GMP consultancyIngelyt can perform in collaboration with the customer the whole GMP support for a new project. Likewise, the client may need to outsource any GMP task for which Ingelyt gives all the support and implementation of the entrusted tasks.

Ingelyt can give support in all these activities:

  • Conformance with the GMP regulation of facilities, personnel and plants processes
  • Audit of quality system of the plant in order to comply with regulatory requirements
  • Layouts review, personnel and material flows for a new project or adequacy of an existing zone
  • Compliance of products regulation with special requirements (beta-lactams, hormones, cytostatics, high-power, bio-based products) for new projects or areas
  • Performing protocols and execution of validation and cleaning of processes
  • Making Procedures (SOPs o PNTs) relating to a particular area or process
  • Performing the necessary documentation for the approval of a new area, project or facility (Technical report, Site master file, pharmaceutical plans, …) by a regulatory agency
  • Implementation and execution of Process Validation protocols, cleaning, sterilization, media fill for approving a zone project or sterile plant