New FDA Guidance Documents in Calendar Year 2011
On January 26, 2011 the FDA issued the Guidance Agenda: New & Revised Draft Guidances CDER plans on publishing during the calendar year 2011.
The document is structured in different categories. With regard to Current Good Manufacturing Practices (CGMPs)/Compliance a number of documents are listed. Some of them will be of high interest for industry, like:
- Contract Manufacturing
- Control of Highly Potent Compounds
- Importation of Active Pharmaceutical Ingredients (API) for Use in Human Drugs
- Non-Penicillin Beta-Lactam Contamination
- Pharmaceutical Component Quality Control
- Compliance Policy Guide Section 490.200 for FDA Staff: Parametric Release - Drug Products Terminally Sterilized by Moist Heat
In the category "Chemistry" the FDA plans on developing among others the following Guidelines:
- CMC Postapproval Changes Reportable in an Annual Report and
- Comparability Protocols for Approved Drugs: CMC Information
Source: Federal Register and CDER Webpage
Related GMP News
25.06.2025Is Knowledge Management a Part of the Pharmaceutical Quality System?
11.06.2025Swissmedic differentiates GMP Scope for Manufacturing and Preparation for Administration
28.05.2025A View on the EU Critical Medicines Act to secure Pharma Supply Chains
20.05.2025Summary Data on Registration and Listing of Cosmetic Facilities and Products
07.05.2025FDA is extending its Quality Management Maturity Programme
30.04.2025FDA Warning Letter on missing Audit Trails and Raw Data Review