Ensuring product quality through process validation

Gap analysis for a smooth project launch leading to successful validation

To ensure a smooth project launch, it is recommended that you first compile a valid database to serve as a basis for action, based on your existing processes and equipment and considering manufacturing instructions and specifications for raw materials.

We are also happy to support you in creating this foundation with a comprehensive gap analysis or a product transfer audit.

We lay the groundwork for future validation success as early as the planning phase. We determine the appropriate type of validation (e.g., prospective or concurrent) and seamlessly integrate it into site-specific quality guidelines and SOPs. Resources are deployed efficiently and strategically where they are most relevant for product quality. This is made possible by defining the scope of validation and identifying critical process parameters (CPPs) and critical quality attributes (CQAs) based on quality-by-design (QbD) principles as early as the process design phase. We guarantee a complete history in the context of process life cycle management by use of responsibility matrices (RACI model) as well as targeted access to development reports, logbooks and where available, historical batch data.

Process validation — The starting point for continuous monitoring in accordance with regulatory requirements

In the “process validation model” we conduct process validation efficiently and in a structured manner based on EU GMP Annex 15 and the ICH Guidelines Q8, Q9, and Q10. We ensure compliance with regulatory prerequisites, such as the qualification of equipment and facilities, the validation of methods and software, and the verification of qualified media (e.g., water systems) prior to the start of process validation.

Our services flexibly cover all levels of complexity: from traditional, non-sterile dosage forms (mixing, granulation, tableting, coating) through biological processes and the biotechnological production of active pharmaceutical ingredients (APIs & excipients) to highly sensitive, aseptic sterile processes (class A cleanroom).

During the detailed course of this phase, we work with you to select the appropriate parameters, define acceptance criteria, and develop a sampling plan. In doing so, we categorize your inventory in a detailed manner:

• Process steps without direct quality relevance: Pure verification in the background enables seamless documentation for parameters that do not directly influence final product quality
• Critical process parameters (CPPs): Strict monitoring and control characterize those parameters whose variability influences product quality
• Critical quality attributes (CQAs): Target values for the validation batches define these physical, chemical, or microbiological properties for ongoing assurance
• Complex production lines and filling systems: The direct linkage of technical equipment qualification (DQ/IQ/OQ/PQ) with the actual process validation ensures the success of complex integrated systems

We use our own calibrated and validated equipment for all tests should you not have the necessary measurement equipment or statistical analysis tools.  

Our validation model adapts flexibly and dynamically to the actual number of your processes.

Following a successful project kickoff, the focus throughout the process lifecycle is on recurring monitoring of specification compliance.

This brings comprehensive monitoring of the process flow into focus, considering all production and environmental conditions as well as the qualification status of equipment and rooms. A final report provides information on the exact course and results of the process validation.

The analysis process enables the early identification of creeping process drifts and the transition from a purely point-in-time assessment of the first batches to a state-oriented, continuous process verification: establishing a database (recording relevant process parameters), data comparison (target/actual state), trend analysis (drift identification), process verification (state-oriented, continuous process verification).

Matrix and bracketing methods ensure efficiency and cost-effectiveness in process validation?

To increase efficiency, we use a matrix and bracketing method for comparable dosages, batch sizes, or packaging configurations and tailor risk analyses in direct dialogue with your experts, while simultaneously structuring communication channels and reporting.

We are happy to support you in establishing a wide variety of processes, such as actual process optimization or scale-up, adjusting timeframes, and equipment modifications (change control). Throughout the project, we seamlessly integrate these tasks as dedicated extensions into the existing workflow, as necessary changes in turn require revalidation.

Data integrity is a key factor — how do you minimize the risk?

Through our specialization in computerized system validation (CSV) and complete data integrity in accordance with the ALCOA+ principles (data governance), we sustainably minimize your risk of inspection deficiencies. CSV is an integral part of the qualification of devices and equipment as well as higher-level systems such as enterprise resource planning (ERP) and manufacturing execution systems (MES). Lack of data integrity calls into question the reliability of a process validation and must therefore be addressed when defining the concept

Valicare provides you with efficient and innovative support in meeting CSV requirements in the regulated areas:

• GMP (Good Manufacturing Practice)
• GCP (Good Clinical Practice)
• GLP (Good Laboratory Practice)
• GDP (Good Distribution Practice)

For practical and standards-compliant implementation in the GMP, GCP, GLP, or GDP sectors, we consistently and systematically rely on the globally recognized GAMP® 5 (2nd Edition) guidelines of the International Society for Pharmaceutical Engineering (ISPE®).

One of the most notable changes in this context is the consolidation of the sections on user requirements and functional specifications into a single chapter on specifying requirements. This adjustment considers the increased use of new digital technologies and automated processes. It is already integrated into our CSV approach, as is the testing strategy for life cycle phases (development, validation, production, and use), considering risk acceptance and a critical mindset.

Does Valicare’s process validation fully comply with EU GMP Annex 15 and ICH requirements?

Yes, Valicare’s process validation model is based on EU GMP Annex 15 as well as ICH guidelines Q8, Q9, and Q10, and ensures compliance with all regulatory requirements.

How does Valicare ensure data integrity during process validation?

Through comprehensive documentation based on ALCOA+ principles, CSV best practices, validated analysis tools, and GxP-compliant validation reports.

Does Valicare also support sterile processes?

Yes, Valicare supports sterile processes from the contamination control strategy through gowning qualifications to the support of regulatory audits in Grade A/B areas (EU GMP Annex 1).

What happens if process changes occur during the project duration of a process validation?

Process optimizations, scale-up, or equipment modifications can be seamlessly integrated by Valicare via change control. If necessary, revalidation can also be performed.

Can Valicare support entire sites or just individual processes?

We are flexible here. Our Valicare team can support everything from focused product transfers to large multidisciplinary sites with interconnected production lines.