Structure of the Quality Management Manual
HHAC has laid down the basic principles of its quality management system in a manual. Its structure is hierarchical and divided into the following sections:
The individual parts are composed as follows:
Part 0
Part QMM
Part SOP
Part TM
A systematically implemented quality risk management bundles processes for the identification, control, and communication of risks, especially of products. HHAC has implemented quality risk management process structures in all GMP-relevant areas.
This includes risk assessments regarding the quality of analytical results and other services.
HHAC continuously monitors its risks and opportunities. The aim is to ensure that we are as well prepared as possible for future changes in the market. In this way, risks threatening the company’s existence have to be identified at an early stage, and new opportunities that arise are to be exploited systematically in order to secure the company’s continued existence in the long term. Although responsibility for risk management lies within company management, we endeavor to raise awareness of risks and opportunities in our company among all employees.
Meetings are organized by management on a regular basis, at which all relevant factors in the company are considered and evaluated. All risks and opportunities identifiable to us, including probability of occurrence and potential consequences, are listed and decisions are made on the measures to be taken in response. We continue this process on an ongoing basis and review it for changes.
Qualification and validation are elementary components of the HHAC quality management system. They ensure that the procedures used for quality control are fit for their purpose and that the analytical results and results of further services are valid. It is important to ensure that the qualifications and validations of the systems and procedures retain their validity throughout the entire life cycle. Maintenance and calibration are among the key measures to maintain qualification.
HHAC checks at regular intervals whether the systems and processes are still in a qualified or validated state. Corresponding inspection intervals are specified in the QMM documents.
In order to keep our knowledge up to date and to meet the associated requirements, we regularly offer our employees further education and training opportunities. This also includes recurring QM trainings!
GMP
We are licensed as an external laboratory for the testing of medicinal products according to §67,1 AMG. Thus we are subject to supervision by the responsible authority, the Regierungspräsidium Tübingen. The following certificates can be sent upon request:
QP certification
On request, we offer the certification for both human and veterinary medicinal products by our Qualified Person.
HHAC operates a comprehensive quality management system (QMS). This is based on the specifications of GMP and the requirements of the DIN EN ISO/IEC 17025:2018 standard. Our QMS is regularly reviewed:
as well as internally
It covers all areas in our company: