World Health Organization

World Health Organization
19 April, 2017 Supplementary Training Modules on Good Manufacturing Practice Good Practices for Quality Control Laboratories Part 1: Introduction, management and infrastructure This Module consists of 4 parts: Part 1: Management and organization Part 2: Materials, equipment, instruments and devices Part 3: Working procedures and documents, and safety in the laboratory Part 4: Inspecting the laboratory WHO Technical Report Series, No. 902, Annex 3

Quality Control 19 April, 2017 Objectives To discuss Good Practices for Quality Control laboratories including quality systems and infrastructure To understand the role and importance of the Quality Control laboratory in: sampling and testing materials, equipment and systems To discuss approaches in inspecting a Quality Control laboratory Objectives To discuss Good Practices for Quality Control laboratories including quality systems and infrastructure To understand the role and importance of the Quality Control laboratory in: Sampling and testing Materials, equipment and systems To discuss approaches in inspecting a Quality Control laboratory Part One.

Quality Control 19 April, 2017 Introduction This Module consists of four parts: Part 1: Management and organization Part 2: Materials, equipment, instruments and devices Part 3: Working procedures and documents, and safety in the laboratory Part 4: Inspecting the laboratory Part One.

Quality Control 19 April, 2017 Introduction (2) Many of the recommendations relevant to quality control testing at the site of the pharmaceutical manufacturer The QC laboratory provides a service and is like a manufacturing unit – its “products” include test results, advice and investigations Needs buildings, personnel, resources equipment, raw materials quality assurance programme Part One.

Quality Control 19 April, 2017 In Part 1: Management and infrastructure: Organization and management Quality systems Control of documentation and records Data processing equipment Personnel Premises, equipment, instruments and other devices Part One.

Quality Control 19 April, 2017 1. Organization and management: Function in accordance with national legislation Operate in accordance with the guideline WHO Technical Report Series, No. 902, 2002, Annex 3 See also general texts on Good Manufacturing Practices and Good Practices in Quality control WHO Technical Report Series, No. 908, 2003, Annex 4 Part One. Management and infrastructure 1. Organization and management 1.1 The laboratory or the organization of which it is part must be an entity that is legally authorized to function and can be held legally responsible. 1.2 The laboratory must be organized and operate so as to meet the requirements laid down in this guideline. Part One 1.1– 1.2

Quality Control 19 April, 2017 1. Organization and management (2): Personnel Managerial and technical positions to ensure operation in accordance with quality systems No conflict of interest Organizational chart and job descriptions Supervision and training 1.3 The laboratory must (a) have managerial and technical personnel with the authority and resources needed to carry out their duties and to identify the occurrence of departures from the quality system or the procedures for performing tests and/or calibrations, validation and verification, and to initiate actions to prevent or minimize such departures; (b) have arrangements to ensure that its management and personnel are commercial, political, financial and other pressures or conflict of interest that may adversely affect the quality of their work; (c) define, with the aid of organizational charts, the organization and management structure of the laboratory, its place in any parent organization such as the ministry or the drug regulatory authority, and the relationships between management, technical operations, support services and the quality system; (d) specify the responsibility, authority and inter-relationships of all personnel who manage, perform or verify the work which affects the quality of the tests and/or calibrations, validations and verifications; (e) provide adequate supervision of staff, including trainees, by persons familiar with the test and/or calibration, validation and verification methods and procedures, as well as their purpose and the assessment of the results; (f) have a technical manager, which has overall responsibility for the technical operations, and the provision of resources needed to ensure the required quality of laboratory operations; and (g) have appropriate safety procedures (see Part Four). Part One. 1.3

