Commissioning, Qualification and Validation
We have been providing Commissioning, Qualification, and Validation (CQV) services to our clients for over 18 years. Our dedicated CQV professionals bring a depth of knowledge across the entire validation lifecycle (VLC), having supported clients from all major sectors within the Life Sciences industry. We guide our clients in the selection of the right CQV strategy and fully support all deliverables, from protocol preparation, through “on the floor executions” data analysis and Report preparation.
Contact our specialists to tailor a service plan
CQV – Facilities /Utilities/ Equipment
Our CQV Team works with our clients to develop and implement their CQV strategy and offer various service delivery models which include:
- Full project model – we create High-Performance Teams (HPT) to deliver end-to-end solutions (e.g. from project management to the specific CQV deliverables, including creation of forecast and service demand tools, and KPI selection and monitoring).
- Staff augmentation model – we match your specific CQV need with any number of resources from our pool of CQV engineers and scientists, while staying connected with both our resources and clients to monitor progress and assure project success.
- Hybrid models – in the USA we have successfully engaged in hybrid models by inserting both high-performance teams (HPT) and specific resources within various workstreams of a larger project. We stay flexible from the beginning to the end of the project to build trust and create a true PharmaLex Partnership.
Tech Transfer/Process Validation/Cleaning Validation/Sterilisation
As per ICH Q10, we work with our clients “to transfer product and process knowledge between development and manufacturing, and within or between manufacturing sites to achieve product realisation. This knowledge forms the basis for the manufacturing process, control strategy, process validation approach and ongoing continual improvement.” (ICH Q10)
We offer global solutions covering the entire product lifecycle
Our solutions, consisting of core services, which are tailored to address each of your unique requirements. Extensive program management expertise is a key success factor within our service solutions.
Ensuring your internal systems, or those of your supplier or client meet the necessary requirements, is essential before undertaking any regulatory process. It is also pertinent to follow good practice (GxP) guidelines in order to satisfy the regulators that all aspects meet their standards.More Info
GxP Technical Consulting
Our GxP Technical Consulting Service provides access to our international Consulting Team, including a number of former EU and US Regulators, with expertise across the entire product lifecycle, ensuring that the broad Regulatory perspective is factored into the detailed consideration of your queryMore Info
Quality Systems and Compliance
PharmaLex can provide support with PQS planning, development and implementation. We can also remediate PQS that are not working properly and we can also provide support with the implementation or remediation of specific elements of the PQS such as Supplier management, Quality Risk Management, Change Management, Learning Management and deviation management to name a few. We can design and implement PQS for MIA, WDA and MAH.More Info
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