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Good Practices for Quality Control Laboratories


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Title: Good Practices for Quality Control Laboratories

Supplementary Training Modules on Good
Manufacturing Practice
Good Practices for Quality Control
Laboratories WHO Training material amended by
Dr. AJ van Zyl for the training workshop in Dar
Es Salaam, Tanzania, August 2006
WHO Technical Report Series, No. 902, 2002.
Annex 3
Quality Control
  • Introduction
  • This QC training module consists of 4 parts
  • Part 1 Management and organization
  • Part 2 Materials, equipment, instruments and
  • Part 3 Working procedures and documents, and
    safety in the laboratory
  • Part 4 Inspecting the laboratory

Part One.
Quality Control
  • Objectives
  • To discuss Good Practices for Quality Control
    laboratories including quality systems and
  • 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
Part One. Management and infrastructure 1.
Organization and management 2. Quality system 3.
Control of documentation 4. Records 5. Data
processing equipment 6. Personnel 7. Premises 8.
Equipment, instruments and other devices
Quality Control
Part Two. Materials and set-up of equipment,
instruments and other devices 9. Specifications
archive 10. Reagents 11. Reference materials 12.
Calibration, validation and verification of
equipment, instruments and other devices 13.
Quality Control
Part Three. Working procedures 14. Incoming
sample 15. Analytical worksheet 16. Testing 17.
Evaluation of test results 18. Retained
samples Part Four. Safety in pharmaceutical
control laboratories 19. General rules
Quality Control
  • Background
  • Recommendations relevant to quality control
    testing at the site of the pharmaceutical
  • Laboratory provides a service - like a
    manufacturing unit
  • products include test results, advice and
  • Needs
  • buildings, personnel, resources
  • equipment, raw materials
  • quality assurance program

Part One.
Quality Control
  • When starting to review compliance e.g. during
  • Preparation with background information
  • Materials and products
  • SMF
  • Product dossier (e.g. specifications, tests)

Quality Control
  • Assess implementation and compliance with all the
  • GMP
  • GP NCL
  • Different approaches (systematic, material or
    product flow)

Quality Control
  • Start at laboratory, walk through and assessing
    Organization and management
  • 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.
Quality Control
  • 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

Part One. 7.6. 7.7.
Quality Control
  • Storage areas and 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.
Quality Control
  • Appropriate storage conditions.
  • Storage area with clean bottles, vials, spoons,
    funnels, and labels required for dispensing
    reagents from larger to smaller containers
  • Store keeper responsibilities
  • Store and inventory, expiry dates
  • Areas for flammable substances, for fuming and
    concentrated acids etc
  • Self-igniting materials, such as metallic sodium
    stored separately.

Part Two. 10.7.1. 10.7.3.
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
  • 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

Part One. 7.10.
Quality Control
  • 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.
Quality Control
  • 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
  • Readily available, and include date of
    confirmation of competence, plus criteria for
    confirmation and name of the confirming

Part One. 6.4 6.5
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
Quality Control
  • Quality system
  • Management to establish, implement and maintain
    quality system that covers policies, systems,
    programmes, procedures and instructions
  • Communicated, available, understood and
  • Documented in a quality manual
  • available to the laboratory personnel
  • maintained and updated by a responsible person

Part One. 2.1.
Quality Control
  • The quality manual should contain at least
  • Organizational chart operational and functional
  • General and specific quality assurance
  • Proficiency testing schemes
  • Use of reference materials
  • Feedback and corrective action (for testing
  • 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 and
  • A quality policy statement.

