What is a GMP Certification?
GMP is a system for ensuring that products/services are consistently produced and controlled according to
quality standards. Cleanrooms’ design & construction must be based on EN ISO 14644 and on the GMP’s guideline.
The basic principles and application of qualification and validation are described in Annex 15 to the PIC/S and EU Guide to GMP A GMP certification is assuring that the project meets all the criteria to be functional with the objective of providing the required quality level.
02. At a glance
Axis Medical, supplies and installs made to order (custom made) cleanroom modular wall system, according to your requirements and specifications combined with our architectural expertise, offering TURN - KEy engineering service & solutions.
Design qualification (DQ)
• The first element of the validation of new facilities, systems or equipment could be design qualification (DQ).
• The compliance of the design with GMP should be demonstrated and documented.
Installation qualification (IQ)
should be performed on new or modified facilities, systems and equipment.
• Verify Equipment and Material Meet Design Intent.
• Verify and/or Attend Factory Acceptance Testing.
• Verify Equipment and Material Installation Meet Industry Standard of Care.
• Verify Equipment Pre-Start Functions That Meet Manufacturer’s Requirements are Completed.
• Verify Equipment and System Start-up Meet Established Protocols.
• Verify Test and Balance Report.
• Assemble Operation and Maintenance Manuals.
Operational qualification (OQ) should follow Installation qualification.
OQ should include, but not be limited to the following:
(a) tests that have been developed from knowledge of processes, systems and equipment;
(b) tests to include a condition or a set of conditions encompassing upper and lower operating limits,
sometimes referred to as “worst case”
The Clean room Operational Verification
should be separated into its major
components, which are:
• Clean room Enclosure
• Process Equipment and Systems
• HEPA Filters
• HVAC Systems
• Performance qualification (PQ) should follow successful completion of Installation qualification
and Operational qualification.
• PQ should include, but not be limited to the following:
(a) tests, using production materials, qualified substitutes or simulated product,
that have been developed from knowledge of the process and the facilities,
systems or equipment;
(b) tests to include a condition or set of conditions encompassing upper and
lower operating limits.
• Although PQ is described as a separate activity, it may in some cases be appropriate to perform
it in conjunction with OQ.
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03. Sum up
Since we manufacture the system, we can produce fast and flexible solutions to meet planning challenges and diverse requirements, and achieve rapid implementation since everything originates from a single source.