In the pharmaceutical industry, even a small error can affect patient health and safety, which is why risk management also includes strict compliance with laws, regulations, and obligations. For Medimo, risk management is part of everyday work.
– In the pharmaceutical industry, the goal of risk management is to prevent mistakes, protect patient safety, and ensure the quality of medicines, says Sanna Tuhkala, Quality Expert, Qualified Person (QP) of Medimo.
According to Sanna Tuhkala, risk management done properly helps prepare for unexpected events and reduce their impact. In addition to patient safety and regulatory confidence, risk management also improves the efficient use of resources.
Resources can include workforce, time, money, materials, and equipment. With risk management, these resources are used correctly, avoiding unnecessary errors and corrective actions.
Staying ahead in safety
Before a medicine reaches the consumer’s medicine cabinet, it has gone through a long process, with risks assessed at every stage of production.
Potential risks are identified already in early product development and design, as well as in planning and validation of the manufacturing process. Distribution, storage, and the handling of deviations and quality defects are also carefully considered.
Risk assessment vs. risk management
The terms risk assessment and risk management are often confused. While risk assessment focuses on identifying what could go wrong and how serious an error could be if it happened, risk management is a broad process that includes assessing risks, making decisions, taking action, and following up to keep risks as small as possible.
Identifying risks early
How can we ensure that risks are identified in time? In pharmacovigilance, risk management is based on proactive planning and documentation. Everything starts with people: ensuring staff competence is up to date. This also includes creating a culture where risks and their assessments can be discussed openly.
Backup systems and compensating controls are key in identifying risks. For example, parallel checks or additional monitoring may be performed. Risk matrices and classifications help evaluate probability and impact.
When implementing a new IT system, risk analysis helps identify critical aspects and ensure they are properly addressed in configuration, testing, and staff training.
Stopping to reflect on errors and learning from them is important in every industry, but in quality risk management it is critical. Lessons can be drawn from analyzing deviations and through CAPA (Corrective and Preventive Actions).
How regulations shape our work
Regulatory requirements demand that the results of risk management are documented. The results must be well justified and traceable. Regulations can also bring new perspectives.
– A new regulatory requirement can reveal risks that were not previously identified, or that were considered minor, Sanna Tuhkala explains.
Risk management is an essential part of quality assurance in the manufacture of pharmaceuticals and medical devices, and it is a mandatory requirement under GMP (Good manufacturing practice). It is carried out according to strict international standards, such as:
- ICH Q9 – Quality Risk Management: The key guideline referenced by other GMP requirements
- ICH Q10 Pharmaceutical Quality System: Highlights the role of risk management within the quality system
- EudraLex Vol. 4: Defines applications of risk management in handling deviations, change control, and contamination prevention
- EU GMP Annex 1 – Sterile Products: Special emphasis on risk management in aseptic production
- EMA and other authority guidelines: Stress the risk-based approach in areas such as advanced therapy medicinal products (ATMPs)
Think ahead, avoid risks
Risk management is an essential part of everyday operations for a company in the pharmacovigilance field.
– Risk management is done so that decisions are based on knowledge, not guesswork, says Sanna Tuhkala.
According to Tuhkala, in addition to meeting regulatory requirements, risk management is also a smarter and safer way of working. When risks are known in advance, they can be controlled, and operations can continue even in unexpected situations.
