Abm Mahfuz Ul Alam

• PhD
• Director at ACI HealthCare Limited, Narayangonj-1440, Bangladesh

Nitrosamine impurities, specifically N-Nitrosodimethylamine (NDMA), N-Nitrosodiethylamine (NDEA), and other related compounds, have emerged as significant contaminants in pharmaceuticals, triggering widespread concern due to their carcinogenic potential. These compounds, classified as probable human carcinogens by the International Agency for Resea...

Highlights • Retrospective review of 192 product recalls from October 2017 to March 2025. • Pharmaceutical drugs accounted for 84.9% of all recall events. • Leading causes included benzene contamination, NDMA impurities, and undeclared active pharmaceutical ingredients (APIs). • Temporal analysis revealed a significant spike in recalls post-2022, c...

Deviation management in the pharmaceutical industry is a core component of a robust Pharmaceutical Quality System (PQS). It ensures compliance with Good Manufacturing Practices (GMP) and demonstrates a company’s commitment to delivering safe, effective, and high-quality medicines to patients. As per the current thinking of global regulators, deviat...

Nitrosamine impurities have become a critical concern in the pharmaceutical industry due to their potent carcinogenicity and widespread occurrence in various drug products. These impurities, typically formed through nitrosation reactions involving secondary or tertiary amines and nitrosating agents, have been detected in several widely used medicat...

Pharmaceutical oral dose technologies are rapidly advancing to meet the ever-evolving demands of modern therapeutics. The selection of appropriate technologies in granulation, blending, compression, coating, and advanced formulations is critical to ensuring the effectiveness, stability, and patient acceptance of oral dosage forms. These technologie...

The article explores the concept that life can be understood as a mathematical system of permutations and combinations, where the variables are our choices, circumstances, and actions. It explains that permutations represent situations where the order of decisions matters, influencing the outcomes—such as the sequence in which we pursue education,...

This research journal investigates the interplay between healthcare expenditure, life expectancy, and demographic characteristics across selected countries from 2000 to 2024. Utilizing quantitative analysis, the study examines healthcare spending as a percentage of GDP, average life expectancy, and the age distribution of populations. For instance,...

In pharmaceutical manufacturing, occupational exposure to potent active pharmaceutical ingredients (APIs) presents a critical health risk, particularly in facilities processing highly potent compounds classified under Occupational Exposure Band (OEB) 4-5. These compounds often have extremely low Occupational Exposure Limits (OELs), requiring robust...

This review provides an in-depth analysis of the Food and Drug Administration's (FDA) guidance document titled ANDA Submissions-Amendments to Abbreviated New Drug Applications (ANDAs) Under the Generic Drug User Fee Amendments (GDUFA), released in September 2024. The document serves as a comprehensive guide for the pharmaceutical industry, detailin...

Nitrosamine impurities have become a significant concern in the pharmaceutical industry due to their carcinogenic potential. In response, the U.S. Food and Drug Administration (FDA) has continuously updated its guidelines to ensure the safety and efficacy of drug products. This review article provides a comprehensive analysis of the evolution of FD...

This describe details of Acids, Bases and Salts including types, reactions and importance.

This study scrutinizes a dataset originating from the FDA’s Form 483 to discern nuanced trends and areas of concern within the realm of regulatory compliance. The dataset encompasses 1983 observations categorized across ten subparts, allowing for a quantitative evaluation of prevalent issues in each section. Subparts J, F, and I emerge prominently,...

This study aimed to determine the bioequivalence of Azithromycin tablets 500 mg manufactured by ACI HealthCare Limited and ZITHROMAX® (azithromycin) tablets 500 mg from Pfizer Labs Division of Pfizer Inc. It was a randomized, double-blind crossover trial conducted at Raptim Research Pvt. Ltd., India, involving healthy adult male subjects in both fa...

The successful development of generic drug products requires meticulous attention to pharmaceutical, bioequivalent, and therapeutic equivalence compared to the reference listed drug (RLD). This entails matching the generic product's active ingredient, dosage form, strength, and route of administration with no significant differences in absorption r...

On May 12, 2023, Iptacopan Hydrochloride Monohydrate received regulatory approval from the US FDA for treating adults with Paroxysmal Nocturnal Hemoglobinuria (PNH). This article provides a comprehensive overview of the drug, including its physicochemical properties, clinical studies, formulation details, specifications, and dissolution studies. Ip...

