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PharmaceuticalQuality

Assurance

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Quality Assurance• Extremely important nowadays!

community pharmacies < hospital pharmacies << industry and distribution

• It is impossible to learn it• It is possible to understand it (this course

will help)• Bad news (as in the last Semester):

Failure is also possible!

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Quality Assurance

Introductiontrying to understand: what is it

all about?

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Let’s consult the literature

Not the scientific literature like other times

The best „literature”

is not necessarily

a scientific paper,

but a fairy tale

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Once, upon a time...

• There were 4 friends called: Somebody, Anybody, Everybody and Nobody

• There was a work that could do Anybody, but Everybody thought that Somebody will do it, thus, actually Nobody did it...

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…and the consequence was that…

• …Everybody became very angry blaming Somebody, for the work could be done by Anybody, but actually Nobody did it…

• =No quality assurance operated!

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What to do to avoid such a situation?Introduce

(the elements of)Quality Assurance!

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QA introduced• Everybody knows his/her job (job

description, substitution, etc.)• Working operations are described in

Standard Operation Procedures in writing• The work is actually done according to

these • The fact that an actual work has been

performed is documented together with the result. Documents are archived

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QA introduced – what it means?

• My colleague retires (dies, etc.)

• I say good bye (crying)

• I go to his table, read the Standard Operating Procedure and his notes/records

• And I can follow his work exactly where he left it!

BYE!

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Our classic: Murphy

• Murphy’s laws: they emphasise that what can be defective that will be defective (as a rule, in the wrongest time!)

• One example:– if a buttered bread is dropping, it will land with

its buttered side looking to the carpet– if not, it means you buttered the wrong side!

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Example (Our slogen: „Mr. Murphy may always be present…”)

• Lecture with lap-top projection (as now)

• Projector – where is it held, what happens if the key is left home, where is the spare key, who may land another projector, etc.

• Are all these documented in writing?

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Definition of the „QUALITY”

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„Quality”

• It is used in the everyday life, e.g. commodities of (good) quality

• Whatever the quality means: we feel that it is a positive value

• (It costs money!)• If it is value then it is valued• If it is valued: this depends on the

concrete society

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The quality in the sciences

• …part of the real sciences

• Decision on the value – it means we should measure the quality!

• Galilei: „Measure everything what is measurable and make measurable what is not!”

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What may have a „quality”?

• EverythingEverything!

• In general: commodities and services

• Is there any quality of the

- life?

- society? (e.g. policy to help the poor, etc.!)

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„Product”

• It is used in the quality-oriented sciences in the very general meaning!

• Everything is „product”, what is „consumed” during meeting some needs

• In this meaning the services are also „products”!

• (At this moment: the „product” is the knowledge I am just delivering to you!)

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„Production” of the product

In all cases:

• product (to be consumed)

• side-product (useful or not useful)

• waste

Also when the „product” is a service!

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What may affect the quality of a product (using the natural

definition)• performance• characteristics• reliability• general suitability (e.g. an electric device may

be connected to the power supply)• durability• serviceability• esthetics (its appearance)• safety during use

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What may affect the quality pf a service (using the natural definition of quality)

• time and timeliness

• completeness

• politeness

• continuity (you may have info about it)

• availability (also price) and comfort

• accuracy

• readiness to incorporate new ideas

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Quality from the point of view of the producer

Quality defined through conformity• Ability of the technology to assure that the product will

conform to the requirements specified duringplanning• It depends on several factors, such as

– planning and organisation of the production technology– performance ofthe equipments and of the technology– the starting materials– training of workers and management’s control– level of final quality control based on statitical

considerations

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Quality of a product and its price

• This evaluation is also important and needed• The producer’s interest to achieve the

„quality” with affordable costs• It means that the price of the to-be product is

also an important factor of the quality planning!

• The quality characteristics of the product and the costs of its production must be in equilibrium

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What is „quality”?

