Pharma

Medical Devices 101 – Overview of Key Regulatory Requirements

FDA`s Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States. In addition, CDRH regulates radiation emitting electronic products (medical and non-medical) such as lasers, x-ray systems, ultrasound equipment, microwave ovens and color televisions. Medical Read more…

By Nia, ago
Pharma

How to Use and Validate Excel Spreadsheets to Ensure Compliance under FDA’s 21 CFR Part 11

In FDA-regulated industries, it is imperative that manufacturers for drugs, biologics, biosimilars and medical devices including IVDs demonstrate FDA-compliant implementation of 21 CFR Part 11 (Part 11) requirements.  The FDA frequently states in their warning letters, “failure to maintain complete data; failure to prevent unauthorized access or changes to data Read more…

By Nia, ago
Pharma

FDA Refuse-To-Accept (RTA) Guidance for 510(k) Submissions

Are you contain necessary component or you complete all step of 510(k) submission to allow consume Center resources? The Office of Device Evaluation (ODE) receives approximately 6500 Premarket Notification (5100) submissions every year. Many of these submissions are incomplete or grossly inadequate, as they fail to contain the components necessary Read more…

By Nia, ago
Pharma

Drug Safety & Pharmacovigilance

Everyone in the pharmaceutical should have a basic understanding of Drug Safety and Pharmacovigilance for FDA compliance. Drug Safety and Pharmacovigilance is there throughout every step of the drug development, but there is so few information with the basic fundamentals available to help new people within drug safety or anyone Read more…

By Nia, ago
Pharma

Data Integrity – FDA’s Latest Thinking

The recent influx of concerns over data manipulation and other data integrity questions in India, China and elsewhere has pushed the US Food and Drug Administration (FDA) to put out new draft guidance to help the pharmaceutical industry ensure data is consistent and accurate. The guidance includes 18 questions and Read more…

By Nia, ago
Pharma

Sterility Failure Investigations

The intent of this article is to provide practical advice based upon gaps that the author has observed during investigations into numerous sterility test failures. The approach described will also apply to other types of viable microbial contamination events, such as process simulation test (media fill) failures. The author hopes Read more…

By Nia, ago
Pharma

Steam Sterilization Microbiology and Autoclave Performance Qualification

Autoclave: Performance Qualification (PQ) An autoclave undergoes qualification testing in order to validate and verify that it’s performing consistently and properly. In previous posts, we outlined the first two qualification tests known as Installation Qualification (IQ) and Operation Qualification (OQ). In this post we will review Performance Qualification (PQ) as a final critical step Read more…

By Nia, ago
Pharma

6 QUICK TIPS ABOUT EXCEL SHEET VALIDATION

Are you using Excel spreadsheets? And are these used for GxP activities? Are these Excel sheets used again and again, as a template? Ever thought about validating such templates? Is the person who built your spreadsheet a genius with Excel, but doesn’t know how to validate? Want to use spreadsheet Read more…

By Nia, ago
Pharma

Audit Trail Generation and Review

The audit trail is an integral requirement of an electronic record, ensuring the validity and integrity of the record and the link between any electronic signature and the record associated with it. Its regulatory requirements are fairly straightforward, but the benefits it offers are often misunderstood. Audit trail reports can Read more…

By Nia, ago