Quality Control 19 April, 2017 1. Organization and management (3): Large laboratories may have subunits A central registry responsible for: receipt and distribution of samples keeping records and documents of incoming samples allocation of work and responsibilities maintaining specifications "up to date" (specifications "archive") 1.3 The laboratory must (a) have managerial and technical personnel with the authority and resources needed to carry out their duties and to identify the occurrence of departures from the quality system or the procedures for performing tests and/or calibrations, validation and verification, and to initiate actions to prevent or minimize such departures; (b) have arrangements to ensure that its management and personnel are commercial, political, financial and other pressures or conflict of interest that may adversely affect the quality of their work; (c) define, with the aid of organizational charts, the organization and management structure of the laboratory, its place in any parent organization such as the ministry or the drug regulatory authority, and the relationships between management, technical operations, support services and the quality system; (d) specify the responsibility, authority and inter-relationships of all personnel who manage, perform or verify the work which affects the quality of the tests and/or calibrations, validations and verifications; (e) provide adequate supervision of staff, including trainees, by persons familiar with the test and/or calibration, validation and verification methods and procedures, as well as their purpose and the assessment of the results; (f) have a technical manager, which has overall responsibility for the technical operations, and the provision of resources needed to ensure the required quality of laboratory operations; and (g) have appropriate safety procedures (see Part Four). Part One. 1.4

Quality Control 19 April, 2017 2. Quality system: Management to establish, implement and maintain quality system It should cover policies, systems, programmes, procedures and instructions Communicated, available, understood and implemented Documented in a quality manual available to the laboratory personnel maintained and updated by a responsible person 2. Quality system 2.1 The laboratory management establishes, implements and maintains a quality system appropriate to the scope of its activities, including the type, range and volume of testing and/or calibration, validation and verification activities it undertakes. The laboratory management describes its policies, systems, programmes, procedures and instructions to the extent necessary to enable the laboratory to assure the quality of the test results it generates. Documentation used in this quality system must be communicated and available to, understood and implemented by, the appropriate personnel. The elements of this system must be documented in a quality manual, which is available to the laboratory personnel and must be maintained and updated by a nominated responsible member of the laboratory personnel. The quality manual must contain at minimum: (a) the structure of the laboratory (organizational chart); (b) the operational and functional activities pertaining to quality, so that each person concerned will know the extent and the limits of responsibilities; (c) general internal quality assurance procedures; (d) reference to specific quality assurance procedures for each test; (e) participation in appropriate proficiency testing schemes, use of reference materials. etc.; (f) satisfactory arrangements for feedback and corrective action when testing discrepancies are detected; (g) procedure for dealing with complaints; (h) a flow chart for samples; (i) details of audit and quality system review; (j) appropriate qualification of personnel; (k) training and maintaining competence of staff; and (l) a quality policy statement, including at least the following: i. a statement of the laboratory management's intentions with respect to the standard of service it will provide ii. the purpose of the quality system iii. the laboratory management's commitment to good professional practice and quality of testing, calibration, validation and verification, as a service to its clients iv. the laboratory management's commitment to compliance with the content of this guideline v. a requirement that all personnel concerned with testing and calibration activities within the laboratory familiarize themselves with the documentation concerning quality, implementation of the policies and procedures in their work. Part One. 2.1

Quality Control 19 April, 2017 The quality manual should contain at least: Organizational chart; operational and functional activities General and specific quality assurance procedures Proficiency testing schemes Use of reference materials Feedback and corrective action (for testing discrepancies) Part One. 2.1

Quality Control 19 April, 2017 The quality manual should contain at least (continued): Procedure for dealing with complaints A flow chart for samples Details of audit and quality system review Qualification of personnel Training and maintaining competence of staff A quality policy statement Part One. 2.1

Quality Control 19 April, 2017 The quality policy statement should include at least: A statement of the standard of service it will provide The purpose of the quality system Management's commitment to: Good professional practice and quality of testing, calibration, validation and verification, as a service to its clients Compliance with Good Practices All personnel to familiarize themselves with the documentation concerning quality, implementation of the policies and procedures Part One. 2.1