Philosophical (natural) definition: suitability for the intended purpose papaverine: smooth muscle relactant with a given probability and its known side-effects with their known (lower) probability

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According to this definition, Quality is a phylosophically

determined term: to what extent is the product suitable

for its intended purpose

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Other quality definition

• Quality = satisfaction of the stakeholders and the organisation itself = valued value

• Generally accepted on the standardised field!

• Subjective, for

a) who are the stakeholders,

b) they may not be satisfied at the same time!

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Stakeholders

Small retail shop• final costumers (who buy in the shop to consume)

• other consumers (who buy in the shop to re-sell)

• vendors whom the shop purchases• shop assistants („selling their working power”)

• the Municipality (whom local tax is paid)

• The State (whom the general tax is paid)

• …

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Stakeholders

Travel agencies• those who want to travel• at the target country: hotels, restaurants• local guides• employees of the travel agency• the owner of the building, whom the travel

agency rents the office• Municipality, State…

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Stakeholders and their interest in drug retail

• Guest orders• Guest eats• Guest pays

• 1st people orders• 2nd people eats it• 3rd people pays it

Nonsense?

The restaurant example

Doctor

Patient

Insurance company or the State

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Different stakeholders

• with perhaps different interests• If we want to measure the quality as

stakeholder satisfaction, we should specify– points of view of the measurement– its methodology– the characteristics to be measured– the values (what is positive, what is negative)

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Measuring quality? From „quality control” to

conformity assessment

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Dilemma of „measuring” the quality - definitions

• Philosophical (suitable for the intended purpose) – difficult to measure

• Stakeholders’ satisfaction? It seams to be much more measurable, but

• „Who writes the novel, the writer or the reader?”

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Product and consumer needs

• They are interrelated!

• The consumer needs what seems to be realistic on the market

• The market is manipulated (advertising!)

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Conclusion

• The market not always reflects the real needs

• There may be „value” also in cases when there is no consumers’ need

• One may not relay on the „stakeholders’ satisfaction” as the sole quality determinant

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We should measure the „suitability for the intended

purpose”Galilei: „Measure

everything what is measurable and make measurable what is not!”

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Quality control?

If the philosophical (natural) definition of quality applies, can we control it?

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„Quality” and „conformity”

• Do we control the Quality of products? Rarely (e.g. assessment of medicines before their registration, see the papaverine example before)

• This „philosophical” quality should be „translated” to measurable characteristics (requirements with limits + control methods, e.g. legal requirements or standards), and the Conformity of the product to these requirements is analysed/controlled/measured

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Actually…

…speaking - both in the everyday life and in the profession - about quality control, this is the control of the conformity to certain measurable requirements (conformity assessment)

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Conformity assessment

It has different types!

• analytical tests, measurements

• on-the-spot inspection or documentation audit

• exam (!)

Finally: certification of the conformity

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Introduction of the „assured” quality besides (or even

instead of) „controlled” quality

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The quality is, as a rule, not controlled but assured!

• In the everyday life, there is

no other possibility!• The master works in his own shop

producing goods: this, as a rule, assures the quality

• Small sclae manufacture: every manufactured batch is checked

(cont’d)

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The quality is not controlled but assured!

• Large scale manufacture: control based on (statistical) smapling it has inherent problems

• In addition to sample control also the control of the whole manufacturing process „manufactured-in quality instead of analysed-in quality”

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Problems of the statistical sampling

• Certain per cent of failures tolerated (depending on the statistics used)

• The whole system is based on the theory that the distribution of the defective product units may be modelled mathematically (following certain rules)

e.g. Gaussian distribution

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Issues of the control based on statistical sampling, 2

As it is seen in the health-care industryThere is a difference between statistics and health-

care needs:

„Only” 2 dirty infusion bottles among 10,000

„Only” 1 apple with mass phyto protector content among others

- who is administered to with it or eats it represent „his/her 100%”

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Proper attitude

• Quality assurance (e.g. GMP) or terminal batch quality control (analysis according to a sampling plan)? Wrong attitude!

• When GMP is not applied, the result of (statistically taken) sample analysis can not taken as reliable!

