By PolyCrystalLine S.R.L.
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PolyCrystalLine gains cGMP certification for qualitative and quantitative analysis
Bologna, Italy:- European health authorities have awarded Good Manufacturing Practice (GMP) status to crystalline form specialist CRO PolyCrystalLine Srl. Following a successful audit.
PolyCrystalLine‘s cGMP certification covers chemical and physics analyses for qualitative and quantitative determination of active ingredients, intermediates and finished products.
Specifically, the certification approves PolyCrystalLine’s use of X-ray powder diffraction, Fourier transform infrared (FTIR) spectroscopy and FT-Raman spectroscopy.
While the certificate takes effect from early 2015, PolyCrystalLine has already drafted and signed the Technical Agreement that specifies internal roles and responsibilities related to production and control of the drugs. This ensures compliance with current GMP practices and standards.
PolyCrystalLine CEO, Dr. Stefano Luca Giaffreda, welcomed the award of cGMP status as a significant step forward for the company.
“We have been working very hard for many months to ensure successful audit and to show that the precision and rigor of out diffraction and spectroscopy match the best in Europe,” said Dr. Giaffreda.
“I would like to pay tribute and to thank everyone involved in that effort,” he added.
“Now the awarding of cGMP status recognizes that PolyCrystalLine can operate to the highest standards,” said Dr. Giaffreda.
PolyCrystalLine Srl has rapidly established prominence in research and characterization of crystal forms and solid-state compounds, particularly in the pharmaceutical field.
The company has its roots in academia, building on research and collaborative networks to form a business. Academic knowledge is combined with business skills, employing a close relationship with scientific methodology to construct original, forward-thinking approaches to solve technical, patenting and commercial problems.
PolyCrystalLine’s extensive experience in the characterization of solid-state compounds and the study of polymorphism has been leveraged into development of explicit and adaptable research protocols that can be adjusted to meet the requirements of the pharmaceutical industry. It investigates the thermal behaviour of pharmaceutical compounds through a wide range of methods including X-ray powder diffraction, calorimetric, thermogravimetric and evolved gas analysis.
The company is able to meet a diverse range of research needs and budget requirements, from comprehensive analysis of APIs and compounds/solvates to rapid low cost screening and studies that involve patent issues.
It can provide crystallization processes utilising modular approaches ranging from milligrams to half kilogram scale, along with expert knowledge in regards to the optimization of different parameters during the crystallization processes to achieve desired crystal forms, yields, particle size, etc.
PolyCrystalLine clients include AET, Bracco, Chemi, DeveloPharma, Dipharma, Novartis, Polpharma, Rivopharm and Zach System.