Quality Systems

Articles

Altaire is voluntarily recalling ophthalmic products because of concerns regarding quality assurance controls in the manufacturing facility.

Altaire Pharmaceuticals Recalls Multiple Ophthalmic Products

FDA sent a warning letter to Ecometics, Inc. after the agency found CGMP violations at the company’s Norwalk facility.

Connecticut Manufacturer Gets FDA Warning Letter

The draft guidance describes how content should be organized in electronic submissions for all submission types under section 745A(a) of the FD&C Act.

FDA Releases Guidance on Electronic Submissions

Slovakia becomes the final European Union country to be recognized by FDA, and the mutual recognition agreement for inspections of manufacturing sites between the US and the EU is now fully implemented. 

US and Europe Reach Mutual Recognition Agreement Goal on Inspections

The FDA guidance defines changes to approved risk evaluation and mitigation strategies and clarifies submission guidelines. 

FDA Finalizes REMS Guidance

The draft guidance provides industry with a guide for using the database to assist in the development of drug products.

FDA Releases Draft Guidance on Using the Inactive Ingredient Database

FDA released draft guidance on using the USP pending monograph process in the drug application process. 

Guidance on the Harmonization of Compendial Standards Published

FDA sent warning letters detailing violations of current good manufacturing practices to three companies that repack APIs. 

Ingredients Repackers Get Warning From FDA

Siegfried Schmitt, PhD, is Vice President Technical at Parexel International, Siegfried.Schmitt@parexel.com.

Cultural and language discrepancies during an audit can be resolved using what many call a “playbook,” says Siegfried Schmitt, PhD, vice-president, technical, Parexel Consulting.


Playbooks Are Not Just Child’s Play

Hallie Forcinio is packing editor for Pharmaceutical Technology and Pharmaceutical Technology Europe, editorhal@sbcglobal.net.

Today’s inspection systems catch tinier flaws, manage data, and increasingly rely on artificial intelligence to further boost performance.

Quality Assurance/Quality Control