Pharmaceutical Quality ----- Excellence-----ICH
Pharmaceutical Quality ----- Excellence-----ICH
A pharmaceutical product may be designed and produced in an excellent manner and yet may not give the desired therapeutic effect if it undergoes changes during storage. Even if there is no change in the drug content of the product, loss in therapeutic activity may happen. In a sample of thirty paracetamol tablet products of thirty different companies that were analyzed by one of our scholars, all the tablets showed specified drug content, but two products failed to release their drug content in the expected manner. This might be due to faulty design of the product or physical changes in the product that happened after the tablet came out of the manufacturing house. Loss in therapeutic activity may be due to any one of the following reasons:
1. Physical changes in the dosage form (moisture loss or gain, crystal changes in excipients, tablet hardening, loss of disintegration/de-aggregation properties, etc.)
2.Physical changes in the drug (conversion of a more stable, less readily soluble polymorph, etc.)
3. Chemical changes or interactions involving excipients (such as esterfication of coatings, rendering them less polar and less soluble).
The quality of a drug product depends on the quality of the drug and clinical performance of a drug product also depends on
The rationale of the dosage form design
The method of product manufacture
Procedures adopted for in process quality control and final quality control
Many factors effect the safety, effectiveness and reliability of a drug product. Numerous factors and operative procedures affect the pharmaceutical quality of a drug product. When all these factors are optimized the drug product gives maximum drug reliability and maximum safety. The following diagram shows how many factors at many points influence the quality of a product. All these factors have to be optimized to get an excellent product. This diagram is based on one of the ICH documents, ICH Q8 and was prepared by Mr. Raghunadha Gupta, Research Scholar in AU College of Pharmaceutical Sciences.
So what ICH is trying to do is to give guidance to the industries on how to produce excellent products and also to develop excellent systems to validate these systems. It is about quality assurance. So let us see a brief history of ICH.
The interanational conference on harmonization of technical requirements for registration of pharmaceuticals for human use (ICH) is a project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration.
• Suggest ways to achieve grater harmonization in the interpretation and application of technical guidelines.
• In the requirements for product registration
• To reduce or obviate the need to duplicate the testing carried out during the R&D of new drugs
Result of such harmonization
• More economic use of human, animal and material resources
• Elimination of unnecessary delay in the global development and availability of new medicines
• Maintaining safeguards on quality, safety and efficacy
• Meeting regulatory obligations to protect public health
This mission is embodied in the terms of reference of ICH. ICH is a joint intiative. It involves both regulators and industry as equal partners. They hold scientific and technical discussions of the testing procedures which are required to ensure and assess the safety, quality and efficacy of medicines. There are six parties in ICH. They are the founders of ICH. They are regulatory bodies and research based industries of European Union, Japan. and USA
Observers are WHO, EFTA.
They are non voting members. They act as a link between ICH and non ICH countries and regions.
Operations of ICH are done by
1. ICH steering committee
2. ICH coordinators
3. ICH secretariat
European commission- European Union (EU)
The European Commission represents the 25 members of the EU. The commission is working to achieve a single market in pharmaceuticals which would allow free movement of products through out the EU. The European medicines agency (EMEA) has been established by the commission and is situated in London.
European Federation of Pharmaceutical Industries and Associations (EFPIA)
EFPIA is situated in Brussels and has, as its members, 29 national pharmaceutical industry associations and 45 leading pharmaceutical companies involved in the research.
Ministry of Health, Labour and Welfare, Japan (MHLW)
The ministry of health, labour and welfare has responsibilities for approval of and administration of drugs, medical devices and cosmetics in Japan.
Japan Pharmaceutical Manufacturers Association (JPMA)
JPMA represents 75 members (including 20 foreign affiliates) and 14 committees.
ICH work is coordinated through specialized committiees of industry experts who also participate in the Expert working groups.
US Food and Drug Administration (FDA):
The US Food and Drug Administration has a wide range of responsibilities for drugs, biologicals, medical devices, cosmetics, and radiological products. The largest of the world’s drug regulatory agencies, FDA is responsible for the approval of all drug products used in the USA.
Pharmaceutical Research and Manufacturers Of America (PhRMA)
The Pharmaceutical Research and Manufacturers of America –PhMRA – represents the research based industry in the USA. The association has 67 companies in membership which are involved in the discovery, development and manufacture of prescription medicines. There are also 24 research affiliates which conduct biological research related to the development of drugs and vaccines.
Friends, I think you observe that India is not a member of ICH. Then why are we bothering to learn all about ICH? We are learning because the Indian pharmaceutical industry today is a global industry; it wants to sell its products all over the world; and it has its presence in the form of manufacturing units of generics in many countries all over the world. So we have to know about the standards of the world. We will learn more about pharmaceutical quality, international standards and ICH in my next blog.
1.ICH Topic Q 8 Annex To Note For Guidance On Pharmaceutical Development. European Medicines Agency. (EMEA/CHMP/ICH/518819/2007). December 2008:12/16 http://www.emea.europa.eu/pdfs/human/ich/51881907enfin.pdf