In the (bio-)pharmaceutical industry, product safety, efficacy and consistency are crucial and therefore, quality standards must be extremely high. To improve quality, quality management systems must be accurate and up-to-date and meet regulatory requirements and staff must be aware of all quality aspects. “Just say what you do and do what you say” is an important expression in a life sciences environment. It sounds quite simple, but lack of time, undercapacity or conflicting priorities often make it difficult to put into practice. When organizations neglect their compliance and quality responsibilities because they are simply too busy with their daily activities, inspectors may judge that they are not in compliance with GMP (Good Manufacturing Practice).

Being compliant is not the complete picture. The concept of Quality Assurance (QA) must go beyond compliance with regulations and guidelines. QA should also include the commitment to exceed compliance requirements (see for example the ICH guideline Q10 on pharmaceutical quality system). The compliance requirements should be seen as the bare minimum; under QA, the organization must also work to improve the value and rating of products, processes, and the organizational structure. In addition to striving for improvement, it is equally important to continuously maintain the desired quality level of products, processes, and services. Where minimum compliance requirements are prescribed by applicable regulatory authorities, QA quality standards are defined by the organization concerned, considering, and exceeding minimum compliance requirements where possible. Under QA, the concerned organization will continuously strive to improve all its processes and related products.

How can Progress help you with this?

We have extensive experience assisting organizations with quality improvement projects and inspections conducted by IGJ (Health Care Inspectorate), US FDA (Federal Drug Administration) or others. Our experts can help you improve your quality management system and processes, train staff in GMP standards, identify quality gaps and establish quality agreements, procedures, and work instructions. We can support you in formulating a response to the inspection findings and developing and implementing an improvement program. High product and process quality improves business efficiency, resulting in cost and time savings and smooth product release.

To identify the bottlenecks, we often start by performing a gap analysis. This allows us to compare the existing situation with what is desired. In close consultation with your organization, we can define improvement actions based on Quality Risk Management (QRM) as set out in ICH guideline Q9 on quality risk management (europa.eu).

It is especially important that your organization is actively involved in any change from the start. The organization will have to be able to operate independently and in accordance with these new agreements. Our approach will lead to successful implementation and use of practicable procedures covering staff training and qualification, self-inspection, PQR (Periodic Quality Review), change control, OOS (out of specification), deviations and CAPA (Corrective and Preventive Action). 

We can also organize the entire inspection in a front office/back office structure, with an effective division of roles between host, scribe (minutes secretary), runners and subject matter experts. The employees involved are trained in the dos and don’ts during an inspection and we conduct mock inspections in preparation. This method has more than proven its value in practice. A mock inspection is clearly defined by the US FDA: A Basic Guide to Mock FDA Inspections/Audits (thefdagroup.com)