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How the quality assurance does work?

In general• We try to avoid

failures (defects)• to find them as soon

as possible or, at least, to prepare ourselves

• to avoid AD HOCAD HOC INTERVENTIONS!INTERVENTIONS!

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Quality Assurance – its various levels and types do exists!

• We think about the „quality” at all• We monitor the qualityand deal with its improvement

(– this has a close connection with the managerial sciences): Total Quality Management

• We prepare process flow technological documents, collect minimum requirements and standards relating to our activities, develop and assess performance indicators (what are they: see later)

• We introduce ISO-based quality assurance and certification, although it is not mandatory in our case (see later)

• Introduce mandatory quality assurance and certification– ISO and „standardised” certification systems– legally required systems: GMP, GDP, GLP, GCP

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TQM

• Total Quality Management

• Characteristic to the fields where the quality is defined by the consumer satisfaction

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TQM, definition

Management of the total organisation with a view to every product and service that may be important for the consumer

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TQM• The consumer determines the quality, his

need is the highest priority• The Management’s priority must be the

quality, not the quantity• Thus way,the quality becomes a strategic

issue• The quality is the responsibility of all

employeees, independently from their position within the organisation

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TQM• The Organisation should, in all procedures,

focus to continuous improvement of the quality otherwiseit can not reach its strategic aims

• Problem solving plus quality improvement uses statitical quality control methods

• The quality problems can be solvedonly through collaboration of the employees and the management

• Continuous education and training of all employees means the basis of the continuous quality development

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From”thinking about the quality” to TQM

How was it introduced and by whom?

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TQM• Walter A. Shewhart was the father of the

statistical process-controll• W. Edwards Deming followed and completed

this – mostly in Japan: „the quality improvement,

although costs money, reduces overall costs, increases productivity and market share” - PDCA

– then in the USA: ”14 points for the Management”

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W. A. Shewhart

He worked for the Western Electric Company. For amplifiers and other equipment had to be buried underground, there was a need to reduce the frequency of repairs. Until that time the quality issues were limited to finl control of the end-product and the elimination of substandard iems. Sewhart, in the twnties of the last century, introduced the concept of the control of manufacturing process

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(folytatás)

• Using the „control chart” method (see later) recognised the difference between chance-cause and assignable-cause quality variations

• He pointed out that every data has bot „signal” and „noise”, these should be separated

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W. Edwards Deming

• Working in the 20th century, mostly in Japan, followed Shewhart’s work

• The Ford company, after World War Two, manufactured cars both in the USA and Japan. The Company became realising that more and more consumers wanted to buy the models manufactured in Japan (where Shewhart acted) for there were less problems with them…

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Deming’s phylosophy

• If the Management concentrates to the quality in the following way:

results of work efforts

quality =

total costs

• then,in the long term, total costs will decrease!• However, if the Management focus mainly to

the reduction of the costs, the qulity will decrease and, in the long term, the costs increase!

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Costs to achieve good quality, 1

• Costs of prevention of wrong quality– quality planning costs– product planning costs– manufacturing costs– training costs– information costs

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Costs to achieve good quality, 2

• Control costs– inspection and product analysis costs– costs of equipments needed to analyses– employment costs of the inspectors and

analysts

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Costs connected with wrong quality, 1

• Internal costs of defective products– no profit, wasting– re-working costs or– losses of decreased price– costs of improvement of the defective

technology– costs of not using the manufacturing

equipments during this time

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Costs connected with wrong quality, 2

• External costs of defective products– dealing with consumer claims– costs of returned goods– costs of expired products– product liability costs– costs of lost partners, buyers

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The price of the quality

External costs ofdefective products

Control costs

Costs of prevention

Internal costs ofdefective products

The price of quality

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W. Edwards Deming

• Plan/Do/Check/Act cycles

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The continuous quality development method: thePDCA cycle (Deming-wheel)

1. Plan a change that may improve the quality

1. Plan

2. Introduce it

2. Do

3. Check the result: did it work?

3. Check

4. Keep it or reject it

4. Act

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Continuous quality development

