Id Counterfeit Pharmaceuticals with Portable Raman
Rigaku
Following public consultation the European Commission (EC) has stopped the preparation of a directive on good manufacturing practices (GMP) for certain excipients.
Concerns were raised by stakeholders and experts from member states that there is a lack of flexibility in the proposal, which lists certain excipients that GMP should be applied to.
The results of the consultation suggest that a “balanced approach” is needed, with GMP for excipients being worked into legal requirements for pharma manufacturing and quality control.
GMP requirements for certain excipients is still viewed as “justified both from a public health and a business perspective” but should be linked to a formal decision making process by the manufacturer of the medical product.