Quality Control 19 April, 2017 The quality system must be reviewed systematically and periodically e.g. internal and external audits with reports and details of any corrective action taken Laboratory quality manager appointed with: defined responsibilities and authority for ensuring that the quality system is implemented and followed at all times direct access to the highest level of management at which decisions are taken on laboratory policies or resources 2.2 The quality system must be reviewed systematically and periodically (internal and external audits) by, or on behalf of, , the management to ensure continued effectiveness of the arrangements, and apply any necessary corrective measures. Such reviews must be recorded together with details of any corrective action taken. 2.3 The laboratory management must appoint a member of the staff as quality manager, who, irrespective of other duties and responsibilities, should have defined responsibilities and authority for ensuring that the quality system is implemented and followed at all times. The quality manager must have direct access to the highest level of management at which decisions are taken on laboratory policies or resources. Part One

Quality Control 19 April, 2017 3. Control of documents Documentation is essential Procedures to control and review all documents The laboratory must establish and maintain procedures for identification, collection, indexing, access, storage, maintenance and disposal of quality documentation and technical records 3. Control of documentation 3.1 Documentation is an essential part of the quality system. The laboratory must establish and maintain procedures to control and review all documents (internally generated and from external sources) that form part of the quality documentation. Part One. 3.1

Quality Control 19 April, 2017 4. Records All original observations, calculations and derived data, calibration, validation and verification records, etc. and final results must be retained on record for an appropriate period of time, e.g. whole length of time the drug is on the market Records to contain sufficient information to permit repetition of tests and include, e.g.: identity of the personnel involved in sampling, preparation and testing of the samples Instruments, equipment, etc. 4. Records 4.1 The laboratory must establish and maintain procedures for identification, collection, indexing, access, storage, maintenance and disposal of quality documentation and technical records. 4.2 All original observations, calculations and derived data, calibration, validation and verification records etc. and final results must be retained on record for an appropriate period of time in accordance to national regulations. Ideally, they should be kept for the whole length of time the drug is on the market. The records for each test must contain sufficient information to permit repetition of tests. The records must include the identity of the personnel involved in sampling, preparation and testing of the samples. The records of samples for legal proceedings should be kept according to legal requirements. Part One. 4.1 – 4.2

Quality Control 19 April, 2017 Records must be: Legible and readily retrievable Stored and retained in a manner that prevents modification, damage or deterioration and/or loss Held secure and in confidence Includes reports from internal audits and management reviews and records from possible corrective and preventive actions 4.3 All records must be legible, readily retrievable, stored and retained, using facilities that provide a suitable environment to prevent modification, damage or deterioration and/or loss. All original records must be held secure and in confidence. Quality records must include reports from internal audits and management reviews including records from possible corrective and preventive actions. Part One. 4.3

Quality Control 19 April, 2017 SOPs: written and authorized For administrative and technical operations, such as: Purchase and receipt of consignment of materials e.g. samples, reference material, reagents Internal labelling, quarantine and storage of materials Appropriate installation of each instrument and equipment Sampling and inspection Testing materials, describing the methods and equipment used 4.4 Standard operating procedure (SOP). Authorized written procedures are required, but not limited to, giving instructions for administrative and technical operations, such as: (a) purchase and receipt of consignment of materials (e.g. samples, reference material, reagents) (b) internal labelling, quarantine, and storage of materials (c) appropriate installation of each instrument and equipment (d) sampling and inspection (e) testing materials, describing the methods and equipment used (f) equipment qualification (g) analytical apparatus and calibration (h) maintenance, cleaning, sanitation (i) safety measures (j) personnel matters including qualification, training, clothing, and hygiene (k) environmental monitoring (l) preparation and control of reference materials. Part One. 4.4

Quality Control 19 April, 2017 Other SOPs: Qualification, analytical apparatus Calibration, maintenance, cleaning, sanitation Safety measures Personnel matters including qualification, training, clothing, and hygiene Environmental monitoring Preparation and control of reference materials Part One. 4.4

