The Pharmaceutical industry is under pressure to reduce cost, increase yield, and provide new solutions - but patient safety can never be compromised. To achieve these seemingly diverging goals, and to ensure growth, effective qualification and validation activities are viral.
Avertim's consultants have extensive experience supporting companies in this area. We bring in the specific expertise required for the best results.
Here's our approach.
Qualification and Validation in the Life Sciences - an overview
Continuous quality and patient safety are critical in the Life Sciences industry.
Patient health is at the core of medicine production. The pharmaceutical industry adheres to high standards and strict regulations, governing all activities from research and development to manufacturing and distribution.
Manufacturers are also pressured to reduce costs, increase yield, and provide solutions to meet unmet medical needs, but patient safety must never be compromised.
To achieve these seemingly conflicting goals, effective qualification and validation activities are vital ascertain compliance and ensure the quality and reliability of systems. This leads to both safe and effective products and to process efficiency, ensuring financially sound operations and growth of business.
Ensuring quality during ongoing change - the industry challenge
With the increasing demand for innovative drugs, vaccines, and biological agents to support patient treatment, the pharmaceutical industry faces continuous pressure to evolve.
To ensure access to the global market, and navigate the different region-based regulatory requirements, pharmaceutical companies must keep up with constantly changing regulatory landscape and standard norms.
Keeping good manufacturing practices in place while increasing efficiency is challenging. Ensuring conformity along the supply chain adds to this. Many pharmaceutical companies are seeing backlogs in their qualification and validation measures and constantly updating the documented evidence that premises, systems, and equipment are working to deliver the expected results.
Digitalisation has evolved from promising approach to a necessity. It is proven to improve efficiency, reducing manual tasks and human errors. Automation and digital solutions are not necessarily easy to establish or implement; but with a stringent focus on processes and how their results are analysed, a clear strategy can be established to take production to the next level.
Avertim's approach to qualification and validation
Avertim's expert support you in the core areas of qualification and validation management:
- Equipment qualification
- Computerised systems validation (CSV)
- Process validation
- Cleaning validation
- And analytical method validation
In the cases of equipment qualification and CSV speficically, we follow the V model of qualifications; assisting the customer in establishment of system user requirements, followed by risk assessment, and leading to establishment/performance of design, installation, operation and performance qualifications.
In addition, we support our clients with process optimisation, coordination and management.
- We also assist with change and CAPA processes to support further improvement in the ongoing qualifications
- We can manage the precise coordination of all project phases - such as project management, design phase, commissioning, qualification and validation.
- Inspection readiness and audit preparation are also in our scope.
All optimisation measures and solution development, as well as mindset building, are frequently discussed with stakeholders. This ensure successful actions in development and an efficient delivery of the overall project.
Avertim’s impact on your processes
Our consultant are successfully implementing, running and optimising validation processes across numerous projects and client sites. Every project is different; here are some examples of what we handle for our clients.
1. Process design, scale-up and backlog remediation for fully automated PCR-systems- including risk analysis, root cause analysis, definition of actions and method validation.
4. Identification of non-qualified equipment, qualification backlogs and design concepts for remediation. This include risk assessment, protocols and reports to be built for a successful audit.
2. Successful tech transfer projects including the planning (implementation) of validation studies for container closure integrity and media retention times.
5. For software validation measures, we implement CRM software (such as SuperOffice, ViewLine, SAP, GLS, CAQ, and SAGE modules). Client specific handbooks, trainings SOPs, and training videos are set-up to enable subsequent training of employees.
3. Risk assessments for extractables and leachables, cleaning validation, process validation and optimising validation plans for a major vaccine manufacturer.
6. Avertim consultants take over project management, assessing risks and identifying countermeasures while ensuring ERP implementation in time. Designed concepts are presented, for example during audits by notified body such as TÜV SÜD, focusing on MDSAP, GMP, ISO 9001, and ISO 12348. We manage the clear definition of responsabilities, timelines, and implementation of routines paramount to successful project closure.
Avertim promises Quality and efficiency in every qualification and validation project. Our goal is to support yo on your compliance journey and in the development of individual optimisation strategies. We bring in the specific experience and expertise you require for the best results.
