01. EU GMP
GMP defines quality measures for both production and quality control and defines general measures to ensure that processes necessary for production and testing are clearly defined, validated, reviewed, and documented and that the personnel, premises and materials are suitable for the production of pharmaceuticals and biologicals, including vaccines.
GMP also has legal components, covering responsibilities for distribution, contract manufacturing and testing, and responses to product defects and complaints. Specific GMP requirements relevant to classes of products such as sterile pharmaceuticals or biological medicinal products are provided in a series of annexes to the general GMP requirements.
We can assist you in becoming GMP certified by creating and maintaining a quality system, provision of QP services, preparation of site for inspection and training of staff.