CRED Managing Variations Effectively

QP Declarations – GMP Compliance of API Site

• Several rejections due to incomplete/ incorrect QP declarations • QP declaration required from: – Each EEA manufacturing authorisation holder that uses the active substance as a starting material – The QP responsible for importation/batch certification where the batch release site differs to the above manufacturing site

Single declaration • Single Site • Multiple sites with

Multiple declarations • Multiple sites • Technical agreement not in place

or

technical agreement in place

• Site audit conducted within last 3 years www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webCo ntentId=WC500100727