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View white papers from other Pharmaceutical sectors:
16-30 of 79 results
Vetter Development Service Chicago
| By Vetter Pharma International
Our premium manufacturing and clinical supply site near Chicago, Illinois, has the people, processes, and technology to serve pharma and biotech companies of every size with customizable solutions for drug compounds in any stage from Preclinical Testing to Phase II and beyond.
Contract Research & Services > Contract Services > White Papers
Vetter-Ject® Syringe Closure System
| By Vetter Pharma International
Today’s complex, sensitive biologic compounds demand new, innovative delivery systems. The Vetter-Ject® closure system allows you to offer the convenience of a syringe in a design that addresses the unique requirements of highly sensitive compounds.
Contract Research & Services > Contract Services > 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.
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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.
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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.
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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.
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Softigel introduces new energy gummies at vitafoods
| By Softigel pbr
Who hasn´t needed a wake-me-up in the morning or hasn´t dragged a tired body to the end of the day? Regardless how we individually spend our day, the intensity of our routine, the sports practice or the stressful of our labor; the common consequence is the high demand and lack of energy.
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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
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NSF determines what KPIs mean for Employees
| By NSF International
KPIs and Employees: Involve Us Upfront and Let Us Help Define Relevant Measures
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NSF asks ex-MHRA Inspector about the Importance of KPIs and gets Interesting Results
| By NSF International
KPIs and the Regulator: I’m Looking for Quality Metrics, Management Review and Continual Improvement.
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Tech Talk: Changing GMP Behaviours with NSF
| By NSF International
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.
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NSF: KPIs and the Head of Corporate Quality: KPIs Are Essential for a Successful Product Release
| By NSF International
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?
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NSF: Learn from a Fabulously Successful GMP Remediation Program
| By NSF International
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.
Contract Research & Services > Contract Services > White Papers
16-30 of 79 results