1、 General European OMCL Network (GEON) QUALITY MANAGEMENT DOCUMENT PA/PH/OMCL (08) 73 R3 QUALIFICATION OF EQUIPMENT CORE DOCUMENT Full document title and reference Qualification of Equipment Core document PA/PH/OMCL (08) 73 R3 Document type Guideline Legislative basis Council Directive 2001/83/EC and
2、 2001/82/EC, as amended The present document was also accepted by EA as recommendation document to be used in the context of Quality Management System audits of OMCLs Date of first adoption 1stOctober 1999 Date of original entry into force 1stFebruary 2000 Date of entry into force of revised documen
3、t 1stMay 2017 Previous titles/other references / last valid version This document replaces document PA/PH/OMCL (08) 73 2R Custodian Organisation The present document was elaborated by the OMCL Network / EDQM of the Council of Europe Concerned Network GEON PA/PH/OMCL (08) 73 R3 Qualification of Equip
4、ment Core Document p. 2/8 QUALIFICATION OF EQUIPMENT CORE DOCUMENT Introduction The standard ISO/IEC 17025 requires an appropriate choice and qualification of equipment to be used for testing purposes. Particularly, checks and calibrations before and during use and, if needed, intermediate tests (se
5、e ISO/IEC 17025 chapter 5.5.10) are necessary. In order to guarantee a harmonized interpretation and application within the OMCL Network, the guideline Qualification of Equipment has been elaborated. From experience, the terms DQ, IQ, OQ and PQ (not explicitly mentioned by ISO/IEC 17025) have been u
6、sed in a non-harmonized way amongst the different OMCLs. Therefore their mention has been avoided in this document. This does not exclude their use in OMCLs quality systems where already approved and in application, or a reference to literature using this nomenclature. In order to simplify the manag
7、ement of the guideline, the present document contains only the general introduction and the first two levels of qualification, which are common to all type of equipment. The third and fourth levels of qualification can be found in separate instrument-related annexes. When considered appropriate, add
8、itional requirements and/or examples related to Level I and/or Level II have also been included in the annexes, which are to be used in combination with the general recommendations given in the core document. The list of annexes, included in this document, will be updated as soon as new annexes are
9、issued. This document should be considered as a guide to OMCLs for planning, performing and documenting the equipment qualification process. It should not be taken as an exhaustive list of compulsory tests. It is left to the professional judgement and background experience of each OMCL to decide on
10、the most relevant tests and the most appropriate tolerance limits for each of the parameters, in order to give evidence that the instrument is working properly and is appropriate for its intended use. If the qualification of equipment is done by the manufacturer itself or an external service, it is
11、under the responsibility of the OMCL to make sure that the checks performed are in line with the minimum requirements set in this guideline. To facilitate the implementation of a documented qualification process for the various analytical instruments, specific recommendations on minimum requirements
12、 are given in the corresponding annexes. For the more technique-related aspects of equipment qualification checks, practical examples of possible approaches are also presented in the annexes. The following four levels of Equipment Qualification should be considered by the OMCLs: PA/PH/OMCL (08) 73 R
13、3 Qualification of Equipment Core Document p. 3/8 Level I. Selection of instruments and suppliers The selection and purchase of new instruments shall follow a conscious decision process, based on the needs related to the intended use of the instrument. An example for setting and documenting such spe
14、cifications and decisions taken is given in Table I. Level II. Installation and release for use When receiving an instrument, the OMCL should check that it is received in good conditions, as ordered, and should monitor and document the installation process of the instrument in the selected environme
15、nt. This includes the start up checks done by the supplier, followed by a full periodic check as described in Level III. The release for use shall be documented and authorised by the person responsible for the instrument. An example for documenting the instrument installation and release for use and
16、 decisions taken is given in Table II. Level III. Periodic and motivated instrument checks When instruments are installed or moved into a new environment a series of checks have to be carried out to verify the key performance parameters of the instrument avoiding additional contributory effects from
17、 the analytical method. Depending on the frequency of use and the experienced stability of the instrument this shall be repeated periodically. The same verifications (or a relevant part of them) shall be carried out following events like significant repair or maintenance operations. Examples of para