Part One. 2.1.
Quality Control
  • The quality policy should include at least
  • A statement of the standard of service it will
  • 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
  • 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.
Quality Control
  • Control of documents
  • Documentation (essential part of QA)
  • 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.
Quality Control
  • SOPs Written and authorized
  • For administrative and technical operations, such
  • Purchase and receipt of consignment of materials
  • e.g. samples, reference material, reagents
  • Internal labelling, quarantine, and storage of
  • Appropriate installation of each instrument and
  • Sampling and inspection
  • Testing materials, describing the methods and
    equipment used

Part One. 4.4.
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.
Quality Control
  • Verify compliance (in practice)
  • From register, select a batch of API, excipient
    and finished product
  • Request specifications and test methods
  • Retention samples
  • Verify information in register against sampling
    sheet, PO, delivery note, incoming goods
    register, analytical report, sampling SOP etc

Quality Control
  • Specifications archive
  • Current versions of all specifications
  • Pharmacopoeia compendia or in manufacturers'
    registration documents.
  • Archive must contain
  • List of all pharmacopoeias in the laboratory
  • all updates and corrections must be noted
  • adequate numbers of supplements and addenda.
  • File of non-pharmacopoeia quality specifications
  • numbered and dated, latest version
  • information relevant to the status of the
    quality specifications
  • corrections or changes appropriately handled,
    including producing a revised document as soon as

Part Two. 9.1. 9.2.
Quality Control
  • Specifications archive
  • Use of the master copy
  • photocopies accounted for and controlled for use
  • Confidentiality of specifications
  • Responsibility defined for
  • Updating all pharmacopoeias - including
    supplements, addenda, and corrective measures
    used in the laboratory
  • Maintaining a specifications file

Part Two. 9.3. 9.5.
Quality Control
  • E.g. Artesunate
  • What should you look for initially?

Quality Control
  • Incoming samples (Sampling plan and procedures)
  • Sample size sufficient for
  • the tests to be performed
  • replicate tests
  • retained / retention sample
  • The laboratory must have a sampling plan and
    internal procedure for sampling, available to all
    analysts and technicians within the laboratory

Part Three. 14.1.1. 14.4.3.
Quality Control
  • Test request can be filled out during sampling -
    accompany each sample submitted to the
    laboratory, and should contain the following
    information e.g.
  • source of the material
  • full description including its International
    Nonproprietary Name, concentration or strength,
    manufacturer, and batch number (if available),
    size of the sample
  • reason for requesting the analysis
  • date on which the sample was collected

Part Three. 14.2.1.
Quality Control
  • (cont)
  • size of the consignment from which it was taken,
    when appropriate
  • expiry date (pharmaceutical product) retest
    date, (starting material, pharmaceutical
  • pharmacopoeia specifications or other official
    specifications to be used for testing
  • record of further comments (e.g. discrepancies
  • required storage conditions

Part Three. 14.2.1.
Quality Control
  • Registration and labelling
  • All samples should be assigned a registration
  • Separate registration numbers - different batches
  • A label with appropriate information on each
    container of the sample

Part Three. 14.3.1. 14.3.2.
Quality Control
  • Central register
  • The following information should be recorded
  • registration number
  • date of receipt
  • specific unit to which the sample was forwarded.
  • Sample received should be inspected
  • the findings must be recorded, dated and
  • discrepancies and damage recorded
  • queries referred back to the provider of the

Part Three. 14.4.1. 14.5.1.
Quality Control
  • Storage
  • The sample prior to testing, the retained sample
    and any remaining portions of the sample after
    performance of all required tests must be stored
    safely (storage conditions)
  • Analysis is determined by the head
  • The sample must be stored until all relevant
    documentation has been received
  • Request for analysis may be accepted verbally
    only in case of emergencies
  • Data recorded on the analytical worksheet
  • Copies or duplicates of all documentation must
    accompany each numbered sample when sent to the
    specific unit.

Part Three. 14.6.1. -14.9.
Quality Control
  • Specification as per dossier
  • Version and reference number
  • Reference to test methods/procedures
  • Test parameters and acceptance limits
  • Verify tests done

Quality Control
  • Identification on sample from each container
  • Verify spectrum and or chromatogram (number of
  • Traceability to instrument used, reference
    standard used, analyst, date, source data
    (preparation of sample e.g. logbook or
  • Refer to the test method for materials required

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.
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.
Quality Control
  • Analytical worksheet
  • An internal document in a printed form for
    recording information
  • Complemented by the raw data obtained in the
  • One used for each numbered sample
  • A further set of analytical worksheets in
    duplicate can be used for a collaborating unit
    (after testing, all results are assembled in one
    analytical worksheet, using the data from all
    collaborating units).

