IPA/AAPS/FIP Workshop on Quality
Wednesday 20 and Thursday 21 February 2008The Hyatt Regency Hotel,
Mumbai, India
“Good manufacturing Practices for 21st Century ”
WHO-GMP Perspectives
By Dr Abdel Aziz SalehSpecial Adviser to the Regional Director
WHO/EMRO
International health standards
WHO Constitution Article 2:“to act as the directing and coordinating authority on international health work.”
FUNCTIONS OF WHOTo act as the directing and coordinating authority on international health workTo develop, establish and promote international standards with respect to food, biological, pharmaceutical and similar products.
Standards with respect to the safety, purity and potency of biological, pharmaceutical and similar products moving in international commerce;Advertising and labeling of biological, pharmaceutical and similar products moving in international commerce;
The Health Assembly shall have the authority to adopt concerning:
STANDARD SETTING FUNCTION
Quality SystemMost developing countries lack the comprehensive set-up of a national quality system as defined by WHO “An appropriate infrastructure, encompassing the organizational structure, procedures, processes and resources necessary to ensure adequate confidence that a product (or service) will satisfy given requirements for quality”
Quality and Safety
The quality, safety and efficacy of all medicines assured by strengthening and putting into practice regulatory and quality assurance standards
Medicines regulation and quality assurance systems
WHO ObjectiveInstruments for effective drug regulation and quality assurance systems promoted in order to strengthen national drug regulatory authorities.
ChallengesThree types of common imbalance have been identified in regulatory practice
Much more time is assigned to pre-marketing assessment than to post marketing surveillanceWhile product registration is considered a major responsibility by all the drug regulatory authorities, the regulation of drug distribution channels and information does not enjoy the same level of attentionIn many countries, GMP inspection receives more attention and resources than inspection of distribution channels
With the technical support of WHO, a postgraduate university degree course on pharmaceutical good manufacturing practices (GMP) was developed in the Islamic Republic of Iran which can be used for capacity-building for countries of the Region. Technical support was provided for training workshops on good manufacturing practices in several countries.
Some examples of WHO technical support
Technical support was provided for fellowships for different issues related to quality assurance and safety of medicines and vaccines, a in addition to Who publications on quality and safety of medicines.
Quality assurance ofPharmaceuticals
A compendium of guidelinesand related materials
Volume 2, 2nd updated editionGood manufacturing practices
and inspection
The quality of pharmaceuticals has been a concern of the World Health Organization (WHO) since its inception. The setting of global standards is requested in Article 2 of the WHO Constitution, which cites as one of the Organization’s functions that it should “develop, establish and promote international standards with respect to food, biological, pharmaceutical and similarproducts.”
World Health Assembly continues to express great concern about the quality, safety and efficacy of medicines, particularly those products or active pharmaceutical substances imported into, or produced in, developing countries. In recent years counterfeit products have infiltrated certain markets in disquieting proportions. Since the founding of WHO, the World Health Assembly has adopted many resolutions requesting the Organization to develop international standards, recommendations and instruments to assure the quality of medicines,whether produced and traded nationally or internationally.
In response to these resolutions, the WHO Expert Committee on Specifications for Pharmaceutical Preparations, which was originally created to prepare The International Pharmacopoeia, has made numerous recommendations relevant to quality assurance and control.
The recommendations are essential to all concerned with the quality assurance of medicines, but separate publications over a period of years has made it difficult to recognize them as complementary parts of a comprehensive system of quality assurance.
Volume 1 of Quality assurance of pharmaceuticals: a compendium of guidelines and related materials was published by WHO in 1997. Material relating to national drug regulations, product assessment and registration
Volume 2, first published by WHO in 1999, reproduces guidelines related to good manufacturing practices (GMP) and to theinspection of pharmaceutical manufacturers and drug distribution channels. This volume was updated in 2004, and the current version constitutes the second updated edition of Volume 2 including new texts and revisions adopted to date as WHO guidelines.
GMP are an important part of a comprehensive system of quality assurance. They also represent the technical standard upon which is based the WHO Certification Scheme on theQuality of Pharmaceutical Products Moving in International Commerce.
The first GMP text published by WHO was developed during 1967–69 upon request by WHO’s Member States and was revised in 1975. In the 1980s and early 1990s, several national and regional drug regulatory authorities issued or revised guidelines reflecting the ongoing elaboration of the concept of GMP.
Revised and expanded GMP guidelines were prepared during 1989–90, approved by the WHO Expert Committee on Specifications for PharmaceuticalPreparations in late 1990 and subsequently published by WHO.
GMP guidelines published by WHO areto 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.
