ABM Mahfuz ul Alam
Following my graduation from Dhaka University, I seized the opportunity to advance my research in medicinal chemistry, with a particular focus on anti-diabetic and anti-cancer plant materials. During this period, I extensively utilized a variety of highly sophisticated analytical techniques such as HPLC, GC-MS, NMR, UV, and FTIR. Armed with hands-on experience in operating this equipment, I embarked on my professional journey at Novartis Bangladesh Limited as an Officer, QC.
My contributions proved pivotal to Novartis, resulting in my swift promotion to the position of Manager, QC. At Novartis, I initially served as a key team member, ensuring successful EU GMP and ANVISA inspections, alongside numerous GQA inspections. Since the mid-2004s, I have led the QC team at Novartis Bangladesh Limited, orchestrating successful inspections by regulatory bodies including EU GMP, ANVISA, MCC, GQA, and various customer inspections.
Driven by a desire to share my expertise and bolster local companies in Bangladesh, I transitioned to ACI Limited in 2009 as a Quality Assurance Manager. Here, I led both the QA and QC teams during a period of substantial revenue growth for the company. In 2013, I was entrusted with spearheading ACI Limited's foray into stringent regulatory markets, particularly the USA. Tasked with preparing a comprehensive master plan for ACI HealthCare Limited, I was subsequently promoted to General Manager, Quality Operations in October 2014.
In this elevated role, I took charge of assembling diverse teams encompassing QA, QC, R&D, Validation, and Regulatory Affairs, comprising fresh graduates whom I trained rigorously for knowledge and skill enhancement. Within a short span, these teams evolved into highly competent units capable of delivering innovative products compliant with the standards of the USA and EU markets. Concurrently, I led the development of the Quality Management System (QMS) and related documentation for the company, culminating in the attainment of GMP certification from US FDA and INFARMED, Portugal. Furthermore, our efforts secured approval for several Abbreviated New Drug Applications (ANDAs) and Marketing Authorizations (MAs) from these regulatory authorities.
Amidst these endeavors, I successfully completed my PhD from the University of Dhaka. Presently, I am actively involved in steering various projects within the company, including Oncology and Bio Specialty, while diligently fulfilling my current responsibilities to ensure the delivery of high-quality products to the USA market.
Throughout my career, I've consistently demonstrated strong leadership qualities, proactively seeking opportunities to lead by example and motivate others to achieve common goals. With a keen eye for potential, I've nurtured talent within teams and facilitated growth by empowering individuals to reach their full capabilities.
My approach is centered on adding value at every opportunity, whether through innovative solutions, process improvements, or strategic insights. I thrive on challenges, viewing them as opportunities for growth and development, and I'm always ready to tackle them head-on with determination and a positive attitude.
Phone: +8801730021082
Address: Sonargaon Museum Gate-1 Road, Treepordi,
Sonargaon
My contributions proved pivotal to Novartis, resulting in my swift promotion to the position of Manager, QC. At Novartis, I initially served as a key team member, ensuring successful EU GMP and ANVISA inspections, alongside numerous GQA inspections. Since the mid-2004s, I have led the QC team at Novartis Bangladesh Limited, orchestrating successful inspections by regulatory bodies including EU GMP, ANVISA, MCC, GQA, and various customer inspections.
Driven by a desire to share my expertise and bolster local companies in Bangladesh, I transitioned to ACI Limited in 2009 as a Quality Assurance Manager. Here, I led both the QA and QC teams during a period of substantial revenue growth for the company. In 2013, I was entrusted with spearheading ACI Limited's foray into stringent regulatory markets, particularly the USA. Tasked with preparing a comprehensive master plan for ACI HealthCare Limited, I was subsequently promoted to General Manager, Quality Operations in October 2014.
