1 / 33

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

ace
Download Presentation

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

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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

More Related