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Regulatory Affairs White Papers

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1-15 of 50 results
NSF asks why Annex 1 is Important to you
| By NSF Health Sciences Pharma Biotech PBR
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 Health Sciences Pharma Biotech PBR
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 Health Sciences Pharma Biotech PBR
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 Health Sciences Pharma Biotech PBR
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 asks a Production Director for their views on moving forward with KPIs
| By NSF Health Sciences Pharma Biotech PBR
KPIs and the Production Director: Select Fewer, More Significant KPIs and Set Goals for Your Metrics
Regulatory Affairs > White Papers
NSF determines what KPIs mean for Employees
| By NSF Health Sciences Pharma Biotech PBR
KPIs and Employees: Involve Us Upfront and Let Us Help Define Relevant Measures
Regulatory Affairs > White Papers
NSF asks ex-MHRA Inspector about the Importance of KPIs and gets Interesting Results
| By NSF Health Sciences Pharma Biotech PBR
KPIs and the Regulator: I’m Looking for Quality Metrics, Management Review and Continual Improvement.
Regulatory Affairs > White Papers
Tech Talk: CHANGING GMP BEHAVIORS with NSF
| By NSF Health Sciences Pharma Biotech PBR
Most people are content sticking with what they know and their tried and tested habits. It’s easy. To get people to think and act differently (a painful process for most), you have to provide them with the motivation.
Regulatory Affairs > White Papers
NSF: KPIs and the Head of Corporate Quality: KPIs Are Essential for a Successful Product Release
| By NSF Health Sciences Pharma Biotech PBR
What are your views on KPIs? Essential or a necessary evil? “They are absolutely essential, providing they are good! I remember during a regulatory inspection I was asked every QP’s most feared question: How do you know everything is in control before you release product?
Regulatory Affairs > White Papers
NSF: Learn from a Fabulously Successful GMP Remediation Program
| By NSF Health Sciences Pharma Biotech PBR
This White Paper describes a remediation program that appeared at first to be impossibly daunting, expensive and unattainable. The company had received a range of critical and major GMP deficiencies from the UK regulatory body, MHRA, and was facing a referral to MHRA’s Inspection Action Group. Manufacturing had to be suspended pending a risk assessment of the non-compliances; evaluating the effect of the non-compliances in terms of risks of misbranding and adulteration of the products. Shifts were cancelled, the supply chain was suspended and an urgent remediation program begun.
Regulatory Affairs > White Papers
NSF: Remediation of Pharma Quality Systems – It’s All About the People
| By NSF Health Sciences Pharma Biotech PBR
Much of NSF Pharma Biotech Consulting’s work involves helping companies remediate flawed quality systems. This is usually done as a result of threatened or actual enforcement action by regulatory agencies. In these circumstances, companies are desperate and willing to do ‘whatever it takes’ without a full understanding of what that means. While expansive in concept, ‘whatever it takes,’ for many, means simply deploying internal and external resources to design and document a new quality management system. This is a significant commitment by management in resources, but unless the cause (how did this happen?) is also considered, the effort is doomed to fail.
Regulatory Affairs > White Papers
Brexit Implications for UK Pharmaceutical Administration with NSF
| By NSF Health Sciences Pharma Biotech PBR
With the historic vote by the UK to leave the European Union we have been asked by many of our clients and colleagues “What will the vote to leave the EU (Brexit) mean for pharmaceutical quality management and the role of the Qualified Person (QP)?” The only thing that is certain is that we are facing at least two, and probably more, years of unprecedented uncertainty.
Regulatory Affairs > White Papers
NSF: Techniques to tackle our current Complexity Crisis
| By NSF Health Sciences Pharma Biotech PBR
Over the last 30 years we have seen levels of complexity in the pharma industry increase dramatically. It’s getting close to a crisis point. Although some complexity is triggered by events we can’t influence (regulations, globalization and the like), most is created by choice.
Regulatory Affairs > White Papers
1-15 of 50 results