Process validation simple explained

The aim of all processes is the repetitive production of identical, previously defined results. The processes should be controlled in such a way that consistent quality is achieved. Because it is intended to ensure precisely this, validation is very important in the industry. It does not always have to involve the term "validation", but the procedures are very similar.

For example, proving the process capability of manufacturing processes is comparable to the "validation" procedure. These can be planning, manufacturing, testing or logistics processes that are commonplace in a company. The aim is to validate these processes, i.e. to design them in such a way that they always deliver the desired quality results.

Process validation serves to confirm in advance that the processes are capable of doing so. The documentation for this property is the process validation. The requirements for (process) validation vary from industry to industry, but generally follow the same pattern.

Validation not only meets the regulations of the GxP environment, but also frequently occurs in self-regulated industries (e.g. automotive industry). Process validation is a fundamental building block in these sensitive industries. It ensures that processes deliver consistent results again and again (i.e. reproducibly).

It is therefore established that an end product can always be manufactured in the same way under constant conditions. On the one hand, this is intended to ensure consistent product quality and, on the other, to save costs through reliable production.

In the pharmaceutical environment, process validation focuses primarily on patient safety. The primary aim is to achieve good process stability and quality and to confirm and document this in the course of validation. Process validation also pursues other goals:

• Methodology in order to be able to implement new measures or changes in a planned and targeted manner.
• Documented basis over the entire life cycle.
• Confirmation that the process implementation actually works as planned in advance.
• Identification of implementation errors and their correction.
• Learning from mistakes made and preventing errors from being found during operational application.
• Reducing costs through process stability (directly achieving the required quality and avoiding corrections).
• Ensuring patient safety in pharmacy and medical devices.

The greatest benefit of process validation is that it is an aid to process control and therefore primarily brings cost benefits by avoiding errors and therefore costs. Other expenses, e.g. due to stricter quality controls, can also be reduced as a result of the increased process reliability. This is because inspections can be suspended or the scope of inspections reduced.
The stringent requirement for documentation offers a further benefit in that the status quo of processes and procedures can be tracked at any time (e.g. when training new employees) and changes can in turn be evaluated and documented more easily. This also leads to

• Processes are easier to understand and more comprehensible
• users trust the systems they use
• and, thanks to controlled systems, there is greater information security.

In principle, the procedure is based on defining requirements (for a process, a machine or system, a computer system, etc.) (requirements specification). In addition, it is described how these are implemented and which facilities are required for this (e.g. rights, parameterization) (functional specification). The implementation is documented and the functions and fulfillment of the requirements are tested and documented using defined test plans.

This process is often represented in a V-model. In the GMP environment, a best practice was created with GAMP (Good Automated Manufacturing Practice, currently in version 5), which is also often used as a standardized procedure in other industries (e.g. medical devices) in process validation.

In this context, the terms refer to the digital world of computers. While process validation in the field of computer systems proves that a process delivers predefined results, qualification deals with hardware and the system environment.

Qualification is a proof of suitability that hardware and infrastructure are functioning properly. It states that the equipment can do what is required of it.

As described, process validation initially means the confirmation of process capability. However, numerous factors have an influence on the quality of a process, such as the process design, the associated machines and systems, the operating personnel or other systems, such as computers. This is what we call the process validation of a production process, for example.

If a production process is supported by a computer system, the use of the computer system must also be validated, which is called computer system validation (CSV). CSV therefore means the validation of a process with regard to the use of a computer system.

Verification is the process of using objective means to check whether certain properties have been successfully fulfilled. The process can relate to products or components, for example. In other words, it is checked whether a product fully meets the specifications that were defined in advance.

Process validation, on the other hand, is about checking that a process can repeatedly achieve predefined results.

