Services

QP Inspection

ServicesGlobal ComplianceQP Inspection

QP (Qualified Person) inspection means the comprehensive compliance inspection conducted by a qualified QP for evaluating the company’s compliance level comprehensively according to the inspection result as well as the rectification of identified questions. The enterprise that passes QP inspection will be issued a compliance declaration, which is not only a strong proof of the company’s compliance with international GMP requirements but also a precondition for products to enter the international market.

At present, EU QP is the most representative and persuasive audit inspection due to its strict qualification requirements. We have senior EU QP consultants in different fields to support the development of our customers’ international market, such as biological pharma, sterile products, oral solid products, ADC (Antibody-Drug Conjugates products), ATMP (Advanced Therapy Medicinal Products), CGT (Cellular and Gene Therapy Products), blood products, high potency products, API, etc.


Service Workflow:

Service Advantage

gempex has an influential and professional QP qualified team, and our compliance declaration is highly recognized in this industry.
gempex QP qualification covers various products, such as biological pharma, sterile products, oral solid products, ADC, ATMP, CGT, blood products, high potency products, API, etc.
gempex experts are familiar with the process and requirements of QP inspection, and are capable of providing guidance for customers to undergo QP inspection.
gempex experts have implemented multiple inspections as QP representatives, and have been qualified as QP.
advantage

The QP Inspection Service Includes but Not Limited to

  • QP gap analysis, assisting customers to meet the inspection requirements by identifying problems in advance and providing rectification guidance.
  • QP mock inspection, supporting customers in becoming familiar with the inspection process by drilling prior to inspection.
  • Inspection support, onsite inspection support or translation.
  • QP inspection, issuing inspection report and compliance declaration.