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 Commissioning Qualification and Validation Consultancy (CQV) who specialise in the support of their clients' development and manufacture of pharmaceutical products. We can assist clients in ensuring 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 ensure sign off.
GMPG are aware that the cost and planning of the CQV activies are critical to the outcome of any project. We have therefore put into use planning, cost control and monitoring procedures to ensure the client has full visibility of our works.
Validation activities that can be undertaken include:
Facilities, Utilities,& Equipment (FUE) Qualification & Validation
Computer System Validation
Design qualification and GMP reviews
Process Validation
Cleaning Validation
Laboratory Validation (Including Analytical Methods)
Thermal Mapping.
Factory and Site Acceptance Testing
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.
To speak with us further about this or to arrange a meeting, please contact us:
ISO-9001
Cert no. 11289
ISO-14001
Cert no. 11289
ISO-45001
Cert no. 11289