• How the Management sees the performance of the Organisation?– the performance, that is „continuously challenged

and should be developed step-by-step”

• How the Management seesits own involvement and the role of its work? – believes thatinvolvement of the employees and

the group effortsmay play a key role in the quality development

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Deming: 14 points for Management a)

1. Crate constancy toward quality improvement measures

2. Accept that change is necessary and you are to manage the change

3. Do not ”control in” the quality into the product, „manufacture in” it!

4. Instead of raising the price, get the trust of your consumers instead

5. Improve the quality of the manufacturing process continuously

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Deming: 14 points for Management b)

6. Institute training on the job7. Institut leadership, the aim of the

supervision must be to help people. Control the supervisors!

8. Drive out fear, so that everyone may work effectively!

9. Break down barriers between departments. People must work in team on projects!

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Deming: 14 points for Management c)

10. Forget slogens asking for zero defect and higher productivity

11. Eliminate production quotas12. Permit workers to be proud to their work13. Institute of programof education and self-

improvement14. Explain that the transformation is

everybody’s job

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Deming: „7 Deadly Diseases”

1. Lack of constancy in purposes2. Emphasis on short-term profits3. Evaluation by performance of the

employees, exclusively4. Mobility of management5. Running a company on visible figures

alone 6. Excessive medical costs7. Excessive costs of warranty, fueled by

lawyers who work for contingency fees

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Now, let us think about how we reach the concept of „quality improvement” and why should we define „measuring units” of the quality?

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Levels of Quality Assurance/Management:

„management circles”

PRODUCTION

Model of the „production”

RELEASE

„Production” may mean here also a service!

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Levels of QA

PRODUCTION

DEFECT

RELEASE

No QANo QA There was a defect but no corrective measures to avoid it in the future

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Levels of QA

PRODUCTION

DEFECT

RELEASE

Basic QABasic QA

DEFECT ANALYSIS

CORRECTIVE MEASURES

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Levels of QA

PRODUCTION

DEFECT

RELEASE

Better QABetter QA

DEFECT POSSIBILITY

ANALYSIS

CORRECTIVE MEASURES

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Levels of QA

PRODUCTION

DEFECT

RELEASE

Much better QAMuch better QA

DEFECT POSSIBILITY

ANALYSIS

CORRECTIVE MEASURES

MEASUREMENT OF THE QUALITY

improved

not improved

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How to measure the quality?

• Production: mostly measurable quality characteristics

• Service (e.g. education, regulatory work): performance indicators should be developed for measurement

How to monitor quality?• Perform defect analysis

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Certain methods for defect analysis and quality

monitoring

(examples to understand what we wwere speaking about)

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Method: Rroot Cause Analysis, RCA)

• identify and eliminate the root causes of problems instead ofaddressing the obviuos symptoms merely

• Consider the same defect may be caused by more than one „roots”

• It may be reactive (after the defect) and proactive (not waiting for the defect)

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Root Cause Analysis, RCA

• One intervention is, as a rule, not enough. The RCA is like the mathemathical iteration: reaching the target step by step

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RCA

1. Define exactly: what the problem (that happened) was or could be (if wanted to be avoided)

2. Gather all information, data about it3. Ask why and identify the causal relationships

associated with the problem4. Identify which causes if removed will prevent

recurrence5. Identify effective solutions that prevent

recurrence and are within your control6. Implement them7. Observe the solutions: were they effective?

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RCA-technics (examples)

• Compare what was different when the problem manifested itself and when there was no problem? (Here comes other defect-analytical methods such as – Fishbone diagram– The „five Whys”– Pareto-analysis

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RCA – what to be considered?

