Qualification & Validation

“It is a GMP requirement that manufacturers control the critical aspects of their particular operations through qualification and validation over the life cycle of the product and process.” (EudraLex, Annex 15)

ALTEN supports its customers throughout the qualification and validation cycle in compliance with EUDRALEX Annex 15. Our engineers and pharmacists are experts in the V-cycle and ASTM E2500 validation methodologies.

ALTEN has also proven experience in delivering CSV projects for pharmaceutical companies and is fully qualified to meet clients’ requirements, complying with the applicable regulations (e.g. 21 CFR part 11).

ALTEN Belgium assists its customers in the following activities:
– Definition and implementation of validation/qualification methodologies. (VMP, VP, etc.)
– Planning and coordination of validation/qualification activities.
– Implementation of validation/qualification SOPs in Quality Management Systems.
– Designing (templates for) qualification and validation documentation. (Reports, protocols, etc.)
– Performing and managing equipment’s’ qualification, process validation and training of personnel. (IQ/OQ/PQ).
– Creating and running process validation groups.
– Promoting a scientific risk-based approach for a compliant validation and qualification program.

Our consultants provide support throughout the validation/qualification process in manufacturing & laboratory environment:

Equipment

• Filling lines, bulk, formulation areas
• Purification, (ultra) filtration
• Dry form equipment (tableting machine, powder mixer, granulation…)
• Laboratory instruments (chromatography, spectroscopy,…)
• Controlled storage (incubators, stability chambers, cold storage)
• Packaging and labelling

Process

• Product manufacturing
• Aseptic process
• Cleaning (CIP, machine, sinks)
• Sterilisation (autoclaves)
• Analytical methods

Utilities

• HVAC, Laminar Air flows
• WFI, PW
• ACP
CSV
• ERP (SAP, Microsoft Navision)
• LIMS
• Document Management Systems and other QMS applications (e.g.: Deviation, CAPA Systems, etc.)
• Manufacturing equipment
• Automation systems
• Laboratory Equipment
• Excel Spreadsheets