Quality Control 19 April, 2017 5. Data processing equipment Includes computers, automated tests or calibration equipment; used for collection, processing, recording, reporting, storage or retrieval of test and/or calibration data Where used, requires systematic verifications of calculations and data transfers For computer software developed by the user: this documented in detail validated or verified as being adequate for use 5. Data processing equipment 5.1 For computers, automated tests or calibration equipment the collection, processing, recording, reporting, storage or retrieval of test- and/or calibration-data, the laboratory must ensure that: (a) calculations and data transfers be subject to appropriate verifications in a systematic manner; (b) computer software developed by the user is documented in sufficient detail and suitably validated or verified as being adequate for use; (c) procedures are established and implemented for protecting the integrity of data. Such procedures must include, but are not limited to, integrity and confidentiality of data entry or collection, their storage, transmission and processing; (d) computers and automated equipment are maintained to function properly. They are provided with environmental and operating conditions necessary to ensure integrity of test- and calibration-data; (e) procedures are established to describe how changes are made, documented, and controlled for information maintained in computerized systems; and (f) procedures exist to protect and keep back-up data on computers or other means at all times, and prevents unauthorized access or amendments to the data. Part One. 5.1

Quality Control 19 April, 2017 5. Data processing equipment Located in suitable environmental supporting operating conditions Maintenance of computers and automated equipment Procedures established and implemented for protecting data integrity Include, e.g. integrity and confidentiality of data entry or collection, data storage, transmission and processing Procedures in place to describe how: Changes are made, documented and controlled for information maintained To protect and keep back-up data at all times To prevent unauthorized access or amendments to the data 5. Data processing equipment 5.1 For computers, automated tests or calibration equipment the collection, processing, recording, reporting, storage or retrieval of test- and/or calibration-data, the laboratory must ensure that: (a) calculations and data transfers be subject to appropriate verifications in a systematic manner; (b) computer software developed by the user is documented in sufficient detail and suitably validated or verified as being adequate for use; (c) procedures are established and implemented for protecting the integrity of data. Such procedures must include, but are not limited to, integrity and confidentiality of data entry or collection, their storage, transmission and processing; (d) computers and automated equipment are maintained to function properly. They are provided with environmental and operating conditions necessary to ensure integrity of test- and calibration-data; (e) procedures are established to describe how changes are made, documented, and controlled for information maintained in computerized systems; and (f) procedures exist to protect and keep back-up data on computers or other means at all times, and prevents unauthorized access or amendments to the data. Part One. 5.1

Quality Control 19 April, 2017 6. Personnel Sufficient number, with necessary education, training, technical knowledge and experience No conflict of interest or other pressure Competence ensured for activities, performing tests and/or calibrations, validations or verifications, evaluation of results and signing test reports and calibration certificates Staff undergoing training – supervised, with formal assessment after training Personnel must be qualified on the basis of appropriate education, training, experience and/or demonstrated skills 6. Personnel 6.1 The laboratory must have sufficient personnel with the necessary education, training, technical knowledge and experience for their assigned function. The personnel should be free from any conflict of interest and pressure that will interfere with the quality of the results. 6.2 The laboratory management must ensure the competence of all persons operating specific equipment, instruments or other devices, who are performing tests and/or calibrations, validations or verifications. Their duties also involve the evaluation of results as well as signing test reports (Appendix 1) and calibration certificates. 6.3 Staff undergoing training must be appropriately supervised, and a formal assessment after training is recommended. Personnel performing specific tasks must be qualified on the basis of appropriate education, training, experience and/or demonstrated skills, as required. Part One. 6.1 – 6.3

Quality Control 19 April, 2017 6. Personnel (2) Permanently employed, or under contract Contracted personnel to be supervised and sufficiently competent, motivated – work complying good practice of the laboratory Current job descriptions for managerial, technical and key support personnel Records of competence, educational and professional qualifications, training, skills and experience Readily available, and include date of confirmation of competence, plus criteria for confirmation and name of the confirming authority 6.4 The laboratory must use permanently employed personnel, or who are under contract. The laboratory must ensure that contracted, additional technical and key support personnel are supervised and sufficiently competent, motivated, and that their work is in accordance with the good practice of the laboratory. 6.5 The laboratory must maintain current job descriptions for managerial, technical and key support personnel involved in tests and/or calibrations, validations and verifications. Part One. 6.4 – 6.5

