Qualification is conducted parallel to all phases of the project, in accordance with the v-model as used in software development.

European-influenced companies often leads extensive design qualification and to that effect they need supplier specifications at an early stage of the projects.

Streamlined corporate structures, smaller project organizations and the lack of company-wide processes enables shorter decisions.

However, projects organised by mediumsized companies meets all necessary GMP-Requirements.

Project procedures are oriented toward five simple guidelines:

• Write down and allow an application whatever you plan. (Design)
• Check and document your design by an authorized procedure.(Design qualification)
• Record all plan changes and apply for authorisation. (Change Control)
• Record all installations and start-up by an authorized procedure.
  (FAT, Commissioning, SAT, Installation qualification)
• Check and document all critical system functions by authorized procedures. (Functional qualification)

Whoever delivers capital goods to the pharmaceutical industry should be well-versed in GMP-Requirements - within medium-sized firms as within large pharmaceutical companies.

Whatever your pharmaceutical customer needs, the project phases

• Technical clarification
• Clarification of pharmaceutical risks
• Detailed specifications
• Production documentation
• FAT, Commissioning and SAT

are significantly influenced by GMP-Regulations.

The more process understanding and GMP experience a supplier acquires, the better he protect themselves competitive advantages.

Qualification

Whatever you deliver to a pharmaceutical customer, your corresponding documentation e.g.

• Customized specifications
• Execution plans and
• Compilation- and commissioning activities

are significantly influenced by essential GMP-Compliance.

The more GMP-Profile a supplier acquires, the better he protect themselves competitive advantages.