Title: Practicing AI in Quality Management System in Local Pharmaceutical Manufacturers in

Ethiopia.
Background: Quality management system (QMS) is a set of policies, procedures, and processes
that ensure the quality and safety of pharmaceutical products. QMS covers various aspects of
pharmaceutical manufacturing, such as quality control, quality assurance, validation,
documentation, risk management, and continuous improvement. QMS is essential for complying
with the regulatory requirements and meeting the customer expectations. However, QMS is often
challenged by the complexity, variability, and uncertainty of the pharmaceutical industry.
Therefore, there is a need to adopt new technologies that can enhance the efficiency,
effectiveness, and reliability of QMS. Artificial intelligence (AI) is one of the emerging
technologies that has the potential to transform QMS in the pharmaceutical industry. AI is the
ability of machines to perform tasks that normally require human intelligence, such as learning,
reasoning, and decision making. AI can provide various benefits for QMS, such as:
• Automating routine and repetitive tasks, such as data entry, data analysis, report
generation, and document management.
• Enhancing the accuracy and consistency of quality testing, such as using image
recognition, natural language processing, and machine learning to detect defects,
anomalies, and deviations.
• Improving the speed and agility of quality operations, such as using predictive analytics,
optimization algorithms, and simulation models to forecast demand, plan production,
optimize resources, and reduce waste.
• Increasing the visibility and traceability of quality processes, such as using blockchain,
cloud computing, and internet of things to store, share, and verify data across the supply
chain.
• Supporting the innovation and improvement of quality systems, such as using deep
learning, neural networks, and generative adversarial networks to discover new patterns,
insights, and solutions.
AI has been successfully applied in various domains of QMS in the pharmaceutical industry
worldwide. For example:
• Pfizer uses AI to automate its quality control process for tablet manufacturing. The AI
system uses cameras to capture images of tablets and analyzes them using image
 recognition algorithms. The system can identify defects such as cracks, chips, color
variations, and foreign particles. The system can also classify the defects according to
their severity and provide feedback to the operators for corrective actions1.
• Novartis uses AI to optimize its quality assurance process for drug development. The AI
system uses natural language processing to extract information from scientific literature
and regulatory documents. The system can then generate summaries and
recommendations for quality-related issues such as stability testing, impurity profiling,
and specification setting2.
• Merck uses AI to improve its quality risk management process for drug manufacturing.
The AI system uses machine learning to analyze historical data from various sources such
as production records, quality reports, customer complaints, and audits. The system can
then identify potential risks and their root causes. The system can also prioritize the risks
based on their impact and likelihood3.
However, the adoption of AI in QMS in local pharmaceutical manufacturers in Ethiopia is still
limited. This is due to various barriers such as lack of awareness, expertise, infrastructure, data
availability, regulatory guidance, and ethical considerations. Therefore, there is a need to explore
the opportunities and challenges of practicing AI in QMS in local pharmaceutical manufacturers
in Ethiopia.
Objectives: The main objective of this study is to practice AI in QMS in local pharmaceutical
manufacturers in Ethiopia. The specific objectives are:
• To assess the current status and readiness of QMS in local pharmaceutical manufacturers
in Ethiopia.
• To identify the key use cases and applications of AI in QMS in local pharmaceutical
manufacturers in Ethiopia.
• To design and implement pilot projects of AI in QMS in selected local pharmaceutical
manufacturers in Ethiopia.
• To evaluate the performance and impact of AI in QMS in selected local pharmaceutical
manufacturers in Ethiopia.
• To develop a roadmap and framework for scaling up AI in QMS in local pharmaceutical
manufacturers in Ethiopia.
Methods: This study will use a mixed-methods design and a participatory approach. The study
population will consist of local pharmaceutical manufacturers in Ethiopia that are involved in the
production of human or veterinary medicines. The sample size will be calculated based on the
number of local pharmaceutical manufacturers and their characteristics such as size, product
portfolio, market share, etc. The sampling technique will be purposive sampling. The data
collection methods will include:
• A desk review using secondary sources such as databases, reports, publications, etc. to
assess the current status and readiness of QMS in local pharmaceutical manufacturers in
Ethiopia.
• A survey using a structured questionnaire to collect data on the perceptions, attitudes, and
practices of the stakeholders such as managers, quality professionals, operators, etc.
regarding AI and QMS in local pharmaceutical manufacturers in Ethiopia.
• A focus group discussion using a semi-structured guide to identify the key use cases and
applications of AI in QMS in local pharmaceutical manufacturers in Ethiopia.
• A case study using a multiple-case design to design and implement pilot projects of AI in
QMS in selected local pharmaceutical manufacturers in Ethiopia.
• A cost-benefit analysis using a spreadsheet model to evaluate the performance and impact
of AI in QMS in selected local pharmaceutical manufacturers in Ethiopia.
Expected outcomes: The expected outcomes of this study are:
• A comprehensive report on the current status and readiness of QMS in local
pharmaceutical manufacturers in Ethiopia.
• A list of key use cases and applications of AI in QMS in local pharmaceutical
manufacturers in Ethiopia.
• A demonstration of pilot projects of AI in QMS in selected local pharmaceutical
manufacturers in Ethiopia.
• A quantification of the performance and impact of AI in QMS in selected local
pharmaceutical manufacturers in Ethiopia.
• A roadmap and framework for scaling up AI in QMS in local pharmaceutical
manufacturers in Ethiopia.
• Publications in peer-reviewed journals and presentations at scientific conferences.
Budget: The estimated budget for this study will include the costs of data collection tools,
transportation, personnel, incentives, equipment, software, overheads.
Timeline: The estimated duration for this study is 12 months, which includes the following
activities:
• Month 1: Literature review and proposal writing
• Month 2: Ethical clearance and administrative approval
• Month 3: Data collection tools development
• Month 4-6: Data collection
• Month 7-9: Data analysis
• Month 10: Report writing
• Month 11: Publication and dissemination
• Month 12: Evaluation and feedback
References:
: Pfizer. How Pfizer is using AI to improve quality control. [Online]. Available at: 1. Accessed on
October 17, 2021.
: Novartis. How Novartis is using AI to streamline drug development. [Online]. Available at: 2.
Accessed on October 17, 2021.
: Merck. How Merck is using AI to enhance quality risk management. [Online]. Available at: 3.
Accessed on October 17, 2021