Analyses made in Germany
More than 45 years of experience in GMP analyses made in Germany
Over time, regulatory requirements have evolved. We have kept up and evolved with them. As a result, we are proud of the quality system as it is today. We look forward to the challenges of the future and will continue to develop the system in the spirit of continuous improvement.
The two laboratory sites have grown and improved over more than 45 years. One of the major milestones in recent years has been the relocation and simultaneous merger of the two laboratory sites near Munich. We are delighted to have been operating at the new site in Neuried for more than two years and to continue our story at this site.
Laboratory Information & Management System (LIMS)
A LIMS database is used to register and manage samples, references, instruments, sample results and processes such as OOS or deviation procedures. The latest innovation in this area is the use of smart labels, which can indicate in real time whether an instrument has been approved for analyses. These smart labels are controlled via the LIMS. In addition, automated results reports (CoA, RoA) can be generated using the system. This ensures consistent reporting of your results.
Chromatography
Centralized software capable of running all chromatography instruments. It is used to control the chromatography systems and evaluate the data collected. The software is validated and Part 11 compliant. The software always uses the same algorithms to determine a peak, regardless of the instrument used.
Laboratory documentation
Laboratory reports are automatically issued and tracked by the LIMS. Weighing documentation is digital and includes an audit trail entry. The software for weighing is Part 11 compliant. Thankfully, the days of weighing print outs are over.
Harmonized processes at both laboratory sites - the same SOPs in the main processes apply
The two GMP laboratory sites in Ulm and Neuried have a harmonized Quality Assurance system. The main processes are harmonized and the same documents apply at both sites. The training courses are centrally controlled and monitored by a Quality Management team. This ensures that you receive the same quality at both locations. If the measurement technology is available at both sites, then the two laboratories are interchangeable or, in other words, redundant.
Harmonized core processes:
• OOS / OOE
• Deviation
• Corrective and Prevantive Action (CAPA)
• Change Control
• Risk assessment
• Data Integrity
• LIMS
• Chromatography software
• Software for titrators and balances
• Cutting and rounding of values
• Audits
• Qualification of Instruments
• Validation of analytical methods
• Analytical method transfer
• Verification
• Supplier qualification and subcontraction
• Document management system
• Complaint
• and a whole lot more
About GBA Group - GMP Labs
We are continuously working on the automated evaluation and reporting of results. Our goal is to become a ‘paperless’ laboratory.
We look forward to welcoming you as our client.
Quality Standard
• GMP AMWHV §14 (EU GMP Guideline and respective German implementation)
• cGMP (21CFR 210 and 211)
• GMP AMWHV §13 (EU GMP Guideline and respective German implementation)
• non-GMP
For a more detailed information about the GBA Group GMP testing sites please click here.
What types of materials are most commonly analyzed under GMP by GBA Group?
• API
• FDF (e. g. tablet, creme, syrup, suppository, pellets…)
• Excipients
• Packing material
• Ingredients
• Additives
• others
European Pharmacopoeia and United States Pharmacopeia
We have a high level of expertise in the testing of parameters such as:
Dissolution and Disintegration
Ph. Eur. chapter
2.9.3. Dissolution test for solid dosage forms
2.9.42. Dissolution test for lipophilic solid dosage forms
2.9.43. Apparent dissolution
ICH Q4B Annex 7R2
2.9.1. Disintegration of tablets and capsules
2.9.2. Disintegration test for solid rectal and vaginal dosage forms
USP / NF chapter
〈711〉 Dissolution
ICH Q4B Annex 7R2
〈701〉 Disintegration
Particulate Contamination and Particle Size Distribution
Ph. Eur. chapter
2.9.20. Particulate contamination: visible particles
2.9.19. Particulate contamination: sub-visible particles
2.9.31. Particle size analysis by laser light diffraction
USP / NF chapter
〈790〉 Visible Particulates in Injections
〈788〉 Particulate Matter in Injections
〈429〉 Light Diffraction Measurement of Particle Size
Identification
Ph. Eur. chapter
2.2.24. Absorption Spectrophotometry, Infrared
2.3.1. Identification reactions of ions and functional groups
USP / NF chapter
〈197〉 Spectroscopic Identification Tests
〈191〉 Identification Tests—General
Appearance of solution
Ph. Eur. chapter
2.2.1. Clarity and degree of opalescence of liquids
2.2.2. Degree of coloration of liquids
USP / NF chapter
〈630〉 Visual Comparison
〈855〉 Nephelometry and Turbidimetry
Assay Tests
Ph. Eur. chapter
e. g.
