Chemika’s approach to quality is to deliver compliant and high quality outcomes through intelligent implementation of regulation and data integrity principles.
Quality systems
Chemika seeks to solve analytical problems through sound science and technology. A scientific approach to compliance leads to the most workable and economical solution, and the solution which is most favoured by regulators.
Chemika is regulated by both the TGA & APVMA in Australia and have extended registrations to include the US FDA. 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.
Data Integrity
The foundations of data integrity are laid with corporate values and operating priorities which mean that staff will never feel pressured to report anything other than genuine and complete results of tests which have been performed. Staff are encouraged and required to be open and understand that tests don’t always go as planned, and that there is no situation where management cannot be called on for advice and help.
Chemika’s implementation of data integrity principles build on the foundation and are a clear way of demonstrating the integrity of results. Data must be attributable, legible, contemporaneous, original, and accurate as well as being complete, consistent enduring and accessible. Server based analytical systems allow this to be evaluated in real time, with examination of audit trails being completed for every analytical result released to clients, where instrumental methods were employed.
Staff 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.
Our commitment to staff development is demonstrated by the most senior positions being filled by scientists who commenced their career at Chemika. Supplemented by further education in the University or TAFE systems, we have reaped the benefit of this investment in our people.
Openness
We understand that the organisation which releases therapeutic goods for sale ultimately takes responsibility for the quality of the product. We support our clients by providing high quality and reliable analytical data, and through providing access to raw data when required. Analytical data can be a mixture of client owned IP, information in the public domain and IP owned by Chemika.
Our first aim is for our customers to have total confidence in the analytical data and this takes precedence over any need to protect our IP, where the information is to be used for quality assurance and release for sale.
Control of Retest and OOS 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.
The treatment of OOS results have evolved and the current requirement is that all results are considered as valid unless the cause of error is identified or if a sound scientific procedure is used to show the result is impossible. The current OOS procedure at Chemika has been built on the requirements of PIC/S, the MHRA and the FDA.
We understand that our clients will have their own procedures for treating OOS results and we will work within your requirements to achieve resolution.
System Suitability Checks Performed for all Samples
Chemika doesn’t consider GMP requirements to be “optional extras”. System suitability checks are carried out on all samples tested.
Instrumental methods almost always include measurements which demonstrate the instrument is functioning correctly, and the required method performance is achieved. This typically includes various “system suitability” checks such as instrument precision, sensitivity, peak asymmetry or resolution.
Chemika will always implement system suitability checks required for every sample being tested. All chromatographic assays will include 6 injections to determine the instrument precision, and analysis of a duplicate standard to confirm calibration (unless the test method specifies an alternative system test). Customers are not required to specifically request these checks to be carried out.