Qualification & Validation

With decades of experience in pharmaceutical product manufacturing lifecycle services, as a subject matter expert (SME) we are offering a comprehensive variety of qualification and validation services that comply with US cGMP and EU GMP/PIC certifications.

Commissioning team is available at Pharmazone to help with any size of the project. With integrated commissioning and qualification (ICQ), good automated manufacturing practices (GAMP), continued process verification (CPV), pre-operational verifications, validation and verification (V&V), and processed analytical technology (PAT) capabilities, Pharmazone team can easily facilitate greenfield facility startup services and facility remediation services.

Qualification & Validation

With decades of experience in pharmaceutical product manufacturing lifecycle services, as a subject matter expert (SME) we are offering a comprehensive variety of qualification and validation services that comply with US cGMP and EU GMP/PIC certifications.

Commissioning team is available at Pharmazone to help with any size of the project. With integrated commissioning and qualification (ICQ), good automated manufacturing practices (GAMP), continued process verification (CPV), pre-operational verifications, validation and verification (V&V), and processed analytical technology (PAT) capabilities, Pharmazone team can easily facilitate greenfield facility startup services and facility remediation services.

With experience in project planning, specifications designing, risk assessments, commissioning, decommissioning, FATs, SATs, installation qualifications, operational qualifications, performance qualifications, summary reports, traceability matrixes, calibration, temperature and humidity mapping services, and more, we offer comprehensive solutions.

We offer services for GMP-compliant Commissioning & Qualification of all equipment, Utilities & facilities as well as Validation to ensure reproducible Processes for Production, Cleaning, Analytic Methods and Computer Systems.
Our Qualification Service includes complete lifecycle from project management to report writing that is from URS, FRS, DQ, FAT, SAT, Commissioning documents, VMP, IQ, OQ, PQ, to report writing.