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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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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

quality control
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.

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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.

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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.

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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.

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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

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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

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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

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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

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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

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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

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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

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  • 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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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