ËÄÉ«AV

The analytical development laboratory focuses on providing a comprehensive understanding of the chemical and physical properties of particles. ËÄÉ«AV analytical laboratories can support all different requirements of a project at all stages of development and production.

At ËÄÉ«AV, product specific analytical methods are established for process control, product release and intermediate / raw materials release and validated according with the process stage of development. Moreover, identification of impurities, qualification of reference standards and stability studies conforming to ICH guidelines are offered as routine services.

How we make a difference:

1. Phased approach to analytical method validation

2. Phased approach to analytical method transfer

In Process Control (IPC)

The IPC teams work 24 hours a day, 7 days a week assuring the in time testing of all in process control samples and the approval of intermediate products. It also assures the analytical cleaning verification of the equipment before and after batch production. All raw materials used in manufacturing are previously tested as per the specifications defined and approved for use. Release of final product is conducted by experienced analysts and checked by analytical chemists and QA.ÌýAll analytical data is available in LIMS system and is shared with customers in real time via IT platform.
The analytical teams are composed of well trained and experienced personnel, covering a wide range of analytical techniques.

Development of Analytical Methods

Our Analytical Chemists have extensive experience in developing reliable and reproducible analytical methods that allow testing the physical and chemical characteristics of the drug substance/product in a structured, focused, and step-wise approach. QbD tools, for example risk assessment and design of experiments, enable enhanced quality to be integrated into the analytical method and leading to an earlier understanding and identification of variables affecting method performance.

Method Validation and Transfer

Validation of an analytical method is the process by which it is established that the performance characteristics of the procedure meet the requirements for the intended analytical applications. It is essentialÌýfor compliance with current Good Manufacturing Practice (cGMP) regulations and international regulatory guidelines. The validation requirements depend on the particular stage of the product lifecycle and type product under evaluation, recognizing the differences among, and the goals of each stage.

At ËÄÉ«AV we offer a multidisciplinary group of experts dedicated to method validation, and verification of compendia procedures for testing of critical raw materials, intermediates, drug substance / drug product, excipients and cleaning procedures. ËÄÉ«AV has performed numerous method validations during its more that 60 years in the pharmaceutical world, having a significant know-how on this field.

Types of Methods validated at ËÄÉ«AV:

1. Limit tests
2. Ppm methods
3. Pass/fail methods
4. Qualitative and quantitative physical tests
5. Inhalation tests
6. Dissolution
7. ACI/NGI

Stability Studies

ËÄÉ«AV has dedicated resources for stability analysis under GMP and informal environments for drug substances (powder or liquids) and drug products (tablets, suspensions, others). Results are released per time point on a cumulative stability table (interim report with QA approval). All stability studies are managed by a LIMS specific stability module.

The team also has capabilities for samples storage at all ICH conditionsÌýin at an outsourced facility, and internally for photo stability studies under controlled conditions.