In this elevated role, I took charge of assembling diverse teams encompassing QA, QC, R&D, Validation, and Regulatory Affairs, comprising fresh graduates whom I trained rigorously for knowledge and skill enhancement. Within a short span, these teams evolved into highly competent units capable of delivering innovative products compliant with the standards of the USA and EU markets. Concurrently, I led the development of the Quality Management System (QMS) and related documentation for the company, culminating in the attainment of GMP certification from US FDA and INFARMED, Portugal. Furthermore, our efforts secured approval for several Abbreviated New Drug Applications (ANDAs) and Marketing Authorizations (MAs) from these regulatory authorities.
Amidst these endeavors, I successfully completed my PhD from the University of Dhaka. Presently, I am actively involved in steering various projects within the company, including Oncology and Bio Specialty, while diligently fulfilling my current responsibilities to ensure the delivery of high-quality products to the USA market.
Throughout my career, I've consistently demonstrated strong leadership qualities, proactively seeking opportunities to lead by example and motivate others to achieve common goals. With a keen eye for potential, I've nurtured talent within teams and facilitated growth by empowering individuals to reach their full capabilities.
My approach is centered on adding value at every opportunity, whether through innovative solutions, process improvements, or strategic insights. I thrive on challenges, viewing them as opportunities for growth and development, and I'm always ready to tackle them head-on with determination and a positive attitude.
Phone: +8801730021082
Address: Sonargaon Museum Gate-1 Road, Treepordi,
Sonargaon
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The analysis provides specific quantitative values that shed light on the severity and repetition of observed issues. Subpart J stands out with the highest single repetition, registering at 114, suggesting persistent challenges that warrant close attention. Furthermore, the sum of the top three observations, totaling 1067 across Subparts J, F, and I, highlights the cumulative impact of these areas on overall compliance.
This quantitative approach contributes to a nuanced understanding of compliance challenges, allowing stakeholders to strategically allocate resources. The study emphasizes the need for targeted interventions,
particularly in Subparts J, F, and I, where elevated counts and percentages signal potential systemic issues. The concentration of observations in the top three subparts underscores the importance of collaborative efforts among stakeholders to proactively address and rectify these challenges, fostering sustained improvements in regulatory compliance and upholding the integrity of FDA-regulated products.
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 between isocratic and gradient HPLC methods should be considered.
Isocratic HPLC is simpler and faster, suitable for samples with well-separated peaks. On
the other hand, gradient HPLC offers enhanced resolution for complex samples with
closely eluting peaks and provides more flexibility for method development.
Injector loop size, tubing, detector selection, injection volume, temperature, and mobile
phase composition are other critical factors influencing resolution. Each of these factors
must be carefully optimized to achieve the desired separation. Injector loop size affects
the sample volume injected into the system, while tubing influences system pressure
and band broadening. Detector selection determines the sensitivity and selectivity of the
analysis. Injection volume affects peak shape and resolution. Temperature control is
important for controlling analyte retention and selectivity. Finally, the mobile phase
composition, consisting of solvents and additives, greatly impacts separation selectivity.
To optimize resolution, method development requires systematic troubleshooting. By
evaluating and adjusting these factors, resolution issues can be effectively resolved.
Troubleshooting strategies include identifying and addressing peak broadening, tailing,
fronting, and overlapping peaks.
In conclusion, achieving optimal chromatographic resolution in HPLC analysis involves
careful consideration and optimization of various factors. By understanding the
principles behind chromatographic resolution and employing appropriate techniques,
researchers and analysts can obtain reliable and accurate results in their HPLC analyses.
stability, and overall product performance. However, the quality of excipients, including the presence of
contaminants and impurities, can significantly impact human health. This abstract highlight the impact of excipient contaminants and impurities on adverse drug reactions and patient safety.
Contaminants and impurities in excipients can originate from various sources, such as raw materials, manufacturing processes, or storage conditions. These can include elemental impurities, residual solvents, genotoxic impurities, allergens, and other harmful substances. When present in pharmaceutical formulations, these contaminants and impurities can lead to adverse effects on human health.
Case studies have demonstrated the potential risks associated with excipient contaminants and impurities.
