WHO GMP Workshop on Quality

7/30/2019 WHO GMP Workshop on Quality

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WHO Constitution


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International health standards

WHO Constitution Article 2:to act as the directing and

coordinating authority oninternational health work.


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FUNCTIONS OF WHO

To act as the directing andcoordinating authority oninternational health work

To develop, establish andpromote international standards

with respect to food, biological,pharmaceutical and similarproducts.


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Standards with respect to the safety,

purity and potency of biological,pharmaceutical and similar productsmoving in international commerce;

Advertising and labeling of biological,pharmaceutical and similar productsmoving in international commerce;

The Health Assembly shall have

the authority to adopt concerning:

STANDARD SETTING FUNCTION


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Strategy Components

Medicines policy

Access

Quality and safety

Rational use


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Quality System

Most developing countries lack thecomprehensive set-up of a national qualitysystem as defined by WHO An appropriate

infrastructure, encompassing theorganizational structure, procedures,processes and resources necessary toensure adequate confidence that aproduct (or service) will satisfy givenrequirements for quality


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Quality and Safety

The quality, safety andefficacy of all medicinesassured by strengtheningand putting into practiceregulatory and qualityassurance standards


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Medicines regulation andquality assurance systems

WHO Objective

Instruments for effective drugregulation and quality assurance

systems promoted in order tostrengthen national drugregulatory authorities.


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ChallengesThree types of common imbalance havebeen identified in regulatory practice

Much more time is assigned to pre-marketingassessment than to post marketing surveillance

While product registration is considered a majorresponsibility by all the drug regulatoryauthorities, the regulation of drug distribution

channels and information does not enjoy thesame level of attention

In many countries, GMP inspection receives

more attention and resources than inspection ofdistribution channels


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With the technical support of WHO, apostgraduate university degree courseon pharmaceutical good manufacturing

practices (GMP) was developed in theIslamic Republic of Iran which can beused for capacity-building for countries

of the Region. Technical support wasprovided for training workshops on goodmanufacturing practices in severalcountries.

Some examples of WHOtechnical support


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Technical support was providedfor fellowships for differentissues related to qualityassurance and safety ofmedicines and vaccines, a inaddition to Who publications onquality and safety of medicines.


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Quality assurance ofPharmaceuticals

A compendium of guidelinesand related materials

Volume 2, 2nd updated edition

Good manufacturing practices

and inspection


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The quality of pharmaceuticals has been aconcern of the World Health Organization

(WHO) since its inception. The setting ofglobal standards is requested in Article 2 ofthe WHO Constitution, which cites as one of

the Organizations functions that it shoulddevelop, establish and promote

international standards with respect to food,biological, pharmaceutical and similarproducts.


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World Health Assembly continues to expressgreat concern about the quality, safety andefficacy of medicines, particularly those productsor active pharmaceutical substances imported

into, or produced in, developing countries. Inrecent years counterfeit products have infiltratedcertain markets in disquieting proportions. Since

the founding of WHO, the World HealthAssembly has adopted many resolutionsrequesting the Organization to developinternational standards, recommendations and

instruments to assure the quality of medicines,whether produced and traded nationally orinternationally.


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In response to these resolutions, the WHOExpert Committee on Specifications for

Pharmaceutical Preparations, which wasoriginally created to prepare TheInternational Pharmacopoeia, has madenumerous recommendations relevant toquality assurance and control.


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The recommendations are essential to all

concerned with the quality assurance ofmedicines, but separate publications overa period of years has made it difficult to

recognize them as complementary parts ofa comprehensive system of quality

assurance.


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Volume 1 of Quality assurance of

pharmaceuticals: a compendium ofguidelines and related materialswas

published by WHO in 1997. Materialrelating to national drug regulations,product assessment and registration


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Volume 2, first published by WHO in 1999,reproduces guidelines related to goodmanufacturing practices (GMP) and to the

inspection of pharmaceutical manufacturersand drug distribution channels. This volume

was updated in 2004, and the currentversion constitutes the second updatededition of Volume 2 including new texts and

revisions adopted to date as WHOguidelines.


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GMP are an important part of acomprehensive system of quality

assurance. They also represent thetechnical standard upon which is based the

WHO Certification Scheme on theQuality of Pharmaceutical Products Movingin International Commerce.


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The first GMP text published by WHO wasdeveloped during 196769 upon request

by WHOs Member States and wasrevised in 1975. In the 1980s and early

1990s, several national and regional drugregulatory authorities issued or revisedguidelines reflecting the ongoing

elaboration of the concept of GMP.


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Revised and expanded GMP guidelines

were prepared during 198990, approvedby the WHO Expert Committee onSpecifications for Pharmaceutical

Preparations in late 1990 andsubsequently published by WHO.


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GMP guidelines published by WHO are

to be regarded as advisory in nature and

may need to be adapted to addressspecific conditions in individual countries.

However, if any departures fromrecommended practices are introduced,

the equivalence of such alternativeapproaches should be validated.


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The GMP guidelines for biological products

The GMP guidelines for the manufacture ofinvestigational pharmaceutical products

The specialized GMP guidelines for themanufacture of herbal medicinal products

Radiopharmaceuticals close collaboration with

the International Atomic Energy Agency (IAEA). Guidelines for inspection of drug distribution

channels

Specialized Guidelines


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Inspection is closely related to otherelements of the overall medicines qualityassurance system: GMP, licensing of

manufacturing facilities, productregistration.