Quality Control 19 April, 2017 Managerial and technical personnel: Head of laboratory (supervisor) Head of central registry Analysts Technical staff Head of central store Quality Manager 6.5.1 The laboratory must maintain records of all technical personnel, contracted personnel included, concerning the relevant competence, educational and professional qualifications, training, skills and experience. This information must be readily available and must include the date on which authorization and/or competence has been confirmed. The criteria on which the authorization is based must also be given and the name of the confirming authority. 6.6 The laboratory must have the following managerial and technical personnel: 6.6.1 Head of laboratory (supervisor) The person must be of high professional standing with extensive experience in drug analysis and laboratory management in a pharmaceutical control laboratory in the regulatory sector or in the industry. The person’s function is to ensure that (a) all key members of the laboratory staff have the requisite competence and are given levels of grades matching their responsibilities (b) standard samples are analysed periodically (c) the adequacy of existing staffing, management, and training procedures is reviewed periodically (d) "self-checking" procedures for instrument operators are devised (e) regular in-service training programmes to update and extend the skills of both professionals and technicians are arranged (f) the safe-keeping of any narcotics (see Part One ) kept in the workplace is under the supervision of an authorized person (g) ultimate responsibility for recommending any regulatory action in the event of non-compliance of a tested sample is taken. Part One. 6.6

Quality Control 19 April, 2017 Head of laboratory (supervisor) should have extensive experience in drug analysis and laboratory management. Functions include: All key staff have the requisite competence Standard samples are analysed Periodic review of adequacy of existing staffing, management, and training procedures "Self-checking" procedures for instrument operators are devised Regular in-service training programmes are arranged Safe-keeping of any narcotics as where relevant 6.6.1 Head of laboratory (supervisor) The person must be of high professional standing with extensive experience in drug analysis and laboratory management in a pharmaceutical control laboratory in the regulatory sector or in the industry. The person’s function is to ensure that (a) all key members of the laboratory staff have the requisite competence and are given levels of grades matching their responsibilities (b) standard samples are analysed periodically (c) the adequacy of existing staffing, management, and training procedures is reviewed periodically (d) "self-checking" procedures for instrument operators are devised (e) regular in-service training programmes to update and extend the skills of both professionals and technicians are arranged (f) the safe-keeping of any narcotics (see Part One ) kept in the workplace is under the supervision of an authorized person (g) ultimate responsibility for recommending any regulatory action in the event of non-compliance of a tested sample is taken. Part One

Quality Control 19 April, 2017 Head of central registry functions include: Receiving and keeping records of all incoming samples and accompanying documents Supervising their consignment to the specific units Monitoring the progress of analyses and dispatch of completed reports (see also Part One,1.4) May collate and evaluate the test results for each analysis 6.6.2 Head of central registry The person must have a wide experience in drug analysis and be responsible for (a) receiving and keeping records of all incoming samples and accompanying documents (b) supervising their consignment to the specific units (c) monitoring the progress of analyses and despatch of completed reports (see also Part One. 1.4). The person may also be required to collate and evaluate the test results for each analysis. Part One

Quality Control 19 April, 2017 Analysts and technical staff: Graduates or diplomas in pharmacy, analytical chemistry, microbiology, or other relevant subjects Knowledge, skills and ability to adequately perform the tasks Store keeper: Keeping the central store – competent and trained to handle reagents and materials with the necessary care and safety. Quality manager (see Part One, 2.3) 6.6.3 Analysts. The persons must be graduates in pharmacy, analytical chemistry, microbiology, or other relevant subjects with the requisite knowledge, skills and ability to adequately perform the tasks that their management assigned them and to supervise technical staff. 6.6.4 Technical staff. The technicians should hold diplomas in their subjects from technical or vocational schools. 6.6.5 Store keeper (see Part Two ). The person is responsible for keeping the central store and must have appropriate competence and be trained to handle reagents and materials with the necessary care and safety. 6.6.6 Quality manager (see Part One. 2.3) 6.7 In large laboratories with subunits, the following additional personnel is necessary: 6.7.1 Heads of various subunits 6.7.2 Reference material coordinator (see Part Two ) Part One – 6.7.2

