The
FDA has issued its work schedule for 2013. Listed below are the guidance
documents that it intends to produce or update during
2013:
- Quality Systems Approach to Pharmaceutical cGMP Regulation
- Uniformity of In-Process Mixtures
- Control of Highly Potent Compounds
- Contract Manufacturing Arrangements for Drugs: Quality Agreements
- Submission of Field Alert Reports and Biological Product Deviation Reports
For further details, see FDA
Posted by Tim Sandle
None of these seems any surprise to me as all are consistently in the news - usually for the wrong reasons!
ReplyDeleteJohn White
The Quality Compliance Partnership Ltd