Analytical | Microbiology | Stability | Validation Services | Quality Services
We provide full service Quality Assurance/Quality Control capability. Analytical and microbiological laboratories provide raw material, packaging component, chemical intermediate and finished product testing services to the production operation. Our Stability Services group provides sample storage, full testing, statistical analysis and report writing capability to customers who need support up to and including the requirements of ICH. Our Quality Systems organization provides validation, change control, production support, documentation control, and other cGMP services to the plant and to our customers.
We can also provide lab support services on a contract basis and, in fact, are already doing so for multiple customers. The product or compound being tested need not have been manufactured at our facility.
Analytical
The Analytical laboratory provides raw material, packaging component,
chemical intermediate and finished product testing services to the production
operation.
Services
- HPLC/GC testing
- Analytical and vibrational spectroscopy.
- Wet chemical analysis.
- Compendial procedures such as USP, EP and JP requirements.
- Method development and optimization for most chromatographic and spectrophotometric methods.
- USP Apparatus I and Apparatus II dissolution testing.
Microbiology
The Microbiology lab at Norwich is equipped to perform a variety of
microbiological services to support the pharmaceutical, biotech and consumer
product fields. The ELAP-certified Microbiology laboratory also performs
periodic monitoring of the manufacturing environment and plant utilities.
In addition to the services listed below, the micro lab conducts investigations
and provides sampling, training, identifications, validation and method
development services.
Services
- Microbial limits testing to meet USP and EP requirements
- Preservative effectiveness testing
- Cleaning validation and environmental monitoring
- Potable and purified water testing
- Sterility testing
Stability
The Stability laboratory performs testing required to support package
and bulk product stability programs. To ensure the complete accuracy of
our results, stability chamber conditions are monitored 24 hours a day
using the Kaye Labwatch system.
Services
- Stability studies and testing for ICH storage conditions and WHO long-term storage conditions for climactic zone IV (30C/70%).
- Full stability data evaluation, including statistical evaluation of quantitative data.
- Stability tests based on FDA mandates.
- Report writing and data compilation for technical progress reporting, GMP reviews and for submission-ready regulatory reports and modules.
- Consulting on stability requirements for product development and post approval changes and variations.
Methods
- Analytical capabilities include: HPLC, gas chromatography, TLC, dissolution, UV-Vis and fluorescence spectroscopy, atomic absorption spectroscopy and infrared spectroscopy.
- Statistical analysis using SAS® software and FDA and European-recognized techniques for analysis of stability data.
Validation Services
We have an extensive validation program with services
including IQ, OQ, PQ, Cleaning Validation and Master Plan development.
Our dedicated teams assure that every protocol meets all regulatory expectations
and current industry standards. Once the equipment and processes are validated,
a comprehensive change control program assures that the validated state
is maintained.
Quality Systems
Our
experienced staff supports all daily production for our customers. We
can also incorporate customer quality systems into our operation or assist
in their development. Quality systems include:
- Batch record development and management
- Specification development and management
- Change Control
- Annual Product Reviews
- Complaint Investigation and Response
- Regulatory Audit Preparation and Response
