The pharmaceutical industry is highly regulated, and products of high and consistent quality are essential. When manufactured ingredients are used in drug or vaccines formulations, risk of quality failures must be minimised, and ultimately patient safety ensured. Especially, when the vast majority of more than 1 billion doses of vaccines manufactured worldwide each year are given to perfectly healthy people (World Health Organisation). It is this fact that drives the requirements for these ingredients to be among the most rigorously designed, monitored, and compliant products manufactured today.
The ability to manufacture pharmaceutical ingredients safely and consistently is built on four competencies:
- the manufacturing process that defines how the product is made;
- the compliance of the organisation to successfully complete that process;
- the testing of the product and supporting operations; and
- the regulatory authorisation to release and distribute the product.
All these competences are present at every Croda’s manufacturing sites and Quality and Pharma Regulatory Affairs are key functions for our Health Care Business. Product quality is controlled on every site where our skilled quality personnel maintain appropriate quality system processes and quality control measures before a product is released for distribution.