Examples include the diethylene glycol (DEG) contamination incident in Nigeria, which resulted in fatalities due to substandard excipients. Other case studies have highlighted the adverse effects of elemental impurities, such as heavy metals, on organ toxicity and neurotoxicity.
Genotoxic impurities present in excipients have been linked to potential genetic abnormalities and carcinogenic effects. Allergens in excipients can trigger allergic reactions in susceptible individuals, ranging from mild symptoms to life-threatening anaphylaxis. Additionally, residual solvents in excipients, if not properly removed during manufacturing, can lead to systemic toxicity and adverse reactions.
To mitigate the risks associated with excipient contaminants and impurities, stringent quality control measures and adherence to regulatory standards are essential. Robust testing and screening processes, as well as proper sourcing and storage of excipients, are crucial to ensure their purity and minimize adverse effects on human health.
In conclusion, the quality of excipients has a significant impact on human health. The presence of contaminants and impurities can lead to adverse drug reactions and jeopardize patient safety. Ensuring excipient quality through comprehensive testing, proper sourcing, and adherence to regulatory standards is imperative to mitigate these risks and ensure the overall safety and efficacy of pharmaceutical products.
manufacturing high-quality and reliable pharmaceucal products. The quality and reliability of
these products are of utmost importance to ensure their efficacy, safety, and paent well-being.
However, despite significant advancements in technology and stringent regulatory frameworks,
errors in pharmaceucal manufacturing connue to occur, posing risks to paent safety and
product quality.
In recent years, there has been a growing recognion of the pivotal role played by human factors
in ensuring the quality and reliability of pharmaceucal products. Human factors encompass the
study of how human capabilies, limitaons, and behaviors interact with systems, processes, and
environments. It involves understanding human cognion, percepon, aenon, and decisionmaking,
and applying this knowledge to design systems that minimize the risk of errors and
opmize human performance.
This journal aims to explore the various aspects of human factors and their impact on the quality
and reliability of pharmaceucal products. It highlights the significance of aenon management,
cognive load reducon, effecve communicaon, and human-machine interface design in
migang human errors and ensuring product excellence.
The journal will delve into both intenonal and unintenonal human errors, considering factors
such as system-induced errors, design-induced errors, and environment-induced errors that can
contribute to aenon gaps and compromise product quality. It will examine the underlying
causes of these errors, including factors such as laziness, memory gaps, conflict with peers or
supervisors, family issues, omission gaps, absent-mindedness, and organizaonal culture.
Furthermore, the journal will present case studies, empirical research, and praccal strategies for
integrang human factors principles into pharmaceucal manufacturing processes. It will explore
the role of training and competency enhancement, workflow opmizaon, human-machine
interface redesign, and the creaon of a culture that values aenon to detail in prevenng errors
and ensuring consistent product quality.
By addressing the human factors aspects of pharmaceucal manufacturing, this journal seeks to
foster a greater understanding of the role of human behavior, cognion, and the work environment in shaping product quality and reliability. It will provide valuable insights and
praccal recommendaons for pharmaceucal companies, regulatory agencies, and researchers
to implement effecve measures that enhance aenon management, reduce errors, and
improve paent safety.
The importance of human factors in pharmaceucal manufacturing cannot be overstated. By
integrang human factors principles into the design, development, and operaon of
pharmaceucal processes, we can create a culture of quality and reliability that benefits paents,
healthcare providers, and the pharmaceucal industry as a whole. This journal serves as a
plaorm for knowledge exchange and collaboraon, aiming to contribute to the advancement of
human factors in the pharmaceucal industry and the connued improvement of product quality
and paent outcomes.
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 regulations, issued and enforced by the U.S. Food and Drug
Administration (FDA), provide a robust framework designed to ensure the quality, safety, and efficacy of
pharmaceutical products throughout their lifecycle.