• Starting materials– defective raw material– wrong type for the job– lack of raw material

• Equipment– defective– poor placement– poor maintenance– incorrect tool selection

• Methods– no or poor procedures– practices are not the as written

procedures– poor communication

• Environment– forces of nature– wrong layout– not orderly workplace– surfaces poorly maintained

• Management– poor managers– inattention to task– task hazards are not guarded

properly– stress demands– lack of process

understanding• Management system

– education lacking– no local training– poor employee involvement– poor recognition of hazard– previously identified hazards

were not eliminated

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RCA

There are different „schools”, mainly 5:• Risk (safety) based RCA• Manufacture-ased RCA• Process-based (manufacture plus

business) based RCA • Failure-based RCA• SYSTEM-based RCA (=mixture of the previous

ones plus risk-management, change-management and system-analysis)

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Ishikawa’s ”Fishbone diagram” method

failure

one of causes

the main cause

what could be the cause of the latter,

etc.

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Cause & Effect Diagram

Defect

OperatorMachinery

MaterialProcess

Environment

Possible causes:Possible causes: The effectThe effect

Suitable for systematic retrospective analysis of quality defects

Suitable for systematic retrospective analysis of quality defects

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Process flow diagram

No, follow it…

Raw material arrived from the vendor

Check its conformity

Any quality defect?

Return to the vendor at his cost

Yes

Suitable for the identification of a quality defect

Suitable for the identification of a quality defect

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Pareto-analysis

Suitable to recognise that 80% of the defects was caused by 20% of the possible causes

Suitable to recognise that 80% of the defects was caused by 20% of the possible causes

Manuf. process

Def

ect f

requ

ency

Plan-ning

Purchas-ing

Training

Other

80%

20 400 60 80 100

Root of the defects, %

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Run Chart

0.440.460.48

0.50.520.540.560.58

1 2 3 4 5 6 7 8 9 10 11 12Time (hours)

Dia

me

ter

Suitable to recognise that an equipment or process does not work according to planning

Suitable to recognise that an equipment or process does not work according to planning

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HystogramN

o o

f ba

tch

es

ma

nu

fact

ure

d

Data

No of defects

per batch

0 1 2 3 4

suitable to show the frequency of occurring quality defects

suitable to show the frequency of occurring quality defects

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Scatter Diagram

02468

1012

0 10 20 30

Time of training (hours)

No

of d

efe

cts Illustries the connection

between quality improvement and training

Illustries the connection between quality improvement and training

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Check-sheet

Accounting errors

wrong account

wrong quantity

Money collecting errors wrong account

wrong quantity

Monday

Suitable to remember the failures and shows whether the employees collect the data properly

Suitable to remember the failures and shows whether the employees collect the data properly

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Control Charts

970

980

990

1000

1010

1020

0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

LCL

UCL

Suitable for study of process performance and product quality

Suitable for study of process performance and product quality

UCL, LCL: upper and lower conformance limits – to be developed

quality characteristic

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UCL and LCL

• Frequently the upper and lower quality acceptance limits (e.g., for drugs)

• However – purely on statistical basis – when analysisng all measured quantities continuously, one can determine– the actual UCL and LCL values („three sigma

rule”)– the probability that an outlying value comes

„ny chance” (0,27%)– how many consecutive measured points will

not be outlayer, if the process is under control (1/0,0027 = 370)

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Control Charts 1

970

980

990

1000

1010

1020

0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

LCL

UCL

(here the process is under control: only „normal” variation)(here the process is under control: only „normal” variation)

UCL, LCL: acceptance limits

quality characteristic

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Control Charts 2

970

980

990

1000

1010

1020

0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

LCL

UCL

(here the process runs out of the control: unforeseen problem arises)

(here the process runs out of the control: unforeseen problem arises)

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Control Charts 3

970

980

990

1000

1010

1020

0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

LCL

UCL

(here the process has become completely uncontrolled for certain reason)

(here the process has become completely uncontrolled for certain reason)

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A Shingo system (Japan):

Shingo’s arguments:– The „quality control methods” can not

exclude defects– Defects are caused by human failures– This mey be reduced if the workers receive

information on all such cases

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The introduction of the Shingo system in Japan

Poka-Yoke system adds:

– Check-lists

– Special devices hindering workers in making mistakes

e.g. two plugs, with different currents, it is important which plug is connected to which current? Let one of the plug-in and plug-connector triangle-shaped!

