Unfortunately, validation is not seen as a value-adding execise by management. It consumes enormous person-hours and requires specific expertise.
PharmOut supplies experienced Validation Consultants and/or Validation Contractors to support you through your validation projects. They will use a risk-based approach to validate only what needs to be validated to ensure product quality.
If you need help with determining what to validate, when and how to do it, or perhaps a review of your current validation, our Validation Consultants will use a risk based approach to develop a validation master plan and practical tips to meet your needs. More
If you just need experienced validation professionals to do the time consuming task of developing validation protocols and doing the testing then PharmOut can supply validation contractors to do just that. More
Process validation according to the most recent regulations. More
Equipment validation to international regulatory standards and in accordance with current Good Manufacturing Practice. More
Validation of computer systems using GAMP 5 methodologies. More
Cleaning validation for pharmaceutical, complementary medicines and other biological manufacturing facilities. More
Validation is a regulatory compliance requirement that means a GMP-facility must collect and document scientific evidence to prove that the process, materials, equipment and computer systems produce products of consistent quality.