2.5.1. Acid value
2.5.3. Hydroxyl value
2.5.6. Saponification value
2.5.11. Complexometric titrations
2.5.12. Water: semi-micro determination
2.5.32. Water: micro determination
2.5.29. Sulfur dioxide
2.5.30. Oxidising substances
2.5.33. Total Protein e. g. Bradford, Lowry
USP / NF chapter
e. g.
〈921〉 Water Determination
〈401〉 Fats and Fixed Oils
〈525〉 Sulfur Dioxide
〈507〉 Protein Determination Procedures e. g. Bradford, Lowry
Gravimetric Test
Ph. Eur. chapter
2.2.32. Loss on drying
USP / NF chapter
〈731〉 Loss on Drying
Limit Tests
Ph. Eur. chapter
e. g.
2.4.3. Calcium
2.4.4. Chlorides
2.4.6. Magnesium
2.4.8. Heavy metals
2.4.9. Iron
2.4.13. Sulfates
2.4.14. Sulfated ash
2.4.16. Total ash
Acidity or alkalinity reducing substances
USP / NF chapter
e. g.
〈281〉 Residue on Ignition
〈221〉 Chloride and Sulfate
〈231〉 Heavy Metals
Other Tests
Ph. Eur. chapter
e. g.
2.9.5. Uniformity of mass of single-dose preparations
2.9.40. Uniformity of dosage units
2.2.9. Capillary viscometer method
2.2.10. Viscosity -Rotating viscometer method
2.2.5. Relative density
2.2.6. Refractive index
2.2.20. Potentiometric titration
2.9.8. Resistance to crushing of tablets
2.2.7. Optical rotation (specific optical rotation)
2.8.4. Swelling index
2.2.35. Osmolality
2.9.39. Water-solid Interactions: determination of sorption-desorption isotherms and of water activity
USP / NF chapter
e. g.
〈905〉 Uniformity of Dosage Units
〈1911〉 Rheometry
〈841〉 Specific Gravity
〈831〉 Refractive Index
〈541〉 Titrimetry
〈1217〉 Tablet Breaking Force
〈781〉 Optical Rotation
Swell Volume
〈785〉 Osmolality and Osmolarity
〈922〉 Water Activity
Packaging Material Testing
- Glass Containers (Ph.Eur. 3.2.1 / USP <660>)
- Plastic Materials and Containers (Ph.Eur. 3.2.3 to 3.2.6 / USP <661>, <671>)
- Rubber Seals (3.2.9 / <381>)
- Silicon Elastomers (3.1.9)
- Container Closure Integrity Tests (CCIT)
- Extractables & Leachables Studies
Instrumentation Analyses
Instruments for qualitative and quantitative approaches:
• Assay
• Limit Tests
• Related substances
• Residual solvents
Instrumentation Details
HPLC:
- VWD / DAD
- Refraction index
- ECD (electrochemical)
- CDD (conductivity)
- CAD (charged aerosol)
- FLD (fluorescence)
UHPLC:
- MS
- VWD / DAD
- CAD (charged aerosol)
- FLD (fluorescence)
GC:
- Head-space
- direct
- FID
- MS
Spectroscopy:
- ICP-MS
- ICP-OES
- AAS / AES (hybrid system)
- Microwave digestion available
Potentiometric Titration:
- several electrodes available
Limit Tests and Assays
Elemental impurities / Screening
- 2.4.20. Determination of elemental impurities
- 〈232〉 Elemental Impurities—Limits
- ICH Q3D
Composition of fatty acids
- 2.4.22. Composition of fatty acids by gas chromatography
- 〈401〉 Fats and Fixed Oils
Residual solvents
- 2.4.24. Identification and control of residual solvents
- 〈467〉 Residual Solvents
- 〈1467〉 Residual Solvents—Verification Of Compendial Procedures And Validation Of Alternative Procedures
- 2.4.25. Ethylene oxide and dioxan
- 〈228〉 Ethylene Oxide and Dioxane
- 〈469〉 Ethylene Glycol, Diethylene Glycol, and Triethylene Glycol in Ethoxylated Substances
- untargeted screening
Uniformity of dosage units
- 2.9.6. Uniformity of content of single-dose preparations
- 2.9.40. Uniformity of dosage units
- 〈905〉 Uniformity of Dosage Units
Microbial contamination
Our GBA Group site located in Ulm (Germany) offer microbiological tests.
Learn more about our microbiological tests here.
Stability Testing - Comprehensive Service
In the field of stability testing, we offer a comprehensive service for human and veterinary medicinal products as well as for medical devices.
Our service includes consulting and planning of your stability studies as well as all necessary testing and quality assessments.
• Storage of your samples under the required conditions (e.g. ICH conditions and special conditions)
• Stability study sample management
• Perform the pre-planned analyses on stability samples as scheduled
Learn more about our Stability Testing Services here.
