API International Training Programme

The International API Training Programme (API ITP) consists of 3 segments related to the PIC/S GMP Guide, Part II (ICH Q7). The segments include (i) General Training on ICH Q7, which is open to Regulators and industry; (ii) Advanced Training which is open to Regulators only and (iii) Q&A for Regulators and industry. The API ITP is led by the PIC/S Expert Circle on API.

PIC/S - PDA ICH Q7 Training, Ahmedabad (India), 2015 

 Lecture’s attitude for questions was very nice. Also, I feel they are real experts!

Participant, PIC/S - PDA ICH Q7 Training, Seoul (Republic of Korea), 2015

Key Features

The International API Training Programme (API ITP) was developed by the PIC/S Expert Circle on API. This training programme was established at the request of a number of National Medicines Regulatory Authorities. The objective of the programme is to raise GMP awareness amongst Inspectorates, Inspectors and industry in relation to API manufacture as well as their supply chain and the harmonisation of the application of ICH Q7 (PIC/S GMP Guide, Part II) to the inspection of API manufacturers.

The API ITP is also intended to provide an update as well as training on current issues and future challenges for API inspections such as International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) documents related to quality topics (Q8, Q9, Q10, Q11) and supply chain (falsification/ adulteration) issues.

The objectives of the three segments of the API ITP related to PIC/S GMP Guide, Part II (ICH Q7) are:

API ITP General Training
 

API ITP General Training is elaborated by Regulators and industry for Regulators and industry. It aims at delivering ICH Q7 guidance training at a global level in several locations around the world, in particular in key regions of API manufacturing. Given that there were a number of Professional Associations which already had training material on this topic, collaboration was sought with one or more of these associations to review, revise and deliver training. The Parenteral Drug Association (PDA) was identified.

The General Training material covers all ICH Q7 sections with specific additions on Q7 technical related-technical topics such as data integrity, supplier qualification, starter material, EU Falsified Medicines Directive (FMD). Inspection techniques are only discussed as part of the Advanced Training for Inspectors only (Expert Circle meetings). 

API ITP General Trainings have taken place in:

The courses which took place in 2015 were organised with the financial support of the European Commission.

API ITP Advanced Training

API ITP Advanced Training is elaborated by Regulators and for some parts by industry, for Regulators only. It aims at delivering advanced training during API Expert Circle meetings in order to meet the challenges arising through regulation of the global API production and supply chain. Advanced Training has taken place within the frame of the following Expert Circle on API Meetings:

 
API ITP Questions & Answers

The API ITP Q&A is a series of questions and answers elaborated by Regulators, for Regulators and industry. The outcome from PIC/S was transferred to ICH as contribution to the ICH Q7 Questions & Answers on Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, which was published in June 2016.

The outcome of the PIC/S Q&A will also be incorporated into the training materials developed in the frame of the General Training and Advanced Training.

Upcoming PIC/S - PDA ICH Q7 Training

Q7 training activities are open to Inspectors from PIC/S Participating Authorities, (Pre-)Applicants, Partners and Non-Member National Medicines Regulatory Authorities as well as Industry.

Upcoming Q7 training activities are announced under Training Calendar.

Training Materials

API ITP training materials are available under Materials. Login is required.