Clinical Research Solutions
Compliance Auditing: A Peek into Common Critical Findings
Compliance auditing is a crucial process in the pharmaceutical industry, that helps ensure the safety, effectiveness, and high quality of pharmaceutical products and medical devices. Compliance...
Clinical Research Solutions
The Importance of Responding to FDA 483 Observations
This article has been updated since its original publication date. The FDA has an established policy that allows companies 15 days to respond in writing to the FDA after issuance of a 483...
Clinical Research Solutions
Top Tips for a Successful Virtual Audit
The COVID-19 pandemic forced countless companies to change the way they do business in order to continue operating while protecting employees and upholding their social responsibility to the...
Clinical Research Solutions
Embracing Risk Management Principles: As Easy as One, Two, Three
In the pharmaceutical industry today, there are strict guidelines to adhere to throughout the product lifecycle. Some of them, like risk management, seem more complex and harder to adhere to than...
Clinical Research Solutions
Event Recap: MHRA Good Practice Symposia Week
This year, four members of our team attended the MHRA Good Practice symposium week. Part of this week were the GPvP Symposium and the joint MHRA and FDA GCP Symposium. Part of ProPharma Group’s...
Clinical Research Solutions
FDA: CGMP Consultant Recommendation
Reflecting on my interactions with FDA I have come to understand that inspectors do not routinely offer recommendations to firms, when an inspector does provide an opinion it is often prefaced with a...
Clinical Research Solutions
Get the Most Out of Your GMP Effectiveness Checks
Get the Most Out of Your GMP Effectiveness Checks: We work in a highly regulated industry. Whether you are associated with the manufacturing of a drug, a biologic, or a device, you understand the...
Clinical Research Solutions
Deviations: Beyond the Basics
Deviations: Beyond the Basics: There are plenty of guidelines and instructions on implementing a deviation system in a pharmaceutical/medical device company. However, there is a big difference...
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FDA's Top 483 Observations for 2018: A Reflection of Industry’s Compliance
At the beginning of each federal fiscal year, the US FDA posts the previous year's Form 483 observation metrics issued by each product center. Inspections ending between 10/1/2017 and 9/30/2018, for...
Clinical Research Solutions
Assumed Brexit & Batch Control Testing Site In the UK
The currently scheduled transition date in the Brexit process, 30 March 2019, is coming very close. In light of this, the European Commission (EC) published on 25 February 2019 a notice on the...