Quality Management Principles In ICH Q7
Marie F. Morine experienced former US FDA Drug Specialist investigator with a demonstrated history of working extensively in the pharmaceuticals industry in the US and multiple other countries including China, India, Germany, Italy, Austria, Ireland, France, the UK, and the Netherlands to name a few.
Now putting those skills to work as the owner of her own consulting firm providing insight into the workings of the US FDA through training in person and in Webinars, conducting Mock FDA audits, advising on facility set up and layouts and advising on the preparation of responses to FDA-483's and Warning Letters.
Skilled at auditing a wide variety of manufacturers of: Sterile and non-sterile API's, Sterile and Non-Sterile Finished products, Immediate release, Extended-release, and Timed release Capsules and Tablets, Good Laboratory Practice (GMP) Labs, Good Laboratory Practice (GLP) Lab facilities, Biologically produced APIs and Finished Products and Medical Device manufacturers. With wide experience evaluating and improving documentation in relation to Change Control, Deviations, Complaints, Investigations, and CAPA as well as laboratory documents, raw data, and OOS investigations. Well versed in Pharmaceutical, Biotechnology, and Regulatory Requirements. Strong business development professional with a BS focused in Health Sciences w/ 50 hr Microbiology concentration from East Tennessee State University.
We will go over each principle described in ICH Q7, determine the meaning and exactly what to do to be in compliance. The principles that will be covered include
- Who is responsible for the quality
- Participation of management
- Defining and documenting all quality related activities
- The independence of the quality unit
- The need to specify specific individuals for certain tasks
- Contemporaneous recording of quality related activities
- Evaluation of raw materials before use
- Procedures for notifying management of issues or regulatory inspections
Course Level - This is a basic to intermediate level presentation. Informing at the basic level and a good review at the intermediate level.
Who Should Attend
All levels of persons working in the Quality Unit, including Quality Assurance and Quality Control.
Why Should Attend
Year after year the most frequent observations from US FDA cite issues with the Quality System. Some of the most frequent observations cite a Quality Unit that is not independent of Production, ineffective due to a lack of authority and understaffed. These are just 3 of the 9 principles of Quality Management listed in ICH Q7, that we will be going over in this presentation.
These principles seem to either be poorly understood or poorly implemented in many companies since they are the source of so many observations on US FDA-483’s every year. The purpose of this presentation is to describe each of these principles and explain specifically what FDA is looking for when determining compliance with each of them.
Although these principles are listed in ICH Q7, which applies specifically to the production of API’s, these principles apply to all manufacturers of Pharmaceuticals including Finished Dosage forms.