The Best Practice Model is a concept whereby the members of the SSPC will work together to define the best known methodologies in current thinking for development and manufacture of Pharmaceutical API crystals. Throughout Industry and academia there is no such system in place. All Pharmaceutical companies use their own 'imperfect processes' in the development of Pharmaceutical Manufacturing processes. The concept of Best Practice proposes to pool the resources of all industrial and academic members in the cluster to develop a Best Practice manufacturing process from Solvent Selection to final API powder handling methodologies. Taking into consideration pre-formulation and analytical concerns the aim is to have a pool of knowledge available centrally to cluster members for design and scale-up of their individual NCE process or to optimise their current API manufacturing process.

The steering Committee for the best Practice model is outlined below with working groups in the following areas:

1. Solvent Selection

2. Equpment Selection

3. Crystallisation Conditions

4. Isolation including washing

5. Drying including Spray-drying

6. API Powder handling

7. Pre-Formulation

8. Analytical Methods

Steering Team

Name	Organisation	Role
Jon O'Halloran	UL	Project Leader
Liam Tully	Pfizer	Member
Tom O'Ceallaigh	Merck Sharp & Dohme	Member
Brian Glennon	UCD	Member
Humphrey Moynihan	UCC	Member
Anne Marie Healy	TCD	Member