Part Three. 15.1. 15.3.2.
Quality Control
  • The analytical worksheet must provide or leave
    space for the following information
  • registration number of the sample
  • page numbering including total number of pages
    (including annexes)
  • date of the test request
  • date of analysis performed
  • name and signature of analyst
  • description of the sample received
  • reference to the specifications to which the
    sample was tested including limits (adding any or
    special methods employed) - reference number of
    the specifications, if available (e.g.
    pharmacopoeia monograph)

Part Three. 15.4.1.
Quality Control
  • The analytical worksheet must provide or leave
    space for the following information (cont)
  • results obtained of tested sample
  • the interpretation of the results and the final
    conclusions, signed by each of the analysts
    involved and initialled by the supervisor
  • the identity of the test equipment used
  • further comments, for example, for internal

Part Three. 15.4.1.
Quality Control
  • The above information may be complemented by
  • detailed notes on the specifications selected
    and the methods of assessment used
  • whether and when portions of the sample were
    forwarded to other units for special tests (for
    example, mass spectrometry, x-ray diffraction),
    and the date when the results were received
  • identification number of any reference material
  • if applicable, data to be attached of an
    instrument verification
  • if applicable, data to be attached of a reagent

Part Three. 15.4.1.
Quality Control
  • The completed analytical worksheet must be signed
    by the responsible analyst/s and initialled by
    the supervisor.
  • Specifications necessary to assess the sample
  • Particular pharmacopoeia monograph
  • Manufacturers specifications
  • National pharmacopoeia to be used
  • Specifications contained in the product licence,
    and should be the current version

Part Three. 15.4.2. 15.5.2.
Quality Control
  • Verification of data
  • Reference standard (library?), batch number
  • Primary/official standard or working standard
  • Procedure for preparation (who, how, where,
    container, labelling, records, tests, expiry
    date, storage condition)
  • Use log and information file

Quality Control
  • Reference materials have assigned values of a
    quantity. Hierarchy for reference materials
  • Primary chemical substance
  • has appropriate qualities within a specified
    context, and whose value is accepted without
    requiring comparison to another chemical
  • Secondary chemical reference substance
  • - characteristics are assigned and/or calibrated
    by comparison with a primary chemical reference
    substance. The extent of characterization and
    testing of a secondary chemical reference
    substance may be less than for a primary chemical
    reference substance. This definition may apply
    inter alia to some substances termed working
  • International Biological Standards
  • a category of biological reference material
    having World Health Organisation (WHO) status

Part Two. 13.5.1. 13.5.3.
Quality Control
  • Reference materials
  • Used for testing and/or calibration, validation
    or verification of a sample or equipment,
    instruments or other devices
  • Responsibility must be assigned to a specific
  • Registration and labelling with an identification
    number assigned
  • A new identification number to each new batch
  • Number marked on each vial
  • Quoted on the analytical worksheet at every use

Part Two. 11.1. 11.2.4.
Quality Control
  • Central register for reference materials
    containing information
  • identification number of the material
  • precise description of the material
  • source
  • date of receipt
  • batch designation or other identification code
  • intended use of the material (e.g. as an infrared
    reference material, as an impurity reference
    material for thin-layer chromatography, etc.)
  • location of storage in the laboratory, and any
    special storage conditions
  • further indications (e.g. results of

Part Two. 11.3.1 11.3.2.
Quality Control
  • Information file for reference materials
    containing information
  • In addition to the central register - a file
    containing information on the properties of each
    reference material
  • Working standards - include the results of all
    tests and verifications
  • Inspection
  • Inspected at regular intervals, no deterioration,
    appropriate storage conditions
  • Inspections must be recorded in the central
    register and/or the information file
  • See also "The general guideline on the
    establishment, maintenance and distribution of
    reference materials"

