Quality Systems

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

Articles

Virtual audits, virtual training, and more robust quality agreements may become positive impacts on the industry, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates.


Impact of Pandemic on Permanent Procedures

FDA sent a warning letter to LEC Custom Products for a variety of CGMP violations including use of inappropriate equipment and processes.

FDA Finds CGMP Violations at Canadian Facility 

The amount of detail included in SOPs may help a company stay compliant, says Susan J. Schniepp, Distinguished Fellow at Regulatory Compliance Associates, LLC.

Writing Effective SOPs

The agency sent a warning letter to Kalchem International for CGMP violations found at the company’s Lindsay, OK, facility.

Oklahoma Facility Given FDA Warning

The agency sent a warning letter to Acella Pharmaceuticals detailing CGMP violations and failures to oversee contract manufacturers.

Georgia Facility Receives FDA Warning Letter

The agency sent a warning letter after an inspection of the company’s Sangareddy District, India found inadequate cleaning procedures.

FDA Sends Mylan Warning Letter

The UK's MHRA will resume on-site risk based GxP inspections from September 2020.

MHRA to Resume On-Site Inspections in September 2020

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

A new FDA guidance provides answers to questions about when the agency will seek to visit a site during the COVID-19 pandemic and how it will respond when a needed inspection cannot be conducted safely. 

FDA May Delay Approval of Drugs Where Necessary Inspection Is Not Feasible

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

FDA relies on risk assessments, border inspections, and compliance histories in place of routine audits during the COVID-19 pandemic.

FDA Takes Calculated Approach to Auditing during COVID-19

FDA sent a warning letter to ACRX Specialty Pharmacy Inc. detailing violations of the Federal Food, Drug, and Cosmetic Act and deficiencies in sterile manufacturing practices.

Audits and Inspections