| HHAC
Labor Dr. Heusler GmbH is an independent private laboratory for physico-chemical and
pharmaceutical analysis near Karlsruhe (Germany). HHAC GmbH offers many years' experience
and success in release testing and stability testing of pharmaceutical products. HHAC
GmbH is registered by the relevant German supervisory authority according to paragraph
67,1 AMG as an external laboratory for testing of drugs (paragraph 14,4 AMG). The
laboratory functions under current Good Manufacturing Practices and is being accredited to
DIN EN ISO IEC 17025.
Chemical scientists, chemical engineers and chemical lab assistants with high expertise
in their field and high motivation have been working for clients from the pharmaceutical
industry for 10 years, using state-of-the-art instrumental equipment and facilities.
HHAC GmbH offers support on the following services:
RELEASE TESTING (CHARGE
- CONTROL ANALYSIS)
 | Identity, purity and
content of raw materials
|
| Qualitative and
quantitative determination of active pharmaceutical ingredients and excipients as well as
degradation products and related substances in the finished product
|
| Testing on release
specifications for different drug products: solids, semi-solids, liquids, parentals and
other modern application-forms
|
STABILITY TESTING
| Stability protocol
development according to ICH
|
| Storage of the test
samples under controlled climatic conditions in accordance with ICH guideline
|
| Accelerated stability
test
|
| Testing on run time
specifications
|
BIO-AVAILABILITY /
EQUIVALENCE IN COOPERATION
| Determination of
active pharmaceutical ingredients and their metabolites from biological materials
|
The analytical tests are
carried out according to existing commonly accepted methods, according to pharmacopoeia
(EP, BP, USP) or customer specific test methods.
METHOD DEVELOPMENT AND
VALIDATION FOR:
| Batch release (product
specific methods)
|
| Stability testing
(stability specific methods
|
| Residue testing (e.g.
testing for pesticides, aflatoxines, residual solvents and heavy metals)
|
| Active substance
release
|
| Bioanalysis
(determination of active ingredients and their metabolites from biological material)
|
Validation is executed
in accordance with ICH guidelines (determination of specificity/selectivity, linearity,
range, accuracy, precision, detection limit, quantitation limit, robustness).
The testing and
documentation take place in accordance with GMP standards. You will receive global
reports, testing procedures, statistical analyses and further necessary documents for your
release or marketing authorisation.
The supply is not only
limited to the chemical-analytical service, HHAC GmbH also provides the available
practical/scientific experience to advise you in the connection with marketing
authorisation as well as other general problems of modern analytics and quality assurance.
CONSULTING
Quality management/TQM:
| Assistance in
development and implementation of a QM-system
|
| Audits
|
Marketing
authorisation/registration:
| Application for
marketing authorisation and response to deficiency reports
|
| Documentation and
expertise in accordance with notice to applicants
|
| Literature research
|
A substantial part of
our firm philosophy is not just to handle orders but to look for integrated,
target-oriented solutions together with the customers.
The quality management
system provides traceability, correctness and plausibility of the determined analysis
results and vouches for professional and reliable handling and continuous high quality.
While collaborating
successfully with our industry partners, HHAC GmbH works on a high level of quality in
analytical testing services with high flexibility and just-in-time service. HHAC GmbH
offers an individual customer care with consideration of their specific needs, continuing
dialogue between the partners by competent staff
HHAC LABOR DR.HEUSLER
GMBH
Postfach 1457
D-76293 Stutensee
Germany
Tel: +49 7249 9130 20
Fax: +49 72 499 130 299
E-mail: hhac@hhac.de
|
 |
Dr. Hermann Heusler,
Managing Director |
