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Commissioning – Certification

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01. Intro

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”

conditions.

The Clean room Operational Verification

should be separated into its major

components, which are:

• Clean room Enclosure

• Lighting/Electrical

• Noise

• Process Equipment and Systems

• HEPA Filters

• HVAC Systems

• Vibration

Performance qualification

• 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.

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.