Title 21 of the Code of Federal Regulations (21 CFR) serves as the cornerstone of regulatory guidance in the United States for industries related to food and drugs. Among its comprehensive sections, 21 CFR Part 211 stands as a pivotal set of regulations governing Current Good Manufacturing Practice (cGMP) for Finished Pharmaceuticals. These regulat...

This article delves into the intricacies of Multiple Unit Pellet System (MUPS) tablet compression, an innovative pharmaceutical formulation technique with significant potential for improving drug delivery systems. The challenges associated with MUPS tablet compression, including achieving uniform pellet size distribution, blend homogeneity, compres...

This study scrutinizes a dataset originating from the FDA's Form 483 to discern nuanced trends and areas of concern within the realm of regulatory compliance. The dataset encompasses 1983 observations categorized across ten subparts, allowing for a quantitative evaluation of prevalent issues in each section. Subparts J, F, and I emerge prominently,...

This study emphasizes the pivotal role of Quality by Design (QbD) in the development of pharmaceutical methods, with a particular focus on risk assessment to ensure consistent quality. The research showcases the creation of a precise and practical HPLC method for Linagliptin Tablets, developed using QbD principles. This optimized method, designed t...

This article explores the transformative integration of Artificial Intelligence (AI) with advanced quality tools in the pharmaceutical industry. From the adoption of Analytical Quality by Design (AQbD) principles in method development to the application of AI in rapid testing, Design of Experiments (DoE), and statistical tools for trending and proc...

This study emphasizes the pivotal role of Quality by Design (QbD) in the development of pharmaceutical methods, with a particular focus on risk assessment to ensure consistent quality. The research showcases the creation of a precise and practical HPLC method for Pregabalin Capsules, developed using QbD principles. This optimized method, designed t...

Abstract: The pharmaceutical industry is responsible for developing and producing pharmaceutical products that are safe, effective, and reliable, thus ensuring public health. Despite advances in technology and stringent regulations, errors in pharmaceutical manufacturing persist, posing risks to patient safety and product quality. Recognizing the...

Chromatographic resolution is a crucial aspect of HPLC analysis, enabling the separation and quantification of analytes in complex samples. In this process, the goal is to achieve well-defined, well-separated peaks to ensure accurate and precise measurements. Several factors play a role in achieving optimal resolution in HPLC. Firstly, the choice b...

Excipients, the inactive components in pharmaceutical formulations, are essential for drug delivery, stability, and overall product performance. However, the quality of excipients, including the presence of contaminants and impurities, can significantly impact human health. This abstract highlights the impact of excipient contaminants and impuritie...

The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) play vital roles in ensuring the quality and safety of pharmaceutical products through Good Manufacturing Practices (GMP) inspections. This paper provides a comparative analysis of the inspection approaches employed by EMA and FDA, highlighting both their similariti...

Design and construction features. Lighting. Ventilation, air filtration, air heating and cooling. Plumbing. Sewage and refuse. Washing and toilet facilities. Sanitation. Maintenance.

History of Atomic Structure Dalton’s Atomic Theory Sub Atomic Particle Rutherford’s Atomic Model Bohr’s Atomic Model Atomic Spectrum Quantum Numbers Pauli’s Exclusion Princ Hund’s Rule of Maximum Multiplicity Aufbau Principle

Understand Regulatory Process Related to GMP Understand GMP elements and learn the current interpretation and best practices Quality & Risk Management System to understand Modern GMP

Summary of GMP Regulatory Process and Regulations of Pharmaceuticals

Understand Regulatory Process Related to GMP Understand GMP elements and learn the current interpretation and best practices Quality & Risk Management System to understand Modern GMP

Training and Qualification of Personnel in Pharmaceuticals

Aquilaria agallocha (Thymelaeaceae) is an important medicinal plant. [1] It is also used for the production of essential oils which is widely used in various pharmaceutical and cosmetic industries . [2] Some of the constituents are also used for food processing and many other purposes. The essential oil was isolated from Aquilaria agallocha by stea...

Method of analysis for determination of CADMIUM, LEAD & NICKEL in magnesium stearate USP was developed in inductively coupled plasma - optical emission spectrometry (ICP-OES). The Methods were found to be highly sensitive, selective, rapid, precise, accurate and affordable which can be followed by pharmaceutical industries. The method in ICP-OES wa...