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Why are defect-analysis and QA so important? Österreichische

Kranmenhauszeitung 2004

• Also in the health-care, no scapegoat (the person to blame) should be looked for, perform failure analysis instead!

• It means the failures should not hidden, they must be known!

• USA, UK, Switzerlan: Critical Incident Reporting System

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The failures can not be eliminated completely, but their frequency and

seriousness can be decreased!

• Most of the serious failures = if a human error meets a system failure

Why is it so important:Why is it so important:• Statistical data show that 1% of the

errors made in the health-care cause permanent health damage!

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Quality and the marketState general interventions on

the market

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Now think a little about that:

the quality manifests itself during meeting personal needs

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Meeting consumer needs: a process

• Identification of consumer needs• Planning of the product and its

technology• Development of the Manufacturing

system…• …its continuous maintenance• selling the product• „facilitation” of its consumption

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Characteristics of the process of

meeting personal (consumer) needs

• reliability = nodefectin the operation of „meeting needs”until now

• safety: the extent of the risk caused by irregular operation

cyanide in Tisza…

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Meeting consumer needs

It occurs on the market. However, many market types! Its extremes:

• Demand-driven (free): its players to decide, market-driven regulation: value for money – money for value = „standardised field”

• Offer-driven (State- or public market): athe State (or a Donator) purchases, but he affects also the contracts = „regulated field”

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All these have reflections in the quality affairs!

• What type the regulation is

• How reliable is it, e.g. reflects only the quality affairs!

• I.e., to what extent are the steakholders independent when they express their needs. The more the State regulation is the more independent is this, The more the market-driven regulation is the more manipulated market we see…

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Remember the lecture in the last Semester: „Regulated” and „Standardised” fields

Both products and services may be classified into two distinct types, although a strict borderline can not always be drawn

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Standard? Regulation?

Standardised field• Regulated by the

market

• Standards

• Agreement among the players

• Accreditation

Regulated field

Regulated by law or authorities’ decision

Law, Register, Pharmacopoeia,

• Mandatory, enforced

• Authorisation

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Regulated by the market – agreement among the

players…

If the players can not agree, some of the electric goods can not be sold

or or ?

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Levels” of market control

• Higher level: State-driven (public) market

• Lower levels: – ethical market (in-between) – free (demand-driven) market but not

completely free, distorted by advertising, etc.

(As a rule, the mixture occurs, e.g. in the health-care there are always ethical elements such as work on duty)

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Market control by the State

Its aim is to establish a monitoring system suitable to determine the actual state of the market to decide whether State intervention is needed or not (not only quality, also political and economical issue)

If intervention: it is „Quality management” of If intervention: it is „Quality management” of the market by the Statethe market by the State

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Quality management

• Technical-legal rules

• Consumer protection

• Market protection

• Producers’ interest protection

• Market-driven (not mandatory and not directly by the State)

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Technical-legal rules

• Minimum requirements for production or service in laws and regulations

• Measurement policy (e.g. state institution for certain measurement unit calibration)

• National standardisation (also market-driven elements)

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National Consumer Protection

Sanctions executed by State organs• product libility (e.g. law: if a product is

harmful, the producer must compensate the consumer)

• Recall from the market (of defective products)

• Consumer Protection Agency sanctions (e.g. when misleading advertising)

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Market protection

Also State intervention (official rules)• Competition law (the restriction of

competition by big Firms is forbidden)• Misleading marketing is forbidden• Laws regulating contracts• Market surveillance (e.g. taking and

checking samples)

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Producers’ interest protection

• Patent law

• Data Exclusivity (generic medicines!)

• Authors’ right

• Trade mark law

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Market-driven regulation

Accreditation and certification according to

• technical standards

• quality assurance standards

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The organised „standardisation”…

…gives a forum, where the „players” can discuss and „agree”

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Standard

• Elaborated by a non-profit Body, comprising representatives of the „players”, e.g. Hungarian Committee for Standardisation

• Standards based on the ISO (International Standardisation Organisation) standards

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Standards…• …are elaborated to cover every

product and activities (except for those on the regulated field!). Thus, standards are of general character

• Unless the law does not require the use of a standard, they are not binding (but, if they not met, you can not sell your product or service!)

