Articles from Validation Times (October 1, 2001)

Title	Author	Type	Words
Baxter's Round Lake, IL plant hit for sampling after particulates crop up.		Brief Article	730
Catheter maker J-Lloyd drops out after FDA audit.		Brief Article	742
Consultant, MCA official conflict on role of quality unit under Q7A.	Fields, Howard		1005
EU stresses in-process controls, but no post-approval audits in store.	Reid, Ken	Brief Article	520
Failure to revalidate cleaning procedure results in warning.		Brief Article	349
Failure to validate manufacturing, software, yields citation to Braun.		Brief Article	310
Failure to validate refrigeration unit yields letter to Bindley.		Brief Article	476
FDA version of Q7A 'should' not be binding as ICH version should.		Brief Article	310
FDA wants revalidated Paddock drug put on stability.		Brief Article	714
Firm cited for not validating its DI water system.		Brief Article	369
Lack of QC, QA cited at hydrotherapy maker.		Brief Article	208
New FDA mission: fighting counterfeit drugs, ensuring armentarium for bioterrorism.		Brief Article	756
Not documenting validation of design requirements, software draws warning.		Brief Article	450
Not following written SOPs cited at Syncor International.		Brief Article	357
Not validating stability testing methods draws warning letter for Sonar.		Brief Article	232
Not verifying and validating corrective and preventive action land Lang a warning.		Brief Article	271
Sera-Tec gets warning for violating QA procedures.		Brief Article	304
Team Biologics audit nets Genentech a recall.		Brief Article	767
Validation still needed despite new technology; monoclonal guide can help.	Reid, Ken	Brief Article	746
Warnings given to medical gas firms for GMP issues, including calibration.		Brief Article	701