METHOD VALIDATION
We use comprehensive and fit-for-purpose procedures for the transfer, validation or even development from scratch of pre-qualified, pharmacopeia compendial and in-house methods in line with our client’s requirements and according to ICH, EMA, and FDA guidelines. Our team is extremely proficient through exposure to a wealth of different APIs, excipients, preservatives, intermediates, and finished pharmaceutical products from pharma innovators with novel compounds or manufacturers of commercialized drug products. Our development and validation services often act as the entry gate for projects involving the following disciplines:
Analytical Method Development and Validation
• Identification
• Assay testing
• Related Substances
• Residual Solvents
• Elemental impurities
• Orally and Nasally Inhaled Drug Products
• Cleaning
• UV/visible spectroscopy
• HPLC: Variable wavelength (VWD), diode array (DAD)
• GC: Flame ionization detector (FID), and headspace analysis
• Volumetric Titrator
• Karl Fisher volumetric and colorimetric
• Tween impinger test for inhalers
• Universal testing ,…..
Neutron offers method development and validation for pharmaceuticals, chemical and related industries Analytical method development and validation are essential in drug development and manufacture. Once a method has been developed, it is a key requirement to prove that the method is suitable for its intended use. A validation is performed to verify the method’s suitability and, if successful, the method is deemed valid to use for its purpose.
Method development
Method development and validation can be a complex story when development of a method was not performed well, to overcome this Neutron has systematic procedures to guide our Customers through this process. Our team is experienced in developing methods for drug products, APIs and excipients, as well as healthcare products and cosmetics. With a well developed method, validation is just a formality.Our laboratories are equipped to perform method development and validation studies. Additionally, Neutron performs forced degradation studies including acid, base, peroxide, light and temperature. A forced degradation study is an essential tool in developing stability indicating methods.
Method validation After a successful method development, the suitability of the method should be verified with a method validation. Synergy Health performs method validation studies in accordance with ICH guidelines. Before we begin a validation, we edit a method validation protocol, which is shared with our Customer for approval. Once the validation is approved, we begin the study and the following parameters are tested regularly specificity, limits of detection and quantification, linearity, accuracy, precision and robustness. Upon completion, all results are presented to the Customer in a validation report. Additionally, Neutron offers cleaning validations. Cleaning validations are of high importance in the manufacturing and packaging of pharmaceutical products. Analytical Method Transfer. To qualify a laboratory for a new method a method transfer needs to be performed. There are several ways to transfer an analytical method from one to another laboratory. Together with you as our Customer we will find the right model for transfer of your method to Neutron within regulatory boundaries.
EQUIPMENT QUALIFICATION
Neutron IQ/OQ documentation was founded on the following documentation tree
EQUIPMENT CALIBRATION
Regular calibration of instruments is commonplace for process manufacturers. But in the Pharmaceutical industry particularly
TRAINING
These types of training methods do not make a full list, but they are the general methods that might be divided into sub-categories
PROCESS VALIDATION
GMP validation is an element of quality assurance program for a pharmaceutical/biotech product or process.