Regulatory Affairs

Regulatory Affairs White Papers

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1-15 of 55 results
THE FUTURE OF THE PHARMACEUTICAL INDUSTRY
| By NSF International
YOUR CHANCE TO CONTRIBUTE by Martin Lush Ever participated in one of those benchmarking exercises? You know what I mean. When a (usually) fresh-faced consultant asks lots of questions and fills in a spreadsheet comparing what you do with your competitors. Well, beware.
Regulatory Affairs > White Papers
REVIEW OF EU ATMP GMP GUIDANCE
| By NSF International
On November 22, 2017, the EU Commission adopted the Guidelines on Good Manufacturing Practice specific to advanced therapy medicinal products (ATMPs), as Part IV of EudraLex Volume 4. These guidelines come into force on May 22, 2018. When these GMP guidelines for ATMPs were first drafted, most of the manufacturers of ATMPs were critical of the guidelines being a separate guidance document rather than being an annex to the existing guidelines in EudraLex Volume 4. There were also criticisms from smaller academic and hospital units that the new guidelines place too much burden on these units in their rigid application of industrial type GMPs, which they argued was not practicable to these highly innovative products. Concern was also expressed that as the initial draft stood, the innovative research that was going on with ATMPs would be hindered in the EU.
Regulatory Affairs > White Papers
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
1-15 of 55 results