GMP Inspection Process World Health Organization 2 January, 2019 Introduction Good morning and welcome to all of you to this part of the training course offered by the World Health Organization. The training course is designed to develop the practical implementation of the WHO texts of Good Manufacturing Practices for pharmaceutical products, and provisional guidelines on the inspection of pharmaceutical manufacturers. A special word of thanks to ________________________for the arrangements that have been made to accommodate us all for the duration of the programme (insert names and organisation, as appropriate). My name is ___________________________________________________ During the last couple of days, we looked specifically at the basic principles of Good Manufacturing Practices, for the manufacture of pharmaceutical products. (Draw attention to fire/emergency procedures and cover all domestic arrangements, including the location of toilet facilities.) Presentation 15 - 30 minutes

World Health Organization Introduction World Health Organization 2 January, 2019 Programme Objectives 1. Training in the WHO GMP text on inspection 2. Training in using your experience 3. Developing your own action plan These are the objectives that we have for this programme: 1. We aim to provide you with training to ensure that you have an understanding of all aspects of the WHO guidelines on the inspection of pharmaceutical manufacturers. The programme is designed and developed in such a way that your input is important throughout the training. 2. Therefor the programme has been designed to enable you to bring in your real life inspection experiences, so that we can share knowledge and explore ways to respond to these challenges. 3. A training programme is only of value if, as a result of the training, you can change your behaviour by implementing aspects that may have been lacking in the past. To encourage such a change, you could prepare your own personal action plan as we work through the course. You will be expected to discuss this action plan with your supervisor on your return to office, and then at regular intervals thereafter, to review your progress with him or her over the next few months.

World Health Organization Inspection World Health Organization 2 January, 2019 Programme Overview Introduction The fundamentals of inspection the role of the inspector preparing for inspections the inspection process Types of inspection During the next few sessions, we shall be looking at the provisional guidelines on the inspection of pharmaceutical manufacturers, and recommendations that can assist you during the inspection. We are working through the introduction now. We shall be looking at some of the fundamentals of the inspection. We will have modules on the role of the inspector, preparing for an inspection, and the process of conducting an inspection, including issuing a report. We will also be looking at the different types of inspections (as defined in the WHO text). that you are likely to carry out, and any specific issues facing you as inspectors in this country. Where possible, we will be using the experience that we all have to find ways to overcome the problems, you are likely to encounter

World Health Organization Introduction World Health Organization 2 January, 2019 Guidelines to promote harmonization directed to government inspectors small regulatory authorities assist in assessing GMP compliance value to manufacturers self-inspection The guidelines in the WHO text are intended to promote the harmonization of pharmaceutical inspection practices among WHO Member States. Non member states can also adopt the same principles. The guidelines are directed to government inspectors, particularly those operating in small regulatory authorities. These will also assist inspectors when assessing manufacturer’s compliance with good manufacturing practices. The guidelines are also of value to manufacturers as these provide assistance to manufacturers when they perform self-inspections.

World Health Organization Inspection World Health Organization 2 January, 2019 Cover production and control final dosage forms human and veterinary use drug substances API and bulk drug substances Same fundamental principles pharmaceutical products biological products medical devices diagnostic products The guidelines cover the inspection of production and control of final dosage forms; not only pharmaceutical products for human use, but also products destined for veterinary use. The guidelines also cover drug substances such as active pharmaceutical ingredients (APIs) or bulk drug substances. The same fundamental principles apply in all cases of inspection of the production and control of products, including pharmaceutical products, biological products, medical devices and diagnostic products and even foods.

World Health Organization Inspection World Health Organization 2 January, 2019 Inspection and licensing vital element of drug control WHO Certification Scheme on the Quality of Pharmaceutical Products moving in International Commerce One of the vital elements of drug control, is inspection and licencing of pharmaceutical manufacturing facilities. This is done on the basis of assessment of compliance with good manufacturing practice. Inspection and licensing are also pivotal to the operation of the WHO certification scheme on the Quality of Pharmaceutical Products moving in International Commerce. This means that the competent authority in the exporting country attests that a product manufactured for export, is manufactured in premises, and using procedures, that are in compliance with GMP

World Health Organization Inspection World Health Organization 2 January, 2019 Other contexts self-inspection of the company independent inspection by persons from, e.g. International Organization for Standardization (ISO) audit by authorized agents of a customer The provisional guidelines on the inspection of pharmaceutical manufacturers also have relevance in various contexts, including: Self-inspection or internal audit of a factory or a part of it carried out by personnel of the company. Inspection by an independent person or group of persons as a review of the quality system of a company in compliance with the standards issues by the International Organization for Standardization. Audit of manufacturer or supplier by authorized agent of the customer.

World Health Organization Inspection World Health Organization 2 January, 2019 Inspectorate enforcement arm of the national drug regulatory authority (DRA) Functions ensure adherence to licensing provisions adherence to GMP Objectives control and enforce standards through sequential examination (production and control) recommend authorization of manufacture of pharmaceutical products verification of performance verification of data The inspectorate represents the enforcement arm of the national drug regulatory authority. Some of the functions of the inspectorate include activities to ensure that manufacturers comply with the conditions and provisions of the manufacturing and marketing licenses, and to ensure that the manufacturers comply with good manufacturing practices. One of the objectives of the inspectorate is to control and enforce the general standards of production. Through sequential examination of production and control activities of the manufacturer, the inspectorate authorizes the manufacture of pharmaceutical products to manufacture pharmaceutical products. During inspections, the inspectorate verifies the performance of manufacture of products and verifies the data submitted in the relevant licensing application. Trainers should note, that in some countries inspectors recommend the authorization of manufacturing licenses to the National Drug Regulatory Authority