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Provisional guidelines on the inspection of

pharmaceutical manufacturers waspublished by WHO in 1992 along with thecore GMP guidelines.


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Additional guidelines dealing with thequality system requirements for nationalgood manufacturing practice inspectorates

were adopted by the Expert Committee.


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WHO good manufacturingpractices: main principles for

pharmaceutical products


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General considerations

Licensed pharmaceutical products(marketing authorization) should bemanufactured only by licensedmanufacturers (holders of a manufacturingauthorization) whose activities are regularlyinspected by competent nationalauthorities.


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Glossary

The definitions given below apply to the

terms used in this guide. They may havedifferent meanings in other contexts.


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Quality management in the drugindustry

The basic elements of quality managementare:

an appropriate infrastructure or quality system,encompassing the organizational structure,procedures, processes and resources;

systematic actions necessary to ensure adequateconfidence that a product (or service) will satisfygiven requirements for quality. The totality of

these actions is termed quality assurance.


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Quality assuranceQuality assurance is a wide-ranging concept

covering all matters that individually orcollectively influence the quality of a product. It isthe totality of the arrangements made with the

object of ensuring that pharmaceuticalproducts are of the quality required for theirintended use. Quality assurance therefore

incorporates GMP and other factors, includingthose outside the scope of this guide such asproduct design and development.


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Good manufacturing practices for

pharmaceuticalproducts (GMP)

Good manufacturing practice is that part of qualityassurance which ensures that products areconsistently produced and controlled to the quality

standards appropriate to their intended use and asrequired by the marketing authorization. GMP areaimed primarily at diminishing the risks inherent inany pharmaceutical production. Such risks areessentially of two types: cross-contamination (inparticular of unexpected contaminants) and mix-ups(confusion) caused by, for example, false labels

being put on containers.


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National Drug Quality

Assurance System


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The quality of medicine Varies greatly-

especially in low-and middle-incomecountries. While most countries have amedicines regulatory authority and formal

requirements for registering medicines,one-third of WHO Member Sates haveeither no regulatory authority or only

limited capacity to regulate the medicinesmarket.


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Main Challenges

Legal framework Qualified national expertise in GMP

inspection

Teaching GMP and Quality Assurance atuniversities

Continued education and on job training Quality system


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Legal Framework

Many developing countries do nothave the national expertise todevelop national legal frameworkfor GMP standard and GMP

national inspection system


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Developing countries usuallyadopt one of the recognizednational, regional, or global GMP

rules. WHO/GMP are generallyaccepted.

The development of the NationalInspection Manual and the LegalFramework of the GMPInspection system needsadditional technical support.


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Qualified national expertisein GMP Inspection

Most of the national regulatoryAuthorities in developing countrieslack the necessary personnel withthe appropriate qualification andexpertise in developing and runningan efficient national system in GMPInspection


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The available facilities and working

conditions do not attract competentpersonnel to work in thegovernmental sector


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Teaching GMP and QualityAssurance System at

universitiesOnly recently schools ofpharmacy in developingcountries started teaching basicprinciples of medicines QualityAssurance System and GMPinspection to the pharmacy

under-graduate students


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Continued education andon job training

Very few countries regularly organizecontinued education programmeand on job training courses to GMP

inspectors and other qualityassurance system staff

These activities are mainlydependent on external sources

from donors and UN agencies


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Recommendations andconclusions:

Establishment of national qualitysystem

Pharmacy education

Professional development

Partnership and collaboration


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Quality systemsrequirements for national

good manufacturing practiceinspectorates


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Administrative structureThe administrative structure,

membership, operation and legalstatus of the GMP inspectorate should

be described in the quality manual.

The quality manual should show howall personnel working for the GMP

inspectorate, including subcontracted

staff or advisers, and persons servingon committees providing advice, can

maintain their impartiality


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Organizational structure

The GMP inspectorate should have

an organization that enables it tomaintain the capability to performits technical functions satisfactory

The GMP inspectorate should


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The GMP inspectorate should

have: Documentation clearly identifying its legal status

An organizational chart showing clearly theresponsibility and reporting structure of theinspectorate and, in particular, the relationship

between its inspection and authorization (licensing)functions

A description of the means by which theinspectorate obtains financial support

A description of the relationship between the GMPinspectorate and other departments within the drugregulatory authority and other governmentagencies, where they operate as separate bodies.


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Inspection personnelThe credibility of the GMP inspection

process will depend to a large degree onthe technical competence and integrity ofthe inspectors. The quality manual

should provide up-to-date details of thenames, qualifications, experience andterms of reference (job description and

duties to be performed) of each memberof staff engaged in the GMP inspection

process


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Pharmacy Education

GMP and quality system coursesshould be part of the core

curriculum of undergraduatepharmacy education

P t hi d


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Partnership andCollaboration

More technical support to developingcountries is needed from UN agenciesand other partners

Bilateral, subregional and regionalcollaboration has proven to be very

successful in improving the nationalquality assurance system

WHO GMP Workshop on Quality

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