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Quality Control. Rutendo Kuwana Technical Officer, WHO, Geneva. Training workshop: Training workshop on regulatory requirements for registration of Artemisinin based combined medicines and assessment of data submitted to regulatory authorities, February 23-27, 2009, Kampala, Uganda.

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Quality Control

Rutendo Kuwana

Technical Officer, WHO, Geneva

Training workshop: Training workshop on regulatory requirements for registration of Artemisinin based combined medicines and assessment of data submitted to regulatory authorities, February 23-27, 2009, Kampala, Uganda.


Supplementary Training Modules on Good Manufacturing Practice

Good Practices for Quality Control Laboratories

WHO Technical Report Series, No. 902, 2002. Annex 3

quality control
Quality Control


  • 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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Quality Control

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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Quality Control

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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Quality Control

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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Quality Control

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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Quality Control

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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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

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Quality Control

The quality manual should contain at least (continued):

  • Procedure for dealing with complaints
  • A flow chart for samples – QA is responsible for reviewing and approving sampling procedures. Sampling may be conducted by other persons provided they have been appropriately trained
  • 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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Quality Control

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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Quality Control


  • 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

use of notebooks
Use of Notebooks
  • Bound and pre-numbered
  • Loose sheets – pre-numbered, printing controlled and should be stored as control records
  • Electronic data collection system

Raw data should be recorded at the time of production

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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

testing methods and results
Testing Methods and Results
  • Analytical methods and test procedures should be cross referenced (e.g. pharmacopoeia) or detailed to be understood by the local analyst.
  • Formulae – with explanations and simplifications. This makes easy review by a second person
out of specification results
Out of Specification Results

Must be handled based on a written procedure, that includes:

  • Checklist of potential defects (e.g. calculations, methods, visual appearance, test procedure modified, experience of analyst during test, calibration of equipment …)
  • Similar checklist for potential deviations in production
  • Checking sampling and sampling devices
  • Guidance on when re-sampling and re-testing may be required and documented justification in each instance
  • Inclusion of known control sample in any testing
approval and rejection of results
Approval and Rejection of Results
  • Before approval or rejection – criteria to be used and results to be averaged should be specified in SOP(s)
  • Criteria to include - averaging and/or rounding results and comparing results against specifications
  • Control charts can be used to detect trends and atypical results (see
  • Rounding results should be according to pharmacopoeial requirements (see also ICH Q3A)

NB: take care when averaging results from atypical values e.g. outliers, or single result out of specification limits

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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

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Quality Control

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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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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  • 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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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 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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Premises - 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. –

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Quality Control

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

Part One. 8.1 – 8.3

use of primary and secondary standards
Use of Primary and Secondary Standards
  • SOP required on – use, records, acquisition, identification and storage
  • For Pharmacopoeial methods – reference standards should be acquired from that pharmacopoeia.
  • Secondary standards to be routinely tested against the primary standard
  • When a non-Pharmacopoeial standard is used as a reference for assay the mean and standard deviation of the assigned assay value should be known. Retest/expiration date should be assigned