 | An assembly system for the manufacture of medical devices must not only meet the demands of the customer, but also satisfy specific safety and contractual requirements. It is obvious that products which administer medication for inhalation or injection must demonstrate an absolute level of safety both for the user and for the medication.
GAMP guidelines.
GAMP (Good Automated Manufacturing Practice) guidelines were established for users and suppliers of automatic machines and assembly systems.
This allows the pharmaceutical company to define a standard of manufacture and documentation for medical product manufacturing systems which should be followed to achieve FDA validation for the production systems. The customer must demonstrate that an assembly system functions correctly in accordance with the specifications and that the product – when in production – has the quality demanded. Production release is achieved via a qualification process comprising the following four phases:
1) Design Qualification (DQ)
Assembly machine description.
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2) Installation Qualification (IQ)
Check installed integrated systems for compliance with design requirements.
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3) Operational Qualification (OQ)
Check machine’s main and critical functions and calibration documents.
Check machine efficiency (FAT, SAT).
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4) Process Qualification (PQ)
Establishes evidence that the equipment manufactures products meeting final device specifications in a production environment. |
Project management – successful qualification methods
The entire Mikron qualification support system is standardized and integrated in the project management procedure.
The basic machine
The requirements of the American Food and Drug Administration (FDA) have been taken into account in the design of the assembly system. The design of the system has a clear division, with the working and assembly operations carried out at the front of the cell and a maintenance area at the rear. This allows the machine to be operated simply and safely. The platform and structure are manufactured as standard from stainless steel, ensuring cleanliness, long life and compliance with the demands of a class 10,000 clean room environment.
The control system is also designed to minimize specialist programming; as a result the machine is highly functional, easy to use. Core PC software is also validated.
21 CFR Part 11
Mikron helps our customers meet the requirements of 21 CFR Part 11
What Mikron delivers to their customers
package including documentation needed, the performance of qualification tasks through the complete machine/system development life cycle in accordance with FDA - GMP requirements and GAMP 4 guidelines and support of our customers in their validation process.
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