Oncology is a term used for the study of cancer. Cancer is a disease characterized by the uncontrollable growth of abnormal cells that destroy body tissues. As per the latest studies, the number of cancer cases in the year 2022 was 14,61,427. The rising rate of cancer has been a matter of deep concern for a long time. This requires authentic medicines and therapies to cure it.
The field of oncology drug manufacturing plays a pivotal role in the fight against cancer. With the ever-increasing demand for effective and safe treatments, it is imperative to ensure the highest standards of safety and quality throughout the manufacturing process. This blog aims to shed light on the key aspects and measures that pharmaceutical companies and regulatory bodies must undertake to guarantee the safety and efficacy of oncology drugs.
Why is safety required to manufacture oncology drugs?
Well, the answer to this includes the prevention of the hazardous effects of manufactured oncology drugs. As these drugs exhibit the following 6 characteristics while manufacturing which makes it more dangerous to use these drugs without proper safety. Those 6 characteristics are as follows:
- Carcinogenicity – Substances that cause tumour via., inhalation, ingestion or skin contact are known as carcinogens, and cause carcinogenicity.
- Teratogenicity – Capacity of a drug to cause congenital anomalies due to harmful chemicals.
- Reproductive toxicity – It is a type of toxicity that occurs when a chemical shows adverse effects on the reproductive system.
- Organ toxicity – It takes place when a chemical shows ill effects on any of the organs of the body.
- Geno toxicity – An adverse characteristic of a chemical or a substance to cause gene anomalies.
Drugs with the above characteristics can pose a potential threat to healthcare workers who are often exposed to these drugs while handling them in the course of their daily routine.
In 1979, a study was published about the mutagenic activity observed in the urine of patients who had undergone chemotherapy and also in nurses who administered chemotherapy to them. It was an evident study since occupational exposure risk was published.
The main routes for exposure to cytotoxic drugs take place via skin contact, inhalation, ingestion and sharp injuries. These routes make it more prone to exposure and harm to workers and staff working at that place.
Why is quality required to manufacture oncology drugs?
In a pharmaceutical company, quality assurance is the most basic and widely accepted concept. The basic properties of quality medicine include:
- The medicine should show the desired results and the purpose it is taken for.
- To prevent a patient from accidentally consuming an incorrect or contaminated medicine.
Providing quality medicines not only helps users heal their condition sooner and better but also helps the company maximise its production and enhance its reputation.
What are the steps that can be implemented to promote quality and safety in oncology drug manufacturing?
The following are some of the solutions that can help achieve safe and quality oncology drugs:
Stringent regulatory framework
To ensure safety and quality in oncology drug manufacturing, a robust regulatory framework is essential. Regulatory authorities, such as the Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMA) in Europe, meticulously evaluate and approve drugs before they enter the market. They assess the manufacturing processes, clinical trial data, and safety profiles of drugs, ensuring they meet predetermined standards.
Practising proper manufacturing practices
Adhering to Good Manufacturing Practices (GMP) is crucial in oncology drug manufacturing. GMP guidelines provide a comprehensive framework for pharmaceutical companies to ensure drugs are consistently produced and controlled according to quality standards. These guidelines cover various aspects, including facility design, equipment maintenance, personnel training, documentation, and quality control. Implementing GMP principles prevents contamination, cross-contamination, and other manufacturing-related issues that compromise drug safety and efficacy.
Quality Control and Quality Assurance
Implementing stringent quality control and quality assurance measures is vital to ensure oncology drugs’ safety and quality. Regular testing and analysis of raw materials, intermediates, and finished products are essential to detect any potential impurities or deviations from predefined standards. Quality control laboratories equipped with state-of-the-art instruments and staffed by qualified personnel play a crucial role in this process. Additionally, quality assurance ensures that all manufacturing processes adhere to established guidelines and regulations, mitigating the risk of errors or substandard practices.
Supplier Qualification and Validation
Oncology drugs require close collaboration with trusted and reliable suppliers. Pharmaceutical companies must establish stringent qualification and validation processes for their suppliers, including thorough audits and assessments. This ensures that raw materials and components used in drug manufacturing meet the required quality standards and are free from contamination or adulteration.
Risk Assessment and Management
A comprehensive risk assessment and management approach is essential to identify and mitigate potential risks throughout the oncology drug manufacturing process. This involves analyzing and evaluating all stages, from raw material sourcing to final product distribution. Identifying critical control points and implementing risk mitigation strategies prevent errors, contamination, and other hazards that compromise drug safety and quality. Regular audits and inspections, both internal and external, also contribute to maintaining the highest standards.
Continuous monitoring and improvement
Oncology drug manufacturing safety and quality is an ongoing process that requires continuous monitoring and improvement. Pharmaceutical companies must establish robust systems for tracking adverse events, conducting post-marketing surveillance, and promptly addressing safety concerns. Continuous improvement initiatives, such as implementing updated technologies, optimizing manufacturing processes, and enhancing staff training, enhance drug safety and quality over time.
Oncology drugs play a crucial role in cancer treatments. However, ensuring the safety and quality of these drugs is of paramount importance to protect patients’ well-being and optimize treatment outcomes. Globela Pharma manufactures oncology drugs under all the necessary conditions to ensure the best quality.
To achieve this goal, Globela Pharma adheres to regulatory standards, implements robust quality management systems, qualifies and validates suppliers, utilizes advanced analytical techniques, continuously improves processes, and provides comprehensive training and education. By adopting these strategies and best practices the company guarantees the production of safe, effective, and high-quality oncology drugs, ultimately benefiting patients and improving cancer treatment outcomes.