Regulatory Affairs

Regulatory Affairs White Papers

View white papers from other Pharmaceutical sectors:
1-15 of 53 results
Data Integrity A Closer Look
| By NSF International
Data integrity remains a perennial hot topic impacting the pharma biotech industry and the trend has been picking up steam; the number of data integrity-related warning letters has increased consistently since 2010. A number of new guidance documents came out in 2016 by FDA, MHRA, EMA PIC/S and the WHO and yet companies continue to grapple with data integrity issues.
Regulatory Affairs > White Papers
Hierarchy For Capa Effectiveness
| By NSF International
Have you ever reviewed an investigation report and wondered whether the proposed corrective and preventive action (CAPA) would be effective? Sometimes, we shrug our shoulders and say, “At least they put something in place”. We all know that the FDA expects us to include an effectiveness check, but do we have enough guidance to make these checks meaningful? NSF suggests that you consider these three questions: 1. What will you measure? 2. When will you measure it? 3. What is your acceptance standard?
Regulatory Affairs > White Papers
Is Fear of Risk Your Biggest Risk?
| By NSF International
In this white paper, NSF International's Martin Lush gives his insights into the pharmaceutical industry's relationship with risk. It includes five steps to help you become risk smart.
Regulatory Affairs > White Papers
Risk Assessment: A Closer Look
| By NSF International
NSF International’s Andy Barnett takes a deeper look into ICH Q9, Quality Risk Management, with particular focus on the failure mode and effects analysis tool for risk management.
Regulatory Affairs > White Papers
Aging Facilities
| By NSF International
Aging facilities is a trendy catchphrase that has taken hold in the biopharmaceutical industry. This white paper by NSF International’s Nicholas Markel provides a few questions to determine if you have an aging facility as well as how to address any issues you may have.
Regulatory Affairs > White Papers
NSF: Global Selection Considerations for CMO When Conducting Due Diligence
| By NSF International
Deciding to use a CMO requires a thorough due diligence exercise conducted both as desktop and on-site reviews. This NSF white paper by Maxine Fritz provides the fundamental factors to consider when engaging and deciding on a CMO.
Regulatory Affairs > White Papers
NSF: Time To Move Beyond Mediocre CAPAs and Make Them More Effective
| By NSF International
Have you ever wondered why some of your CAPAs fail to achieve the desired improvement? Wouldn’t it be nice if there were a way to evaluate the CAPA before you implement it? NSF proposes the use of our CAPA hierarchy, which will help investigators select a CAPA that is most likely to deliver the desired outcome. Read the white paper for more information on the hierarchy and find out how else to use it.
Regulatory Affairs > White Papers
Do you have a robust and compliant CAPA System?
| By NSF International
Pharma biotech companies around the globe are struggling to juggle numerous priorities and challenges. One of their biggest struggles is to effectively manage CAPAs.
Regulatory Affairs > White Papers
How to write to Regulatory Agencies when things go wrong
| By NSF International
Your essential guidance on what to do next after you receive a less than positive regulator's audit report.
Regulatory Affairs > White Papers
NSF asks why Annex 1 is Important to you
| By NSF International
This white paper details the key reasons for the revision to EudraLex Volume 4, Annex 1: Manufacture of Sterile Medicinal Products. It outlines what you should be asking yourself regardless of the dosage form you are responsible for. It also includes a simple tool to assess the impact on your organization when there is a regulatory change.
Regulatory Affairs > White Papers
Heightened FDA Enforcement for Sterility Issuesin Pharma Biotech with NSF
| By NSF International
NSF analysed all of the warning letters issued to pharma and biologic manufacturers for sterility issues since 2015. This white paper provides detailed insight into our analysis. It includes relative charts and a table with a summary of the regulations cited by the FDA as well as recommendations for closing your compliance gaps.
Regulatory Affairs > White Papers
NSF: Essential Rules When Investigating GMP Deviations During Sterile Processing
| By NSF International
This white paper by John Johnson outlines the key attributes to consider during sterile products manufacturing. It also details five key non-negotiables for investigating pharmaceutical GMP deviations or deficiencies in sterile processing.
Regulatory Affairs > White Papers
NSF Explains the Points to Consider when Auditing a Terminally Sterilised Drug Product
| By NSF International
When conducting an audit of the terminally sterilized pharmaceutical product process, the essential checklist outlined in this white paper by Maxine Fritz will help.
Regulatory Affairs > White Papers
NSF - Site Director: KPIs Should Look Forward as well as Measure Results
| By NSF International
A Site Director expresses his views on how to use KPIs most productively.
Regulatory Affairs > White Papers
NSF asks a Production Director for their views on moving forward with KPIs
| By NSF International
KPIs and the Production Director: Select Fewer, More Significant KPIs and Set Goals for Your Metrics
Regulatory Affairs > White Papers
1-15 of 53 results