The GMP guidelines for biological productsThe GMP guidelines for the manufacture of investigational pharmaceutical productsThe specialized GMP guidelines for the manufacture of herbal medicinal productsRadiopharmaceuticals close collaboration with the International Atomic Energy Agency (IAEA).“Guidelines for inspection of drug distribution channels”
Specialized Guidelines
Inspection is closely related to other elements of the overall medicines quality assurance system: GMP, licensing of manufacturing facilities, product registration.
“Provisional guidelines on the inspection of pharmaceutical manufacturers” was published by WHO in 1992 along with the core GMP guidelines.
Additional guidelines dealing with the quality system requirements for national good manufacturing practice inspectorates were adopted by the Expert Committee.
General considerationsLicensed pharmaceutical products (marketing authorization) should be manufactured only by licensed manufacturers (holders of a manufacturing authorization) whose activities are regularly inspected by competent nationalauthorities.
Glossary
The definitions given below apply to the terms used in this guide. They may have different meanings in other contexts.
Quality management in the drug industry
The basic elements of quality management are:
— an appropriate infrastructure or “quality system”, encompassing the organizational structure, procedures, processes and resources;
— systematic actions necessary to ensure adequate confidence that a product (or service) will satisfy given requirements for quality. The totality of these actions is termed “quality assurance”.
Quality assurance“Quality assurance” is a wide-ranging concept covering all matters that individually or collectively influence the quality of a product. It is the totality of the arrangements made with the object of ensuring that pharmaceuticalproducts are of the quality required for their intended use. Quality assurance therefore incorporates GMP and other factors, including those outside the scope of this guide such as product design and development.
Good manufacturing practices for pharmaceuticalproducts (GMP)
Good manufacturing practice is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization. GMP are aimed primarily at diminishing the risks inherent in any pharmaceutical production. Such risks are essentially of two types: cross-contamination (in particular of unexpected contaminants) and mix-ups (confusion) caused by, for example, false labels being put on containers.
The quality of medicine Varies greatly-especially in low-and middle-income countries. While most countries have a medicines regulatory authority and formal requirements for registering medicines, one-third of WHO Member Sates have either no regulatory authority or only limited capacity to regulate the medicines market.
Main Challenges
Legal framework Qualified national expertise in GMP inspectionTeaching GMP and Quality Assurance at universitiesContinued education and on job trainingQuality system
Legal Framework
Many developing countries do not have the national expertise to develop national legal framework for GMP standard and GMP national inspection system
Developing countries usually adopt one of the recognized national, regional, or global GMP rules. WHO/GMP are generally accepted.
The development of the National Inspection Manual and the Legal Framework of the GMP Inspection system needs additional technical support.
Qualified national expertise in GMP Inspection
Most of the national regulatory Authorities in developing countries lack the necessary personnel with the appropriate qualification and expertise in developing and running an efficient national system in GMP Inspection
The available facilities and working conditions do not attract competent personnel to work in the governmental sector
Teaching GMP and Quality Assurance System at
universitiesOnly recently schools of pharmacy in developing countries started teaching basic principles of medicines Quality Assurance System and GMP inspection to the pharmacy under-graduate students
Continued education and on job training
Very few countries regularly organize continued education programmeand on job training courses to GMP inspectors and other quality assurance system staff
These activities are mainly dependent on external sources from donors and UN agencies
Recommendations and conclusions:
Establishment of national quality systemPharmacy educationProfessional development Partnership and collaboration
Administrative structureThe administrative structure,
membership, operation and legal status of the GMP inspectorate should
be described in the quality manual. The quality manual should show how
all personnel working for the GMP inspectorate, including subcontracted staff or advisers, and persons serving on committees providing advice, can
maintain their impartiality
Organizational structure
The GMP inspectorate should have an organization that enables it to maintain the capability to perform its technical functions satisfactory
The GMP inspectorate should have:Documentation clearly identifying its legal statusAn organizational chart showing clearly the responsibility and reporting structure of the inspectorate and, in particular, the relationship between its inspection and authorization (licensing) functionsA description of the means by which the inspectorate obtains financial supportA description of the relationship between the GMP inspectorate and other departments within the drug regulatory authority and other government agencies, where they operate as separate bodies.
Inspection personnelThe credibility of the GMP inspection
process will depend to a large degree on the technical competence and integrity of
the inspectors. The quality manual should provide up-to-date details of the names, qualifications, experience and terms of reference (job description and
duties to be performed) of each member of staff engaged in the GMP inspection
process
Pharmacy Education
GMP and quality system courses should be part of the core
curriculum of undergraduate pharmacy education
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