Quality management


Quality management as a common thread

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:

  • through inspections by the responsible authorities,

  • monitoring by the accreditation body and

  • numerous on site audits of our customers

as well as internally

  • through regular participation in interlaboratory comparisons,

  • performance of interlaboratory comparisons, and

  • laboratory audits by external assessors.

It covers all areas in our company:

  • Administration

  • Personnel

  • Rooms and equipment

  • Control and management of documents

  • Creation and management of records

  • Data integrity

  • Archive

  • Quality risk management

  • Risk and opportunity management

  • Continuous improvement

  • Qualification, calibration and maintenance

  • Validation

  • Change control

  • Corrective and preventive actions (CAPA)

  • Inspections

  • Safety, occupational health, environmental aspects

  • IT

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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:

  • Manufacturing authorization for human pharmaceuticals

  • Manufacturing authorization for veterinary medicinal products

  • GMP certificate for medicinal products for human use or investigational medicinal products for human use

  • GMP certificate for veterinary medicinal products

QP certification
On request, we offer the certification for both human and veterinary medicinal products by our Qualified Person.


Quality management system

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:

  • Company policy (part 0)

  • QM elements (part QMM [Quality management manual])

  • Standard Operating Procedures (part SOP)

  • Test methods (part TM)

The individual parts are composed as follows:

Part 0

  • Company portrait with a description of the field of activity

  • Statement of company and quality policy

  • Business continuity plan

  • Complete list of all documents of the QM manual

Part QMM

  • Overview of the structure and process organization of the testing laboratory

  • Realization of quality planning, control, assurance, and improvement in all work processes described

  • Reference to standard operating procedures applicable in each case

Part SOP

  • General standard operating procedures

  • Equipment SOPs

  • Forms

Part TM

  • Own and client-specified test procedures with the detailed description of each individual method

Quality risk

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.

Risk and opportunity management

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 policy

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.

Continuing education and training

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!