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Good Practices for Quality Control Laboratories Part 1: Introduction, management and infrast ructure

Supplementary Training Modules on Good Manufacturing Practice. Good Practices for Quality Control Laboratories Part 1: Introduction, management and infrast ructure. WHO Technical Report Series, No. 902, 2002. Annex 3. Quality Control. Objectives

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Good Practices for Quality Control Laboratories Part 1: Introduction, management and infrast ructure

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  1. Supplementary Training Modules on Good Manufacturing Practice Good Practices for Quality Control Laboratories Part 1: Introduction, management and infrastructure WHO Technical Report Series, No. 902, 2002. Annex 3

  2. Quality Control 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.

  3. Quality Control 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.

  4. Quality Control 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.

  5. Quality Control 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.

  6. Quality Control 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 1.1– 1.2

  7. Quality Control 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 Part One. 1.3

  8. Quality Control 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") Part One. 1.4

  9. Quality Control 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 Part One. 2.1

  10. Quality Control 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

  11. Quality Control 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

  12. Quality Control 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

  13. Quality Control • 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 Part One. 2.2- 2.3

  14. Quality Control 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 Part One. 3.1

  15. Quality Control 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. Part One. 4.1 – 4.2

  16. Quality Control 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 Part One. 4.3

  17. Quality Control 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 Part One. 4.4

  18. Quality Control 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

  19. Quality Control 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 Part One. 5.1

  20. Quality Control 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 Part One. 5.1

  21. Quality Control 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 Part One. 6.1 – 6.3

  22. Quality Control 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 Part One. 6.4 – 6.5

  23. Quality Control Managerial and technical personnel: • Head of laboratory (supervisor) • Head of central registry • Analysts • Technical staff • Head of central store • Quality Manager Part One. 6.6

  24. Quality Control 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 Part One. 6.6.1

  25. Quality Control 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 Part One. 6.6.2

  26. Quality Control 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) Part One. 6.6.3 – 6.7.2

  27. Quality Control 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 Part One. 6.7 – 6.8

  28. Quality Control 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 Part One. 7.1 – 7.5

  29. Quality Control 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 Part One. 7.6 – 7.7

  30. Quality Control 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 Part One. 7.7.1.1 – 7.7.1.4

  31. Quality Control 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 Part One. 7.7.1.4 – 7.10

  32. Quality Control 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 Part One. 7.10

  33. Quality Control 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) Part One. 8.1 – 8.3

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