The primary objective of 21 CFR Part 211 is to establish and maintain a uniform standard of manufacturing
practices for finished pharmaceuticals. By doing so, the regulation seeks to safeguard public health by
assuring that drug products are consistently produced with the appropriate identity, strength, quality, and
purity. As an integral component of the broader cGMP framework, these regulations guide
pharmaceutical manufacturers in creating and maintaining controlled manufacturing environments,
rigorous quality control processes, and meticulous documentation practices.
This introduction sets the stage for a deeper exploration of 21 CFR Part 211, emphasizing its critical role
in upholding the integrity of the pharmaceutical manufacturing process. As we delve into its key provisions
and implications, it becomes evident that adherence to these regulations is not merely a regulatory
requirement but a fundamental commitment to delivering pharmaceutical products that meet the highest
standards of quality and safety.
The analysis provides specific quantitative values that shed light on the severity and repetition of observed issues. Subpart J stands out with the highest single repetition, registering at 114, suggesting persistent challenges that warrant close attention. Furthermore, the sum of the top three observations, totaling 1067 across Subparts J, F, and I, highlights the cumulative impact of these areas on overall compliance.
This quantitative approach contributes to a nuanced understanding of compliance challenges, allowing stakeholders to strategically allocate resources. The study emphasizes the need for targeted interventions,
particularly in Subparts J, F, and I, where elevated counts and percentages signal potential systemic issues. The concentration of observations in the top three subparts underscores the importance of collaborative efforts among stakeholders to proactively address and rectify these challenges, fostering sustained improvements in regulatory compliance and upholding the integrity of FDA-regulated products.
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 between isocratic and gradient HPLC methods should be considered.
Isocratic HPLC is simpler and faster, suitable for samples with well-separated peaks. On
the other hand, gradient HPLC offers enhanced resolution for complex samples with
closely eluting peaks and provides more flexibility for method development.
Injector loop size, tubing, detector selection, injection volume, temperature, and mobile
phase composition are other critical factors influencing resolution. Each of these factors
must be carefully optimized to achieve the desired separation. Injector loop size affects
the sample volume injected into the system, while tubing influences system pressure
and band broadening. Detector selection determines the sensitivity and selectivity of the
analysis. Injection volume affects peak shape and resolution. Temperature control is
important for controlling analyte retention and selectivity. Finally, the mobile phase
composition, consisting of solvents and additives, greatly impacts separation selectivity.
To optimize resolution, method development requires systematic troubleshooting. By
evaluating and adjusting these factors, resolution issues can be effectively resolved.
Troubleshooting strategies include identifying and addressing peak broadening, tailing,
fronting, and overlapping peaks.
In conclusion, achieving optimal chromatographic resolution in HPLC analysis involves
careful consideration and optimization of various factors. By understanding the
principles behind chromatographic resolution and employing appropriate techniques,
researchers and analysts can obtain reliable and accurate results in their HPLC analyses.
stability, and overall product performance. However, the quality of excipients, including the presence of
contaminants and impurities, can significantly impact human health. This abstract highlight the impact of excipient contaminants and impurities on adverse drug reactions and patient safety.
Contaminants and impurities in excipients can originate from various sources, such as raw materials, manufacturing processes, or storage conditions. These can include elemental impurities, residual solvents, genotoxic impurities, allergens, and other harmful substances. When present in pharmaceutical formulations, these contaminants and impurities can lead to adverse effects on human health.
Case studies have demonstrated the potential risks associated with excipient contaminants and impurities.
Examples include the diethylene glycol (DEG) contamination incident in Nigeria, which resulted in fatalities due to substandard excipients. Other case studies have highlighted the adverse effects of elemental impurities, such as heavy metals, on organ toxicity and neurotoxicity.
Genotoxic impurities present in excipients have been linked to potential genetic abnormalities and carcinogenic effects. Allergens in excipients can trigger allergic reactions in susceptible individuals, ranging from mild symptoms to life-threatening anaphylaxis. Additionally, residual solvents in excipients, if not properly removed during manufacturing, can lead to systemic toxicity and adverse reactions.
