
Are material releases being delayed while your testing laboratory completes investigations?
Laboratory reporting times play a crucial role in the timely approval of incoming goods and the release of finished products. Constantly adjusting manufacturing schedules due to delays in raw material release can be both frustrating and disruptive.
Delays don’t just depend on analysis reporting times but also on how quickly unexpected results or OOS investigations are resolved.
At Chemika, initial OOS investigations are completed within 48 hours. This efficiency reduces headaches, clears quarantine congestion, and keeps production moving smoothly.
We achieve this because our organisation is quality-focused, and our systems are optimised to achieve GMP compliance efficiently.
Since our establishment in 1998, we have provided services on a “GMP-inclusive” basis. This means we fully embrace our customers’ GMP requirements, including them as an essential part of every test.
Our analysis pricing includes:
- System checks required by GMP, such as measurements of instrument precision or chromatographic resolution.
- Timely OOS investigations with well-defined triggers.
- Resources dedicated to achieving these objectives effectively.
Rapid and Comprehensive OOS Investigations
Our investigations follow the MHRA scheme, progressing through Phase 1a to Phase 3 where necessary, and consist of two parts:
- Immediate Initial Investigation
As soon as the OOS is recognised—ideally right after analysis—rapid checks are performed. These include basic sanity checks plus checks on items which may not be available indefinitely, such as solutions volumes, appearance and volumetric apparatus (MHRA Phases 1a and 1b). - Detailed Follow-Up
Following the initial checks, more thorough investigations are conducted. These may include investigative measurements or, when appropriate and agreed upon, sample retesting (MHRA Phases 2 and 3).
By closing OOS investigations quickly, we help you:
- Accelerate material release for production.
- Make timely decisions on whether goods can be released for sale.
At Chemika, we combine speed, efficiency and quality to ensure you stay on track and achieve your operational goals.