The International Regulatory bodies (FDA, EMA, WHO) currently require that all systems and processes relating to the manufacture of a pharmaceutical product be validated before a facility inspection is made. Evidence of validation is therefore required in documented form.
The GMP Group is a Technology and Validation Consultancy who specialise in the support of their clients developing and manufacturing pharmaceutical products. We can assist clients to ensure that the introduction of processes and process equipment is undertaken efficiently and effectively and in such a manner that it can be fully validated in accordance with regulatory requirements.
The GMP Group have experience in the presentation of documents to the relevant regulatory authorities and can ensure that documents not only contain the relevant information, but also have been prepared against a standard operating procedure, which will include signing off.
Validation activities that can be undertaken include Validation Master Planning, Design Qualification and GMP Reviews, Installation/Operational/Performance Qualification, Process Validation, Factory and Site Acceptance test witnessing, plus much more.
To speak with us further about this. or to arrange a meeting, please call us on 08450 344 340 or click below to send us an email