To mitigate the risks associated with excipient contaminants and impurities, stringent quality control measures and adherence to regulatory standards are essential. Robust testing and screening processes, as well as proper sourcing and storage of excipients, are crucial to ensure their purity and minimize adverse effects on human health.
In conclusion, the quality of excipients has a significant impact on human health. The presence of contaminants and impurities can lead to adverse drug reactions and jeopardize patient safety. Ensuring excipient quality through comprehensive testing, proper sourcing, and adherence to regulatory standards is imperative to mitigate these risks and ensure the overall safety and efficacy of pharmaceutical products.
manufacturing high-quality and reliable pharmaceucal products. The quality and reliability of
these products are of utmost importance to ensure their efficacy, safety, and paent well-being.
However, despite significant advancements in technology and stringent regulatory frameworks,
errors in pharmaceucal manufacturing connue to occur, posing risks to paent safety and
product quality.
In recent years, there has been a growing recognion of the pivotal role played by human factors
in ensuring the quality and reliability of pharmaceucal products. Human factors encompass the
study of how human capabilies, limitaons, and behaviors interact with systems, processes, and
environments. It involves understanding human cognion, percepon, aenon, and decisionmaking,
and applying this knowledge to design systems that minimize the risk of errors and
opmize human performance.
This journal aims to explore the various aspects of human factors and their impact on the quality
and reliability of pharmaceucal products. It highlights the significance of aenon management,
cognive load reducon, effecve communicaon, and human-machine interface design in
migang human errors and ensuring product excellence.
The journal will delve into both intenonal and unintenonal human errors, considering factors
such as system-induced errors, design-induced errors, and environment-induced errors that can
contribute to aenon gaps and compromise product quality. It will examine the underlying
causes of these errors, including factors such as laziness, memory gaps, conflict with peers or
supervisors, family issues, omission gaps, absent-mindedness, and organizaonal culture.
Furthermore, the journal will present case studies, empirical research, and praccal strategies for
integrang human factors principles into pharmaceucal manufacturing processes. It will explore
the role of training and competency enhancement, workflow opmizaon, human-machine
interface redesign, and the creaon of a culture that values aenon to detail in prevenng errors
and ensuring consistent product quality.
By addressing the human factors aspects of pharmaceucal manufacturing, this journal seeks to
foster a greater understanding of the role of human behavior, cognion, and the work environment in shaping product quality and reliability. It will provide valuable insights and
praccal recommendaons for pharmaceucal companies, regulatory agencies, and researchers
to implement effecve measures that enhance aenon management, reduce errors, and
improve paent safety.
The importance of human factors in pharmaceucal manufacturing cannot be overstated. By
integrang human factors principles into the design, development, and operaon of
pharmaceucal processes, we can create a culture of quality and reliability that benefits paents,
healthcare providers, and the pharmaceucal industry as a whole. This journal serves as a
plaorm for knowledge exchange and collaboraon, aiming to contribute to the advancement of
human factors in the pharmaceucal industry and the connued improvement of product quality
and paent outcomes.
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 regulations, issued and enforced by the U.S. Food and Drug
Administration (FDA), provide a robust framework designed to ensure the quality, safety, and efficacy of
pharmaceutical products throughout their lifecycle.
The primary objective of 21 CFR Part 211 is to establish and maintain a uniform standard of manufacturing
practices for finished pharmaceuticals. By doing so, the regulation seeks to safeguard public health by
assuring that drug products are consistently produced with the appropriate identity, strength, quality, and
purity. As an integral component of the broader cGMP framework, these regulations guide
pharmaceutical manufacturers in creating and maintaining controlled manufacturing environments,
rigorous quality control processes, and meticulous documentation practices.
This introduction sets the stage for a deeper exploration of 21 CFR Part 211, emphasizing its critical role
in upholding the integrity of the pharmaceutical manufacturing process. As we delve into its key provisions
and implications, it becomes evident that adherence to these regulations is not merely a regulatory
requirement but a fundamental commitment to delivering pharmaceutical products that meet the highest
standards of quality and safety.