To comply with current legislation, you need to qualify and validate your products, processes, systems, equipment and software. By doing this, you guarantee the quality and safety of your complete product cycle from design & preparation to transport.
Producing pharmaceutical and biotechnological products is increasingly challenging as a result of stringent regulatory requirements and technological developments. Our consultants have extensive experience with quality assurance, quality control, compliance, internal and external audits and regulatory affairs:
- Quality Assurance (QA): our quality assurance consultants can help you with validation and with setting up and maintaining compliance with your quality systems (change control and deviation handling). Our senior registered auditors can help you prepare for audits in the most efficient way, with or without the help of mock inspections. We can also conduct official audits.
- Quality Control (QC): our experienced QC consultants can help you with the qualification and validation of computerized systems, lab equipment, analytical methods, products and utilities.
Data and data integrity are of the utmost importance within the life sciences sector to guarantee the patient’s safety, as well as the quality of pharmaceutical products and the integrity of your company data. Furthermore, data integrity strongly correlates with the reliability of your organization.
Data integrity refers to a variety of important processes to guarantee the completeness, accuracy, traceability and consistency of data during the total life cycle of the pertaining data. Naturally, this must all be in compliance with the current applicable legal requirements. It is of the utmost importance for each system saving, processing or recovering data.
Within the GxP environment, the submission of evidence in accordance with the laws and regulations is extremely important in order to prove the safety and efficacy of a product. For instance, in the event of legal disputes.
How can our Data Integrity experts help you?
Are you interested to examine and optimise data integrity within your organisation? Our data integrity experts have extensive experience in the field of audits, implementation and compliance of data integrity.
We would be pleased to assist you with data integrity assessments, the identification and collection of data, setting up and validating the data processes, audits and remediation & internal training.
Validation & qualification
Validation is the process by which it must be demonstrated in a documented manner and with a high degree of certainty that a predefined process consistently functions according to a specified use. With the help of tests and procedures, you will verify a system or process, and in this way demonstrate that it works again and again as expected and predetermined.
The V-model or the ASTM E2500 model with different phases and certain deliverables is used to perform validation correctly. With the latter model, the validation starts from the moment the design is drawn up. This is done by qualifying the design, the installation, the general functionality and the performance. After that, the process validation can start.
Within validation we define several subdomains:
- Equipment validation: validating e.g. a part of the production line.
- Process validation: the entire process must validated several times and the preset parameters are being monitored.
- Method validation: an analysis of the method is carried out in which it must be demonstrated that the method of analysis systematically performs the desired analysis so that the desired parameters are correctly analysed and the data is reliable.
- Lab equipment validation: the validation of lab equipments.
- Computer System Validation (CSV) validates automated systems and provides pharmaceutical manufacturers with the assurance that their computer-controlled processes and systems are operating consistently and in compliance with the applicable regulations.
- Validation of Water for Injection (WFI) systems or gases.
- Cleansing & Sterilization Validation (autoclaves, steam, EtO, irradiation,…): the validation that each component of the system is sterile after a given treatment using temperature mapping and/or biological indicators.
The validation, qualification and verification of established procedures & systems is an important part of the good manufacturing practices (GMP) and is imposed by governments and regulatory bodies such as the FDA, FAMHP, etc. A lot of attention is paid to this during an audit and insufficient validation can lead to critical observations, a negative audit or e.g. a production stop.