Description
Equipment qualification is a necessary and most important stage of quality assurance in the production of medicines. The Akademlab Independent Laboratory offers process validation and process equipment qualification services.
The main regulatory documents governing the qualification of equipment for GMP
Order of the Ministry of Industry and Trade of Russia of June 14, 2013 No. 916 "On Approval of the Rules of Good Manufacturing Practice (as amended by the Order of the Ministry of Industry and Trade of Russia of December 12, 2015 No. 4148)"
MU 64-04-001 "Production of medicines. Qualification. Basic provisions"
GOST R 52249 "Rules for the production and quality control of medicines"
GOST R 52537 "Production of medicines. Quality assurance system. General requirements"
The work on qualification and validation is carried out in accordance with the requirements of the GMP Rules established by Russian and international regulatory documents.
Equipment qualification stages
In accordance with the requirements of the GMP Rules and recommendations on the qualification of equipment in the production of medicines, it is necessary to conduct qualification at all stages:
Qualification of installation and installation of equipment (Installation Qualification - IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
We hold the qualification of the whole range of pharmaceutical manufacturing equipment.
The list of equipment and specific types of tests is constantly expanding. Our laboratory has extensive experience in qualifying the following groups of technological equipment:
Qualification of equipment for the production of sterile drugs
Aseptic filling, capping, seaming systems
Capacitive equipment (reactors, tanks, homogenizers, mixers)
Bottling lines
Lines of washing and depyrogenation
Sterilizers, sterilization tunnels and other sterilizing equipment
Lyophilic drying
Inspection Machines
Qualification of equipment for the production of non-sterile drugs
Tabletpress
Equipment for the production of aerosols and sprays
Bottling lines
Powder spraying
Mixers, granulators, homogenizers, dryers and other production equipment
Secondary packaging equipment qualification
Cartoning and labeling machines
Blister and other equipment for secondary packaging
Laboratory Equipment Qualification
Drying cabinets and dry heat sterilizers
Thermostats
Incubators
Laboratory sterilizers
Refrigerators, freezers
Chambers of cold (climatic chambers)
Insulators, laminar cabinets and biological protection cabinets
We are also ready to offer you qualification services for other types of equipment. If you need to qualify equipment that is not listed, contact us and we will prepare an offer for you.
Equipment qualification cost
The cost of equipment qualification depends on many factors: the specific type of equipment, the required qualification stages, the specifics of the technological process, the number and duration of equipment operation modes in which qualification is required, as well as the total validation work.
Benefits of an independent lab
Attracting an independent laboratory to work on the qualification of equipment not only simplifies life and saves time for employees of the company's own quality assurance service, but also provides a number of additional benefits:
The protocols of the independent laboratory inspire confidence among the experts, so you will easily and without any questions pass the inspection control.
In case of discrepancies in the process of qualification of equipment, the laboratory specialists will immediately inform the responsible person at the enterprise.
Our experts will advise on the elimination of non-compliances.
If the detected non-compliances are eliminated promptly, we will repeat the tests free of charge, and you will not have to spend money on re-conducting the whole complex of equipment qualification works.
When re-conducting qualifications in our laboratory (re-qualification), the time for preparing reporting documentation and the cost of work are significantly reduced.
