Eclipse Scientific Group
 Ely Laboratory

 

 

 


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PHARMACEUTICAL VALIDATION

Method development and validation

Methods tailored to best suit particular products and the monitoring of their performance can be developed, validated and reported under ICH Guidelines.

An experienced member of staff, appointed as the Study Director will:

discuss your requirements

suggest the most appropriate and cost effective testing protocol

oversee the testing programme

prepare the final report

The final report, fully explained to the client by the Study Director, will include:

full method details

results obtained

graphical representations of data

calculation protocols

validation data, including specificity, applicable range, accuracy, precision, limits of detection

Clients’ own methods (eg for monitoring indices of stability) can be validated or even upgraded to comply with ICH guidelines.

Methods can be developed for use in GMP compliant environments e.g. Quality Control and to support transfer of production between sites.

Testing for residual solvents, physical testing and the development of microbiological methods are also available.

Pharmaceutical Validation


Eclipse Scientific Group
2 Bartholomews Walk 
Cambridgeshire Business Park 
Ely 
Cambridgeshire CB7 4ZE

Tel: 0845 2309910
Fax: 01353 660050 
International:
0044 1353 660040

email:enquiries@esglabs.co.uk

Pharmaceutical testing and analysis

Recent news
The state of VALIDATION in the European Union
When the same manufacturer markets its pharmaceutical products to consumers in other EU member states, the regulatory directives of the European Commission and the European Agency for the Evaluation of Medicinal Products (EMEA) apply as well.
Source: pharmatech, Date and Time of entry: 09 April 2006 11:59

An Overview - Abstract from African Journals Online
An Overview of Pharmaceutical VALIDATION and Process Controls in Drug Development.
Source: journals , Date and Time of entry: 09 April 2006 11:55

Validating Pharmaceutical Systems
Validating Pharmaceutical Systems: Good Computer Practice in Life Science Manufacturing delineates GCP, GLP, and GMP regulatory requirements and provides guidance from seasoned practitioners on how to fulfill them. John Andrews and his team tackle the perceived complexities surrounding the VALIDATION of a wide variety of automated systems.
Source: piribo, Date and Time of entry: 09 April 2006 11:46

Pharmaceutical VALIDATION and Process Controls in Drug Development
It has always been known that facilities and processes involved in pharmaceutical production impact significantly on the quality of the products. The processes include raw material and equipment inspections as well as in-process controls. Process controls are mandatory in good manufacturing practice (GMP).
Source: bioline, Date and Time of entry: 09 April 2006 11:42

Should you require further information and costs of our pharmaceutical tests, please contact us.

 

 
 
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