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Supplementary Training Modules on Good Manufacturing Practice. Good Practices for Quality Control Laboratories Part 3 : Working procedures and safety. WHO Technical Report Series, No. 902, 2002. Annex 3. Quality Control. Incoming samples (Sampling plan and procedures)

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Supplementary Training Modules on Good Manufacturing Practice

Good Practices for Quality Control Laboratories

Part 3:

Working procedures and safety

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

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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– 14.3

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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 (INN), 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. 14.5– 14.6 (a-f)

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Test request can be filled out during sampling – accompany each sample submitted to the laboratory, and should contain the following information (continued):

  • size of the consignment from which it was taken, when appropriate

  • expiry date (pharmaceutical product) retest date (starting material, pharmaceutical excipients)

  • pharmacopoeia specifications or other official specifications to be used for testing

  • record of further comments (e.g. discrepancies found)

  • required storage conditions

Part Three. 14.6 (g-k)

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Registration and labelling

  • All samples should be assigned a registration number

  • Separate registration numbers – different batches

  • A label with appropriate information on each container of the sample

Part Three. 14.7 – 14.8

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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 initialled

  • discrepancies and damage recorded

  • queries referred back to the provider of the sample

Part Three. 14.9 – 14.10

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  • 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. 14.11- 14.17

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Analytical worksheet

  • An internal document in a printed form for recording information

  • Complemented by the raw data obtained in the analysis

  • 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 – 15.4

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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

Part Three. 15.5

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The analytical worksheet must provide or leave space for the following information (continued):

  • 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)

  • 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, e.g. for internal information

Part Three. 15.5 (a-k)

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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 verification

Part Three. 15.5 (i-v)

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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

  • Manufacturer’s specifications

  • National pharmacopoeia to be used

  • Specifications contained in the product licence, and should be the current version

Part Three. 15.6-15.8

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  • Analytical worksheet filed for safe keeping together with any attachments, including calculations and tracings of instrumental analyses

  • If stored in a central archive – a copy should be retained in the specific unit for easy reference

  • 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. 15.9 – 15.12

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  • Testing performedaccording to the work plan

  • If not feasible, the reasons noted, and the sample stored in a special locked-up place

  • Specific tests by a specialized external laboratory – responsible person should prepare the request and arrange for the transfer of the required number of units (bottles, vials, tablets) from the sample. Each of these units must bear the correct registration number

Part Three. 16.1. – 16.2.

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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 worksheet

Part Three. 16.3 – 16.4.

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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 supervisor

Part Three. 17.1 – 17.2

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Analytical test report:

  • is a compilation of the results and states the conclusion of the examination of a sample

  • issued by the laboratory

  • based on the analytical worksheet

Part Three. 17.3

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Analytical test report must provide the following information:

  • registration number

  • name and address of laboratory testing the sample

  • name and address of originator requesting analysis

  • 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. 17.4

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Analytical test report must provide the following information (continued):

  • date of test performed

  • signature of the head of the laboratory or authorized person

  • name and address of repacker/trader, if applicable

  • name and address of original manufacturer

  • compliance to requirements

  • date received

  • expiry date

Part Three. 17.4

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Retained samples

  • The purpose is to have access to the sample material for a specified period

  • See also basic GMP

Part Three. 18

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  • Safety in the laboratory

    • General aspects to consider. . .

Part Four.

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General and specific safety instructions must be:

  • available to each staff member and

  • supplemented regularly as appropriate (e.g. written material, poster displays, audiovisual 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

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  • special handling as required, e.g. for highly potent, infectious or volatile substances

  • full labelling of all containers of chemicals, including prominent warnings (e.g. "Poison", "Flammable", "Radiation", etc.) whenever appropriate

  • adequate insulation and spark-proofing of electrical wiring and equipment, including refrigerators

  • observation of safety rules in handling cylinders of compressed gases and familiarity with their colour identification codes

  • awareness of avoiding solitary work in the laboratory

  • provision of first-aid materials and instruction in first-aid techniques, emergency care, and use of antidotes

Part Four. 19.2

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  • Protective clothing must be available, including eye protection, masks and gloves

  • Water showers should be installed

  • Rubber suction bulbs used on manual pipettes and siphons

  • 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 given

  • Safe disposal of unwanted corrosive or dangerous products by neutralization or deactivation

  • Safe and complete disposal of mercury and its salts

Part Four. 19.3.

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  • 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 regulations

  • Replacement of toxic solvents and reagents by less toxic materials or reduction of their use

Part Four. 19.4