Quality Control 19 April, 2017 Other staff members can be: Heads of various subunits Reference material coordinator (see Part Two,11.3.2) Ratio of personnel: In general technicians to analysts in a routine testing environment has been shown to be 3:1 in a chemical or physicochemical unit and 5:2 in a biological or microbiological laboratory 6.8 Ratio of personnel. The more routine analyses are performed, the greater the proportion of technicians are effectively employed. Non-routine work, and particularly the review of test methods for newly registered drugs, requires a higher proportion of fully qualified specialists. In general, the ratio of technicians to analysts in a routine testing environment has been shown to be 3:1 in a chemical or physicochemical unit, and 5:2 in a biological or microbiological laboratory. Part One. 6.7 – 6.8

Quality Control 19 April, 2017 7. Premises Suitable size, construction and location – safety requirements considered in the design Adequate degree of separation of the activities Sufficient number of rooms or areas to assure the isolation of test systems Suitable testing and safety equipment e.g. voltage stabilizers should be installed where needed Storage rooms or areas for supplies and materials with protection against infestation, contamination, and/or deterioration 7. Premises 7.1 The laboratory should be of a suitable size, construction and location. Safety requirements should be taken into the design consideration (see Part Four). 7.2 The design of the laboratory should provide an adequate degree of separation of the activities, which may interfere with the proper conduct of each study. 7.3 The laboratory should have a sufficient number of rooms or areas to assure the isolation of test systems. 7.4 The premises must have suitable testing and safety equipment. For example, the needed energy sources and where the line voltage is variable, suitable voltage stabilizers should be installed. 7.5 Storage rooms or areas should be available as needed for supplies and materials and should be conveniently located. These rooms should be separated from those areas housing the test systems and should provide adequate protection against infestation, contamination, and/or deterioration. Part One. 7.1 – 7.5

Quality Control 19 April, 2017 7. Premises (2) Separate areas for receipt, storage and sample preparation to prevent contamination or mix-ups Ensure maintaining identity, concentration, purity, and stability Safe storage of hazardous substances Fire regulations Flammable reagents, fuming and concentrated acids, bases, volatile amines – safe storage separately 7.6 To prevent contamination or mix-ups, separate rooms or areas for receipt and storage of test and reference items should be available, as well as for the mixing of test items with a vehicle. 7.7 Storage rooms or areas for test items should be separate from rooms or areas containing the test systems. They should be built adequately to preserve identity, concentration, purity, and stability, and ensure safe storage of hazardous substances. All storage areas must be located and equipped in accordance with fire regulations. For safety reasons and to reduce contamination of the laboratory environment, storage of flammable reagents, fuming and concentrated acids, bases, volatile amines and others must never be kept in the laboratory without good reasons. Part One. 7.6 – 7.7

Quality Control 19 April, 2017 Central store Separate for secure storage of samples, retained samples, reagents, laboratory accessories, reference materials Appropriate storage conditions, e.g. refrigeration where necessary Restricted access to designated personnel Organized to accommodate incoming and outgoing samples, reagents, equipment, instruments and other devices 7.7.1 Central store Separate central storage facilities must be maintained for the secure storage of samples, retained samples (see Part Three. 18), and reagents, laboratory accessories (see Part Two. 10.7) and reference materials (see Part Two. 11). Storage facilities must provide the possibility to store material, if necessary, under refrigeration and securely locked-up. Access to be restricted to designated personnel. The central store should be organized in such a way to accommodate incoming and outgoing samples, reagents, equipment, instruments and other devices. Appropriate safety regulations must be drawn up and rigorously implemented wherever toxic or flammable reagents are stored or used. Reagents subject to poison regulations or to the controls applied for narcotic and psychotropic substances must be clearly marked as "Poison". They must be kept separately from other reagents in locked cabinets. Part One –

