We offer our clients a wide range of scientific and advisory services in the field of solving problems in modern pharmacy and laboratory research. The vast experience and scientific knowledge of our employees guarantees the highest level of services.
CTO – Contract Testing Organisation
In response to the challenges posed to the Quality Control departments of pharmaceutical companies, we have created a service to transfer part of the volume of release testing of manufacturing companies to our laboratory.
Advantages of contracting at MT Laboratories:
Services are provided by an experienced and carefully selected analytical team
Greater resilience of the Principal to migrations and access to analytical staff
Greater resilience of the Principal to sudden increases in demand and consequent increases in production plans
Increased possibility to optimise the efficiency of the QC department on the Principal's side (by transferring the methods required to an external laboratory), consequently improving the indicators (Number of batches tested per analyst, Right First Time, improvement of OOT/OOE/OOS indicators)
Possibility of precise planning of analytical reserves on the part of the ordering party
Same or slightly higher cost per batch compared to the cost of testing at the commissioning party
Guarantee of punctuality
Cost-free verification of analytical methods and their transfer under contract *
As part of the service, we offer GMP-standard testing with a certificate confirming the manufacturing stage carried out at MT Laboratories.
If interested, please email contact@mtlab.pl or call +48 577 677 444.
* for an order of at least 10 batches/month
GMP testing
We offer a full range of physico-chemical tests for raw materials, semi-finished products and finished products. We have the appropriate equipment and skills to conduct efficient and reliable research for API, drugs, dietary supplements or cosmetic products, regardless of the form in which they appear (ointments, creams, syrups, tablets, capsules, etc.). Depending on the client's needs, we perform analysis in accordance with the GMP system or the internal quality management system. We carry out analyzes using the classical methods of wet chemistry analysis and advanced analytical techniques such as HPLC, GC and LC-MS.
Some examples of analysis from our offer are presented below:
Determining active substance in the final product - Confirming the identity of products, raw materials, API
The test for Content Uniformity
Identification of known and unknown impurities in the product
Drug release
The release profiles
Determination of water content using the Karl Fischer electrometric titration method
The disintegration tests
Tablet hardness tests
For detailed information on the scope and research method carried out by our team, please contact us directly.
R&D testing
We provide services in the field of development, validation and transfer of research methods. This applies to research methods for drugs and dietary supplements as well as methods used to assess the effectiveness of hygiene of machinery and production equipment. We provide services according to the ICH guidelines (International Conference on Harmonization), The European Medicines Agency's and the FDA (American Food and Drug Administration) guidelines. In addition, we offer employee training in the field of working with the method that is the subject of validation.
Training
Our offer includes a wide range of training courses that provides the trainee with the required skills and knowledge necessary to work in the pharmaceutical, food and dietary supplement industries. Based on the knowledge and experience of our employees, we are able to conduct professional training courses based on theory and practice, including the following issues:
High performance liquid chromatography - HPLC (laboratory training courses) - Gas chromatography - GC (laboratory training courses)
Validation of research methods (workshops)
Transfer of research methods (workshops)
GMP and GLP - implementation, accreditation, preparation for inspection (workshops)
Optimization of work and laboratory management (laboratory training courses)
Internal / external auditor
Consulting
High performance liquid chromatography - HPLC (laboratory course)
Gas chromatography - GC (laboratory course)
Validation of research methods (workshop)
GMP and GLP - implementation, accreditation, preparation for inspection (workshops)
Laboratory optimization and management (laboratory course)
Internal / external auditor
Audits
We conduct tests in terms of compliance with specific standards, patterns, checklists, legal regulations, norms or internal regulations e.g. of pharmaceutical companies for excipients and API. Our employees have relevant experience in working in a GMP as well as audit certificates for integrated ISO quality systems.