impact on the R&D sector. The traditional duties of the QA department were restricted to creating SOPs, conducting audits, qualifying, and validating processes and equipment. The deployment of automated technology in the pharmaceutical sector and its effects on the department responsible for pharmaceutical quality assurance are the main topics of this research. The Raman probe and other subjects are covered in this article. Production, packing, labeling, and warehousing departments have all used automation. After the introduction of automated machinery, the creation of customized medications has come to pass. Thus, these systems might be able to take the place of human inspectors. With this technology, you have more flexibility and repeatability for less money.

A Review on Introduction to Quality Assurance

Quality assurance (QA) is the management technique used to provide adequate confidence that a product, service, or result will satisfy requirements for quality and be fit for use. Each monitoring program or assessment must strive to generate data that is precise, dependable, and sufficient for the specified purpose. Data quality objectives are qualitative and quantitative standards that are used to create a system that will keep the level of uncertainty within permitted boundaries and at an acceptable level. Quality assurance will boost public and funding body confidence. Unconfirmed observations should not be used until they can be verified. Robust pharmaceutical quality assurance system ensures that products are effective and safe. Following good manufacturing practices (GMP) and enacting comprehensive inspection policies help drug manufacturers produce the highest quality products and avoid reputation-damaging incidents. Product Quality Review (PQR) is a mechanism to ensure that data captured by the Pharmaceutical Quality System (PQS) is reviewed for trends. This tool can support a continuous improvement environment. PQRs are designed for the purpose of identifying and implementing recommendations for required improvements. Quality control and quality assurance jobs are all about ensuring the medication has been manufactured correctly and is safe to use, as well as having its desired effect. Without these two functions of quality management, a pharmaceutical organisation would struggle to achieve consistency in its output. Quality assurance (QA) is any systematic process of determining whether a product or service meets specified requirements. QA establishes and maintains set requirements for developing or manufacturing reliable products.

Oral Submucosal Fibrosis: A Potentially Malignant Condition to be Considered

Sukeshini Lote1, Kunal Kotkar2, Maheshwari Nikam2, Yash Dhadiwal2, Sandesh Zade2 and Virashri Patil2 Author informationArticle notesCopyright and License information 1Datta Meghe College of Pharmacy, Datta Meghe Institute of Higher Education and Research (DU), Sawangi (Meghe) Wardha, Maharashtra, INDIA 2Department of Pharmaceutical Quality Assurance, R C Patel Institute of Pharmaceutical Education and Research, Shirpur, Dhule, Maharashtra,

Simultaneous Analysis of Lamivudine and Dolutegravir Sodium in Formulation Using First Order Derivative Method

Sapna M. Rathod, Paresh U. Patel and Nisarg C. Patel Author informationArticle notesCopyright and License information Department of Pharmaceutical Chemistry and Quality Assurance, APMC College of Pharmaceutical Education and Research, Himatnagar, Gujarat, INDIA Department of Pharmaceutical Chemistry and Quality Assurance, S. K. Patel College of Pharmaceutical Education and Research, Ganpat University, Kherva, Gujarat, INDIA Department

Pharmaceutical Quality Assurance of Diazepam Injection at the National Health Laboratory of Mali

Objectives: In a world marked by the increase in chemoresistance leading to the adoption of therapeutic combinations, the advent of generic multi-source drugs, the spread of counterfeiting and substandard drugs, often without active ingredients or falsified active ingredients, a Greater vigilance by pharmaceutical regulatory authorities is needed. Drug Post-Marketing Surveillance (PMS) therefore plays an important role in detecting poor quality products on the market. Methods: The survey covered certain regions and certain points of sale. It aimed to assess the quality of Diazepam injection available on the market. The selection of drugs and geographic areas was made using risk-based sampling using the Drug Risk Assessment Tool (MedRS) developed by USP / PQM +. Results: A total of 44 samples were analyzed according to a risk-based protocol, of which 32 were compliant with a rate of 91% against 12 non-compliant or 9% (P≤0,05). Non-compliant drugs were mainly from the public sector. We also found that all samples were unregistered. Conclusion: The results clearly raise the issue of registration of drugs before their market authorization and the importance of continuous quality control and post-marketing drug analysis to ensure health and guarantee access to quality medicines for the health and well-being of populations.

Pharmaceutical Quality Assurance of Diazepam Injection at the National Health Laboratory of Mali

Pharmaceutical Quality Assurance of Diazepam Injection at the National Health Laboratory of Mali