Focus on Quality

 

Chemika seeks to solve analytical problems through the use of sound science and technology. A scientific approach to compliance usually leads to the most workable and economical solution, and also the solution which has the greatest chance of acceptance by regulators.

Chemika is regulated by both the TGA & APVMA in Australia and works under a variety of international regulatory quality frameworks. Our team offers experience crossing a multitude of international boundaries, enhancing Chemika’s practical experience in dealing with international requirements. Our breadth of experience brings added security when negotiating international analytical data requirements. 


Our purpose built facility is designed to facilitate efficient workflow, meeting stringent quality controls. Our commitment to quality extends beyond the bricks and mortar of the laboratory to high quality systems and processes, facilitated by our Quality Control Department.

Standard operating procedures

As a contract chemical testing laboratory it is imperative that we have robust quality systems in place. Our Quality Department, led by Darren Fearey, ensure that our SOPs remain relevant and are adhered to by our staff, through ongoing training and a commitment to quality.

Training

At Chemika we are committed to the ongoing development of all our employees. Our training program begins at Day 1 of the induction of a new team member and is a continuous process. We have a strong commitment to the success of all our employees through our Professional Development Program.  Our strong commitment to training benefits all stakeholders, underpinned by our commitment to safety, understanding Standard Operating Procedures and continuous professional development.

GMP agreements

A contract testing agreement is a type of GMP agreement which is in place between a client and a contract laboratory.
It details the responsibilities of both parties and describes how the testing will take place.

– Where it will be carried out (address)
– Carried out in compliance with code of GMP
– Retention of records and retention samples
– Method validation and verification
– Confidentiality

Should a GMP agreement cover commercial conditions or pricing?

Consider very carefully how clauses in a GMP agreement will be implemented.
GMP agreements are different to SOP’s and test methods.

– Individual GMP agreements are not presented to analysts as part of their training.
– GMP agreements are not routinely referred to by analysts when undertaking testing.

Clauses in GMP agreements can only be implemented in a contract laboratory via SOP’s and test methods.

A GMP agreement will contain clauses stating that the testing must be carried out in compliance with the Code of GMP.
Specific clauses about aspects of GMP compliance should not be required in a GMP agreement.
The manner in which this compliance is achieved is best evaluated during an audit.

Audit … Regulators and Clients


On site GMP audit of external laboratories is the most common method of investigating their competence.
The GMP audit is effective but has some disadvantages:

–Resource intensive – on the date of audit plus ensuing correspondence.

–Point in time view.

–Because of the time requirements, notice is necessary.

–Expertise may not exist in the client organisation.

–Catch 22, “chicken in egg” problem for new labs: How can you audit effectively before a lab does any work for you?


Other approaches can be used to complement GMP audits, resulting in a more planned approach than “incident management”.

  • Paper audit.
  • Incidental visit


Paper Audit:

  • Can be carried out at any point in time without notice.
  • Useful for a new service provider.
  • Review of incidents or review of typical results.
  • Less resources.
  • Focussed on the testing which is being subcontracted.


Paper audit consists of:

  • Review of raw data – worksheets and instrumental output.
  • Can be extended to include calibration, standards and other aspects of testing.


The introduction of independent auditors has heralded a change in the way many of our clients consider the auditing process. By employing an independent auditor your time is freed and in many cases the experience is cheaper as the auditor is often able to share the burden of cost, across a number of manufacturers. Of course confidentiality is always strictly adhered to.

Security and controls...

With all chemical testing undertaken by Chemika we guarantee three essential parts of control testing:

Accountability and transparency: Chemika is committed to allowing clients full access to test data for any analysis conducted for that client.

Analytical run validation: All instrumental methods will include run validation every time the analysis is performed. For chromatographic methods, this typically includes determining the %RSD of six standard injections, and the preparation of a duplicate standard to verify calibration. The only time this is not conducted is where alternative performance testing is included in the test method.

Confidentiality: All information pertaining to test results or product composition are maintained as strictly confidential. It is also not disclosed which organisations use Chemika without the written permission of the client.

 

Out of Specification Results

Control of retesting and revision of results is critical to the integrity of data generated by a laboratory. Sound retest protocols prevent the possibility that out of specification product is released for sale due to an ad-hoc analytical review or retest procedure. Chemika understands release of out of specification product can result in large costs of recall and possible risks to consumers. Test investigation procedures at Chemika are aimed at gathering data which allows the evaluation of results using sound scientific reasoning, resulting in either revision of the result or confirmation of initial testing.

A good working relationship with an external laboratory is an asset to an organisation.

Contract laboratories are separated from your organisation and therefore optimal use of contract laboratories is achieved by careful consideration of the effect of this separation.

We look forward to hearing from you. Please contact us now to discuss your analytical requirements.