Part Two. 11.4.1. 11.6.
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.
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.
Quality Control
  • Reagents
  • Reagents, chemicals, including solvents and
    materials used in tests and assays - of
    appropriate quality and supplied with COA
  • List of pre-qualified suppliers
  • Clear responsibility in job descriptions for the
    preparation of reagents in the laboratory
  • SOPs according to pharmacopoeia or other
  • Records for the preparation, and standardization
    of volumetric solutions

Part Two. 10.1. 10.3.
Quality Control
  • Reagent labels must clearly specify
  • the contents, the manufacturer, the date
    received, and as appropriate, the concentration,
    standardization factor, shelf-life and storage
    conditions (purchased)
  • date of preparation, name and initials of person
    (if prepared in the laboratory)
  • Volumetric solutions
  • the name of the manufacturer of the original
    reagent (where diluted), the date of preparation,
    the date of standardization and factor, and
    identify the responsible technician
  • Reagents must not be moved unnecessarily from
    unit to unit
  • Whenever possible, transportation in original
  • Subdivided in scrupulously clean, fully labelled

Part Two. 10.4-10.5.3.
Quality Control
  • Inspect reagent containers when delivered (e.g.
    seals intact)
  • Inspection recorded on the label giving the date,
    name and initials
  • If tampered with, rejected, unless identity and
    purity can be confirmed
  • Distilled water and deionized water
  • Water should be considered as a reagent.
  • Precautions to avoid contamination during
  • supply, storage and distribution.
  • To comply with pharmacopoeia and other official
    requirements for quality.

Part Two. 10.6.1. -
Quality Control
  • Calibration, validation and verification of
    equipment, instruments and other devices
  • Regular calibration, validation and verification
    of all equipment, instruments and other devices
    used to measure the physical properties of
    substances must be performed
  • Specific procedures for each type of equipment,
    instrument and other devices must be established,
    having regard to the extent of which they are
    used, verified and calibrated at regular
    intervals according to SOP

Part Two. 12 -12.2.
Quality Control
  • The records must include at least the following
  • name of equipment, instrument and other devices
  • manufacturer's name, type identification, serial
    number or other unique identification
  • verification/calibration to comply with the
  • current location, where appropriate
  • the manufacturer's instructions, if available,
    or reference to their location

Part Two. 12.5.
Quality Control
  • The records must include at least the following
  • dates, results and copies of reports,
    verifications and certificates of all
    calibrations, adjustments, acceptance criteria,
    and due date of next verification/calibration
  • maintenance carried out to date and the
    maintenance plan
  • history of any damage, malfunction, modification
    or repair. It is also recommended to keep
    records and additional observations of the time,
    the equipment, instruments or devices were used

Part Two. 12.5.
Quality Control
  • Maintenance procedures and records
  • Prevent contamination or deterioration - perform
    systematic verifications
  • Defective instruments - taken out of service,
    and clearly labelled or marked
  • Status of calibration and the date when
    recalibration is due, indicated
  • Instruments to be satisfactory before being
    returned to service

Part Two. 12.6. 12.10.
Quality Control
  • Performing the tests
  • Official pharmacopoeia requirements - see
    general notices and the specific monographs of
    the pharmacopoeia
  • System suitability done as relevant
  • All values obtained from each test, including
    blank results, must immediately be entered on the
    worksheet, and all graphical data, whether
    obtained from recording instruments or
    hand-plotted must be attached to the analytical

Part Three. 16.3.1. 16.4.
Quality Control
  • Evaluation of test results
  • Results must be reviewed and evaluated do they
    meet specifications
  • Consider the results of all tests
  • Doubtful results should be investigated (Internal
    quality system, OOS investigation etc)
  • Doubtful results can be rejected only if they are
    clearly due to error, which has been identified.
  • All conclusions entered on the analytical
    worksheet by the analyst and initialled by the