18、meters to be checked on instruments and their typical acceptance limits can be found in the Table III of the corresponding instrument-related annex. The specifications from the manufacturer of the instrument should be taken into account when setting the tolerance limits. Some examples on how these c
19、hecks may be performed on each type of instrument are also provided in the corresponding Annexes. Level IV. In-use instrument checks During the day-to-day use of the instruments, checks are necessary to demonstrate continued evidence of satisfactory performance by the instrument itself and complianc
20、e with the system suitability criteria as defined in the applied analytical procedure for each product or group of products tested at this occasion. Examples of parameters to be checked on instruments and their typical acceptance limits can be found in the Table IV of the corresponding instrument-re
21、lated annex. In the case of OMCLs performing routine testing (batch release of vaccines and blood products), the use of control charts provides supplementary information on equipment performance, which can also be used in this context. PA/PH/OMCL (08) 73 R3 Qualification of Equipment Core Document p
22、. 4/8 List of instrument-related annexes The qualification levels dealt with in each annex are indicated in brackets. Annex 1: Qualification of HPLC equipment (Levels III and IV) Annex 2: Qualification of GC equipment (Levels III and IV) Annex 3: Qualification of UV-Visible spectrophotometers (Level
23、s I, III and IV) Annex 4: Qualification of IR spectrophotometers (Levels I, III and IV) Annex 5: Qualification of automatic titrators (Levels III and IV) Annex 6: Qualification of piston pipettes (Levels III and IV) Annex 7: Qualification of mass spectrometers (Levels III and IV) Annex 8 : Qualifica
24、tion of balances (Levels I to IV) Annex 9: Calibration/qualification of pH meters (Levels I to IV) Annex 10: Qualification of Atomic Absorption / Atomic Emission Spectrometers (Levels III and IV) PA/PH/OMCL (08) 73 R3 Qualification of Equipment Core Document p. 5/8 TABLE I Level I. Selection of inst
25、ruments and suppliers Example of check-list (non-exhaustive) Manufacturer: Provider/Distributor: Name of instrument and type: Attribute (This list may be adapted if necessary) Specifications Benefits (Instrument/supplier) Assessment Pass FailsTechnique Communication and data handling Interface RS232
26、 Data transfer to spread sheets Compatible with other hard- and software such as LIMS Safety Irradiation Explosion protection Documentation Manual (paper copy) Handling User language Service and maintenance Services offered Warranty Support Delivery (duration etc.) Installation (Service / Laboratory
27、) Training (in-house / external courses) PA/PH/OMCL (08) 73 R3 Qualification of Equipment Core Document p. 6/8 TABLE I (cont.) Requirements for media and environment Cost / Benefit Analysis Comments / Decisions Date / Signature: Date / Signature for approval: PA/PH/OMCL (08) 73 R3 Qualification of E
28、quipment Core Document p. 7/8 TABLE II Level II. Installation and release for use Example of check-list (non-exhaustive) Name of instrument and type: Identification code: Conformity with order (instrument / material / documentation) Pass Fails (description of deficiencies) Check of damages Pass Fail
29、s (description of deficiencies) Check of required media supply (connections / environmental conditions) Pass Fails (description of deficiencies) Installation of instrument(s) including possible control modules Pass Fails (description of deficiencies) Performance of start-up checks and diagnosis func
30、tions 1Pass Fails (description of deficiencies) 1if available Comments When appropriate, raw data are attached to the instrument documentation Date / Signature: Release and authorisation for use: Date / Signature: PA/PH/OMCL (08) 73 R3 Qualification of Equipment Core Document p. 8/8 Disclaimer: The
31、present Core Document of the OMCL Guideline “Qualification of Equipment”, as well as all its Annexes, have been drafted by ad-hoc working groups of technical experts, mainly coming from Official Medicines Control Laboratories (OMCLs) and only occasionally from other public institutions. These workin
32、g groups do not include any representative from any commercial organisation. This Core Document and its Annexes may contain trade names of laboratory instruments, materials and/or reagents. These are exclusively given as example in order to make these guidelines easier to understand and implement, a
33、nd were found to be suitable when the guideline was being developed. These references do not imply in any way that the mentioned instruments, materials or reagents or their suppliers are especially endorsed, recommended or certified by the EDQM, the OMCL Network or the Council of Europe, in preferen
34、ce to others of a similar nature which are not mentioned. It is therefore acceptable to use instruments, materials and reagents from another source, provided that they fulfil the necessary criteria laid down in these documents and appropriately satisfy the needs of the concerned laboratories in the frame of their specific activities.