In relation to software solutions, this is referred to as computer system validation. This is based on GMP guidelines, which stipulate that:

• Computer systems or software must be used in a validated manner
• software must be able to achieve exact, continuous and reproducible results

The topic of computer system validation is also relevant to the FDA: software validation must therefore confirm that software specifications are implemented in accordance with user requirements and the intended use and that requirements are consistently met. Objective evidence is examined and provided for this purpose.

Process validation is particularly relevant in the pharmaceutical and medical device industries. The reason for this is the required and necessary precision. The pharmaceutical and medical technology sectors are sensitive areas - the exact achievement of pre-defined criteria is extremely important. Only in this way can products, such as medicines, be manufactured reliably and consumers can be assured of consistent product quality.

Process validation in pharmaceutical manufacturing

Process validation in pharmaceutical manufacturing ensures that the end product always meets the required quality standards and achieves the same result under identical environmental conditions such as temperature. Each new product, regardless of the use of identical or similar equipment, requires a new process validation.

A specific validation plan is developed for the implementation of such a process validation, which must comply with the legal guidelines (e.g. EU-GMP, FDA or PIC/S). The procedures in this plan must comply with the process validation work instructions. Compliance is checked by responsible persons such as the laboratory manager or the head of quality assurance and confirmed by signature. Once the validation plan has been implemented, a detailed report is drawn up which records and evaluates the results and any deviations. This report is similar to a detailed test report, such as those prepared for vehicle inspections. Only validated methods and processes may be used for the production and control of medicines intended for sale.

With the increasing relevance of computerized systems in pharmaceutical production, these must also comply with the required regulations and be validated. These include ERP systems, document management systems, manufacturing execution systems and laboratory information management systems.

Process validation of medical devices

The process validation of medical devices is a crucial process to ensure the safety and effectiveness of these products. In order to be approved for the market, medical devices must comply with a number of standards, including ISO 13485, which defines the requirements for a quality management system, and ISO 14971 for risk management.

The validation process includes careful testing and documentation of all design, production and use phases. Not only the physical components of the product are examined, but also any software or computer-aided systems. These must be checked for correct functionality, user-friendliness and integration into existing systems.

The methodology follows a structured approach: from the definition of requirements through several test phases to the final evaluation. This ensures that the medical device consistently delivers the expected performance and complies with legal requirements.

The process validation of ERP systems is a crucial process to ensure that these systems meet the specific requirements of an organization and function reliably.

However, there are various challenges involved:

• Complexity of ERP systems: ERP systems consist of numerous modules and functions that are interconnected. This complexity makes it difficult to carry out a comprehensive and precise validation, as all possible scenarios and usage contexts must be taken into account.
• Frequent updates and adjustments: Regular changes to ERP systems pose a particular challenge. Each modification carries the risk of creating new errors that render the previous validation invalid and require additional effort.
• Data integrity and interface problems: Inconsistent data or poorly integrated interfaces can make process validation much more difficult. If data integrity or system interoperability is compromised, this can jeopardize the reliability of the entire ERP system.

Overall, the validation of ERP systems represents a complex balance between a thorough review and the associated time and financial costs, which remains an ongoing challenge for companies.

Yaveon 365 stands out as an ERP system that meets the specific requirements of computer system validation in regulated industries such as medical devices & pharmaceuticals.

• Comprehensive documentation for computer system validation: Every process is documented, which is a basic requirement for computer system validation.
• Future-proof through validation-friendly updates: Thanks to the regular, validation-friendly updates and the intelligent interface architecture, companies can be sure that Yaveon ProBatch not only meets current regulatory requirements, but also those of the future.
• Proven quality and reliability: Many years of know-how and regular quality audits by our customers confirm the quality and reliability of the software.
• Seamless integration and customization: With its specialized functions and comprehensive modularity, Yaveon ProBatch enables seamless integration and customization to individual business processes without compromising process validation.
• Highest standards for data integrity and compliance: The software is designed to meet the highest standards for data integrity and compliance, reducing validation efforts and minimizing the risk of errors.