Quality Control 19 April, 2017 Central store (2) Safety instructions if toxic or flammable reagents are stored or used Poison, narcotic and psychotropic substances marked as "Poison", kept separately, in locked cabinets register maintained Archive facilities documents, samples and specimens conditions to protect from deterioration, and access restricted Handling and disposal of wastes facilities for collection, storage and disposal decontamination, where applicable, and transportation The designated responsible member of staff must maintain a register of these substances. The head of each unit must accept personal responsibility for the safekeeping of any of these reagents kept in the workplace (see Part One ). 7.8 Archive facilities should be provided for the secure storage and retrieval of all documents (internally generated or from external sources), samples of test items and specimens. Archive design and archive conditions should protect contents from untimely deterioration. Access to be restricted to designated personnel. 7.9 Handling and disposal of wastes should be carried out as not to jeopardize the integrity of studies and environment. Provision of appropriate facilities for collection, storage and disposal should be available, as well as means of decontamination, where applicable, and transportation. 7.10 The environment in which the tests are undertaken must not invalidate the test results or adversely affect the required accuracy of measurements. This particularly applies to sites other than the permanent laboratory premises. Testing premises must be protected as required from excessive conditions, such as heat, cold, dust, moisture, steam, noise, vibration and electromagnetic disturbance or interference. Devices to monitor the environmental conditions must be installed if required by the nature of testing. Access to and use of all test areas must be controlled and limited to their designated purpose. For persons external to the laboratory the conditions of entry must be defined. Adequate measures must be taken to ensure good housekeeping in the test laboratory. Part One – 7.10

Quality Control 19 April, 2017 Central store (3) Laboratory environment suitable and not influence the tests Protected from excessive conditions, e.g. heat, cold, dust, moisture, steam, noise, vibration and electromagnetic disturbance or interference Monitoring devices for environmental conditions Good housekeeping 7.10 The environment in which the tests are undertaken must not invalidate the test results or adversely affect the required accuracy of measurements. This particularly applies to sites other than the permanent laboratory premises. Testing premises must be protected as required from excessive conditions, such as heat, cold, dust, moisture, steam, noise, vibration and electromagnetic disturbance or interference. Devices to monitor the environmental conditions must be installed if required by the nature of testing. Access to and use of all test areas must be controlled and limited to their designated purpose. For persons external to the laboratory the conditions of entry must be defined. Adequate measures must be taken to ensure good housekeeping in the test laboratory. Part One. 7.10

Quality Control 19 April, 2017 8. Equipment, instruments and other devices Designed, constructed, adapted, located, calibrated, qualified, verified and maintained Purchased from approved suppliers – can give technical support, maintenance Documentation in the language employed in the laboratory Appropriate test equipment, instruments or other devices in the laboratory Suitable for correct performance of tests and/or calibrations, validations and verifications Meet laboratory's requirements, and comply with the relevant standard specifications, as well as be verified and/or calibrated (see Part One, 5) 8. Equipment, instruments and other devices 8.1 Equipment, instruments and other devices must be designed, constructed, adapted, located, calibrated, qualified, verified and maintained to suit the operations to be carried out in the local environment. The user should purchase the equipment from an agent who will be able to provide full technical support, and maintenance at the time of need. Documentation should be written in the language employed in the laboratory. 8.2 So as to promote proper sampling, and measurement, the laboratory must have the required test equipment, instruments or other devices for the correct performance of the tests and/or calibrations, validations and verifications (including preparation of test and/or calibration items, processing and analysis of test and/or calibration data). As a guide a list of basic equipment, instruments and other devices is given in Appendix 2. 8.3 Equipment, instruments and other devices, including those used for sampling, must meet the laboratory's requirements, and comply with the relevant standard specifications, as well as be verified and/or calibrated (see Part One. 5). Part One. 8.1 – 8.3

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