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In the standardised fields

• manufacture of products or offering services need no prior „professional” (i.e. checking your ability to do so) authorisation (naturally, some administrative permission or notification should always be done)

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Accreditation

• Ministers, etc. may define minimal standards necessary for an activity in the regulated field

• Standardisation organisations may also do the same on the standardised field

• Enterpreneurs may request the official Accreditation Body or a Certifying body to check it and accredit them according to the requirements

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Typically

• There is one Accreditation body in every country

• It is a non-profit organisation, founded by the State

• It may accredit Conformity assessing and Certifying bodies (EU terminology = Notified Body)

• These latter are for-profit organisations (as a rule) and they are accredited

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E.g. in Hungary: National Accreditation Council, accredits

the following:• testing laboratories• calibrating lab’s• sampling organisations• organisations managing proficiency testings• notified bodies for product compliance certification• notified bodies for quality management (assurance)

system compliance certification• notified bodies fot persons compliance certification• supervising bodies (except auhorities)• reference material producers• official tender compliance certifying bodies

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What enterpreneurs can do…

• …to prove they are masters in the Art they work in?

• In the EU, there are various quality assurance moduls

• The company, if law does not require one single modul for that activity, may chooes between some moduls to introduce QA

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Examples of conformity assessment moduls, e.g. in the EU

A: based on its own internal manufacturing control (QA based on a standard), the manufacturer itself may declare the suitable quality of its product and put a CЄ mark on it)

A1: the „A” plus product conformity assessment by a notified body regularly, but still the manufacturer declares

B: a notofied body will assess the prototype or the technical plan of the product and the notified body issues a certificate on the complience with standards

etc.

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Thus, there are 3 types of certification according to the

standard:

First party: the Firm „audits” itself e.g. according to ISO 9000 standard(see later)

Second party: the purchaser audits the vendor

Third party: a Notified Body does the audit

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Certifying bodies certify enterprenuers

• to certify that the manufacture or service complies with existing technical standards, or

• to certify that the activities are conducted according to the relevant quality standards

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What is the CЄ?

• Conformité Europenne

• In the European Union, the commodities with the CЄ sign must not be checked/analysed prior to marketing!

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CЄ • The manufacturer puts on the

package

• It means that he declares the given commodity complies with all relevant EU technical standards

• Only to commodities that are listed in the EU law

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Do not forget: on the fully Regulated Field

• Everything is quite different!• You may not start your business (or

sell the outcome) without mandatory prior authorisation, based on requirements specified by the law

• The „controlling” and „certifying” Bodies: authorities!

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Pharmacy and medicine are…

• …on the regulated field!• Professional activities and products

need prior authorisation• The Quality Assurance systems in

the field of pharmacy (in the general meaning) are GMP (GDP), GLP, GCP

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Quality systems characteristics, 1

• Definition of terms!

• Why?

- certain new terms

- terms that are also used in the everyday life in another meaning

- meaning of terms is changing

- translation errors

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Quality System characteristics, 2

• General requirements (soft law) “this and that should adequately be done by the manufacturer”)

• Operating procedures• To be filled-in records (their name may

be different in the various systems)• archivation (everything that can be important

from the point of view of the quality)

Exam topics

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Quality versus conformity assessment

• Definitions of quality (2)• What can one control? (Introduction of the

concept of conformity assessment)• PDCA. The levels of QA (the „circles”)• Historical evolution of QA from QC• Weaknesses of QC based on statistical

sampling (particularly in drug quality testing)

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Regulated and standardised fields

• Speak about their differences• Accreditation, conformity assessing and

certifying bodies• Reason of non-mandatory certification

(outline the situation when you start new business in the standardised or regulated fields)

• Examples for defect analysis techniques

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