How can you keep up with the latest validation and verification trends?

1 Know the difference

Validation and verification are often used interchangeably, but they have distinct meanings and purposes in GMP. Validation is the process of demonstrating that a product or process meets its predefined specifications and quality attributes before it is released or implemented. Verification is the process of confirming that a product or process performs as intended during or after its operation. Both validation and verification require documented evidence and follow a systematic approach, but they differ in the timing, scope and frequency of the activities.

2 Follow the guidelines

One of the best ways to keep up with the latest validation and verification trends is to follow the guidelines and recommendations issued by the relevant regulatory authorities and industry associations. For example, the US Food and Drug Administration (FDA) publishes guidance documents on various aspects of validation and verification, such as process validation, software validation, cleaning validation, analytical method validation and verification, and medical device verification and validation. Similarly, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) provides harmonised guidelines on quality topics, such as Q8, Q9, Q10 and Q11, that cover validation and verification principles and approaches. Other sources of guidance include the European Medicines Agency (EMA), the World Health Organization (WHO), the International Organization for Standardization (ISO) and the Parenteral Drug Association (PDA).

3 Adopt a risk-based approach

Another way to keep up with the latest validation and verification trends is to adopt a risk-based approach that focuses on the critical aspects of the product and process that affect the quality and patient safety. A risk-based approach allows you to prioritise the validation and verification activities based on the potential impact and likelihood of failure, and to apply the appropriate level of rigor and control. A risk-based approach also enables you to leverage existing knowledge and data, and to use innovative tools and techniques, such as quality by design (QbD), design of experiments (DoE), process analytical technology (PAT) and continuous process verification (CPV), to enhance the validation and verification outcomes.

4 Learn from the experts

Another way to keep up with the latest validation and verification trends is to learn from the experts and peers who have experience and expertise in the field. You can attend webinars, workshops, conferences and training courses that cover the latest topics and best practices in validation and verification, such as data integrity, computerised systems, biotechnology, sterile products, analytical methods and equipment qualification. You can also join professional networks and communities, such as LinkedIn groups, forums and blogs, where you can exchange ideas, insights and feedback with other practitioners and experts in validation and verification.

5 Review your practices

Another way to keep up with the latest validation and verification trends is to review your own practices and procedures regularly and compare them with the current standards and expectations. You can conduct internal audits, gap analyses, self-inspections and corrective and preventive actions (CAPAs) to identify and address any issues or deficiencies in your validation and verification activities. You can also seek external feedback and input from customers, suppliers, consultants and auditors to benchmark your performance and identify areas for improvement.

6 Stay curious

The final way to keep up with the latest validation and verification trends is to stay curious and open-minded about the new developments and opportunities in the field. You can read journals, magazines, newsletters and books that cover the latest research, innovations and case studies in validation and verification. You can also explore new technologies, platforms, methods and solutions that can enhance your validation and verification capabilities and efficiency. By staying curious, you can foster a culture of continuous learning and improvement in your organisation and in your own professional development.

7 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?