1. Key GMP Frameworks for International Markets

• US FDA 21 CFR Parts 210 & 211 for drugs entering the United States.
• EU GMP Guidelines governed by the European Medicines Agency for products in Europe.
• WHO GMP and other international standards (ICH Q7, Q8, Q9, Q10) for broader global recognition.

2. Typical Process for GMP Review & Certification of Filling Lines

• Define user requirements and regulatory scope

  • Establish a User Requirement Specification (URS) for the filling line (capacity, sterility level, container type, cleanroom class, automation, data integrity needs, etc.).
  • Map which GMP and technical standards apply (e.g., sterile manufacturing, cleanroom standards, pressure differentials, filtration, etc.).

• Design review and risk assessment

  • Confirm that equipment design is GMP‑compliant: hygienic design, cleanable and sterilizable surfaces, prevention of mix‑ups and cross‑contamination, appropriate material selection and drainability.
  • Conduct systematic quality and contamination risk assessments for critical steps such as washing, depyrogenation, filling, and sealing.

• Facility and utility qualification

  • Qualify cleanrooms, HVAC, water systems (e.g., Purified Water, WFI), compressed air, and other supporting utilities used by the filling line.
  • Demonstrate that environmental conditions support aseptic or controlled‑area filling (classified areas, differential pressures, temperature, humidity, and particulate/microbial controls).

• Equipment Qualification (DQ / IQ / OQ / PQ)
  GMP reviewers expect documented qualification of all critical equipment in the filling line, typically including:

  • Design Qualification (DQ) – Evidence that the filling machine and related systems are designed to meet URS and regulatory expectations.
  • Installation Qualification (IQ) – Proof that the line is installed correctly, according to design drawings, utility requirements, and safety standards.