Part Three. 17.1. 17.2.
Quality Control
  • Analytical test report must provide the following
  • registration number
  • name and address of laboratory testing the
  • name and address of originator requesting
  • name and description and batch number of the
    sample, where appropriate
  • reference to the specification(s) used for
    testing the sample including limits
  • results of all tests performed, numerical
    results of all tests performed (if applicable)
  • conclusion whether or not the sample was found
    to meet the limits of specifications

Part Three. 17.3.2.
Quality Control
  • Analytical test report must provide the following
    information (cont)
  • date of test performed
  • signature of the head of the laboratory or
    authorized person
  • name and address of repacker/trader, if
  • name and address of original manufacturer
  • compliance to requirements
  • date received
  • expiry date.

Part Three. 17.3.2.
Quality Control
  • Traceability
  • Analytical specificities of each measurement
    procedure and reference material that is used to
    ascertain traceability, must be known.
  • Traceability chain, including measurement
    procedures and reference materials at all levels,
    must be prepared
  • Laboratory investigations - applies to
    measurement procedures as well as to reference
    materials used

Part Two. 13.1. 13.3.
Quality Control
  • Filing
  • Analytical worksheet filed for safe keeping
    together with any attachments, including
    calculations and tracings of instrumental
  • Analytical test report must be prepared on the
    basis of the worksheet
  • Mistakes, amended data or text - old information
    may be deleted by a single line (not erased nor
    made illegible) and the new information added
    alongside, initialled or signed, and an
    explanation for the change given

Part Three. 15.6. 15.8.
Inspecting the QC laboratory
  • Other checks
  • Water system
  • Compressed air
  • Steam
  • Environmental monitoring
  • Waste

Quality Control
  • Safety in the laboratory
  • General aspects to consider. . .

Part Four.
Quality Control
  • General and specific safety instructions must be
  • available to each staff member and
  • supplemented regularly as appropriate (e.g.
    written material, poster displays, audio-visual
    material, and occasional seminars)
  • General rules and SOPs should include
  • availability of safety data sheets to staff
    prior to testing being carried out
  • prohibition of smoking, eating, and drinking in
    the laboratory
  • familiarity with the use of fire-fighting
    equipment, including fire extinguishers, fire
    blankets, and gas masks
  • the use of laboratory coats or other protective
    clothing including eye protection

Part Four. 19.1. 19.2.
Quality Control
  • special handling as required for example for
    highly potent, infectious, or volatile
  • full labelling of all containers of chemicals,
    including prominent warnings (e.g. "Poison",
    "Flammable", "Radiation", etc.) whenever
  • adequate insulation and spark-proofing of
    electrical wiring and equipment, including
  • observation of safety rules in handling
    cylinders of compressed gases and familiarity
    with their colour identification codes
  • awareness of avoiding solitary work in the
  • provision of first-aid materials and instruction
    in first-aid techniques, emergency care, and use
    of antidotes

Part Four. 19.2.
Quality Control
  • Protective clothing must be available, including
    eye protection, masks and gloves
  • Water showers should be installed
  • Rubber suction bulbs used on manual pipettes and
  • Staff must be instructed in the safe handling of
    glassware, corrosive reagents, and solvents, and
    particularly in the use of safety containers or
    baskets to avoid spillage from containers
  • Warnings, precautions and instructions must be
  • Safe disposal of unwanted corrosive or dangerous
    products by neutralization or deactivation
  • Safe and complete disposal of mercury and its

Part Four. 19.3.
Quality Control
  • Poisonous or hazardous products
  • Singled out and labelled appropriately
  • Unnecessary contacts with reagents, especially
    solvents and their vapours, must be avoided
  • The use of known carcinogens and mutagens must be
    limited or totally excluded if required by local
  • Replacement of toxic solvents and reagents by
    less toxic materials or reduction of their use

Part Four. 19.4
Inspecting the QC laboratory
  • Thank you
  • Group sessions