QCLabs_Part3

7/31/2019 QCLabs_Part3

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QC | Slide 1 of 25 June 2006

Good Practices for Quality Control

Laboratories

Part 3:

Working procedures and safety

Supplementary Training Modules on

Good Manufacturing Practice

WHO Technical Report Series, No.

902, 2002. Annex 3


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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

Quality ControlQuality Control


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Test request can be filled out during sampling - accompany eachsample submitted to the laboratory, and should contain thefollowing information, e.g.:

source of the material

full description including its International NonproprietaryName (INN), concentration or strength, manufacturer, andbatch 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 eachsample submitted to the laboratory, and should contain thefollowing information (continued):

size of the consignment from which it was taken, whenappropriate

expiry date (pharmaceutical product) retest date (startingmaterial, pharmaceutical excipients)

pharmacopoeia specifications or other official specifications tobe 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




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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




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Storage

The sample prior to testing, the retained sample and any remainingportions of the sample after performance of all required tests mustbe stored safely (storage conditions)

Analysis is determined by the head

The sample must be stored until all relevant documentation hasbeen received

Request for analysis may be accepted verbally only in case ofemergencies

Data recorded on the analytical worksheet

Copies or duplicates of all documentation must accompany eachnumbered sample when sent to the specific unit

Part Three. 14.11- 14.17



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Analytical worksheetAn 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).




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The analytical worksheet must provide or leave space for thefollowing 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 thefollowing 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, signedby 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

Manufacturers 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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Filing

Analytical worksheet filed for safe keeping together with anyattachments, including calculations and tracings of instrumentalanalyses

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 theworksheet

Mistakes, amended data or text old information may bedeleted by a single line (not erased nor made illegible) and thenew information added alongside, initialled or signed, and anexplanation for the change given




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TestingTesting 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 responsibleperson 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 andthe 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 meetspecifications?

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 toerror, which has been identified

All conclusions entered on the analytical worksheet by theanalyst and initialled by the supervisor




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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, whereappropriate

reference to the specification(s) used for testing the sample,including limits

results of all tests performed, numerical results of all testsperformed (if applicable)

conclusion whether or not the sample was found to meet thelimits 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 receivedexpiry 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 beingcarried out

prohibition of smoking, eating, and drinking in the laboratory

familiarity with the use of fire-fighting equipment, including fireextinguishers, fire blankets, and gas masks

the use of laboratory coats or other protective clothing includingeye protection

Part Four. 19.1 19.2



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(continued)

special handling as required, e.g. for highly potent, infectious orvolatile substances

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

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

observation of safety rules in handling cylinders of compressedgases and familiarity with their colour identification codes

awareness of avoiding solitary work in the laboratoryprovision of first-aid materials and instruction in first-aid

techniques, emergency care, and use of antidotesPart 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, corrosivereagents, and solvents, and particularly in the use of safety containersor baskets to avoid spillage from containers

Warnings, precautions and instructions must be given

Safe disposal of unwanted corrosive or dangerous products byneutralization or deactivation

Safe and complete disposal of mercury and its saltsPart 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


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