What are the common challenges and risks in performing OQ in pharma?

1 Planning and documentation

One of the first challenges in performing OQ is to define the scope, objectives, and acceptance criteria of the testing, and to document them clearly and consistently. Without a proper plan and documentation, you may face confusion, ambiguity, duplication, or gaps in the testing activities, which can lead to errors, delays, or non-conformities. To avoid this, you should follow a structured approach based on the system requirements, risk assessment, and regulatory standards, and use templates, checklists, and traceability matrices to ensure completeness and traceability.

2 Test design and execution

Another challenge in performing OQ is to design and execute the test cases that cover all the relevant scenarios and conditions that the system may encounter in its operational environment. This includes normal, abnormal, and worst-case situations, as well as boundary, stress, and performance tests. Designing and executing these tests can be complex, time-consuming, and resource-intensive, especially if the system has multiple functions, interfaces, or configurations. To overcome this challenge, you should use a risk-based approach to prioritize the most critical and frequent scenarios, and use automation tools, test scripts, or simulators to reduce manual effort and human error.

4 Change management and revalidation

A fourth challenge in performing OQ is to manage the changes that may occur in the system or its environment during or after the testing, and to determine the impact and need for revalidation. Changes can be caused by various reasons, such as bug fixes, enhancements, upgrades, patches, configuration changes, or environmental changes. Changes can affect the functionality, performance, or compatibility of the system, and may introduce new risks or errors. To deal with this challenge, you should establish a change management process that defines the roles, responsibilities, procedures, and criteria for identifying, evaluating, approving, implementing, documenting, and verifying the changes, and for assessing the extent and frequency of revalidation.

5 Communication and collaboration

A fifth challenge in performing OQ is to communicate and collaborate effectively with the various stakeholders involved in the validation process, such as the system owners, users, developers, vendors, testers, quality assurance, regulatory affairs, or auditors. Communication and collaboration are essential for ensuring the alignment, coordination, and transparency of the validation activities, as well as for resolving any issues, discrepancies, or conflicts that may arise. However, communication and collaboration can be hindered by factors such as different expectations, perspectives, languages, cultures, or locations of the stakeholders. To overcome this challenge, you should use clear and consistent terminology, formats, and standards for the validation documents and reports, and use appropriate tools, channels, and methods for sharing information and feedback.