A simple and precise RP-HPLC Method was developed by QbD approach for Ticagrelor Tablets for routine analysis of pharmaceutical formulations. The method was optimized using design of experiment (DOE) for four factors i.e. buffer pH, % of acetonitrile, flow rate and oven temperature over three responses i.e. retention time, asymmetry and theoretical...

A simple and precise RP-HPLC Method was developed using QbD approach for quantification of Linagliptin Tablets during routine analysis of oral solid dose pharmaceutical tablets of Linagliptin. The method was optimized using design of experiment (DOE) for four factors i.e. buffer pH, % of acetonitrile, flow rate and oven temperature over three res...

DoE analysis of different variables and their respective responses

A simple and precise RP-HPLC Method was developed by QbD approach for Pregabalin Capsules for routine analysis of pharmaceutical formulations. The method was optimized using design of experiment (DOE) for four factors i.e. buffer pH, % of acetonitrile, flow rate and oven temperature over three responses i.e. retention time, asymmetry and theoretica...

A simple and precise HPLC Method was developed by QbD approach for Rabeprazole Tablets for routine analysis of pharmaceutical formulations. The method was optimized using design of experiment (DOE) for four factors i.e. buffer pH, % of acetonitrile, flow rate and oven temperature over three responses i.e. retention time, asymmetry and theoretical p...

Chromatography is the major analytical techniques used in Pharmaceutical Analysis. This presentation provides update so that once can understand what is chromatography, different aspects of chromatography, factors influence performance of analysis (resolution, asymmetry, theoretical plate, retention time, resolution etc.) instrumentation of HPLC in...

Management of Deviation in Pharmaceutical Manufacturing and Quality Operations is one of the important factors for appropriate quality of products. This presentation provide a brief on how to manage deviation in Pharmaceutical Plant.

Risk of cross-contamination is vital in Pharmaceutical manufacturing operations. To have safe and quality product manufacturer should ensure all related risk for cross contamination are assessed and appropriate mitigation strategy are in place. This presentation provide a detail guidance related to this.

Quality by Design (QbD) concept can be applied to analytical method development, because of possibility to evaluate many variables that significantly affect the method performance. These variables are such as instrument settings, sample characteristics, method parameters etc. Especially for a chromatographic separation are the variability due to HP...

Method of analysis for six different non pharmacopeial drugs was developed and the developed method was validated taken care of all criteria of validation process. The Methods were found to be highly sensitive, selective, rapid, precise, accurate and affordable which can be followed by pharmaceutical industries. For estimation of six drugs; Ticagre...

The essential oil was isolated from Aquilaria agallocha (Thymelaeaceae) by steam distillation. Brine Shrimp bioassay result of this oil showed cytotoxic activity (LD50 0.000682 µg/mL after 24 hrs and LD50 0.00029 µg/mL after 48 hrs). The composition of hexane soluble part of this oil was analyzed by GCMS and thirty eight (38) different compounds we...

Four compounds namely, Ethyl (3’-hydroxy, 4’-methoxy, β-phenyl)-β-D-(3-O-α-L-rhamnosyl, 4-feruoyl)-β-D-glucoside (Martynoside), 3,4—dihydroxy cinnamic acid, mixture of stigmasterol and β-sitosterol glycoside and 5,7,4’-trihydroxy flavoone (Crysoeriol) were isolated from Leucas indica whole plant. The structure of these compounds were elucidated by...

Four compounds namely, Ethyl (3’-hydroxy, 4’-methoxy, β-phenyl)-β-D-(3-O-α-L-rhamnosyl, 4-feruoyl)-β-D-glucoside (Martynoside), 3,4—dihydroxy cinnamic acid, mixture of stigmasterol and β-sitosterol glycoside and 5,7,4’-trihydroxy flavoone (Crysoeriol) were isolated from Leucas indica whole plant. The structure of these compounds were elucidated by...

Methanol extracts of Leucas indica was tested for its effect on fasting and postprandial blood-glucose level on normal, NIDDM and IDDM model rates at different prandial states i.e. fasting condition, simultaneously with glucose load and 30 min before glucose load. This bioassay results indicated that methanol extracts of Leucas indica plant contain...