Product news > QA/QC & validation
Technical / white paper
Sample Prep Proposed USP<233> Elemental Impurities - SGS
30-Jan-2012 -
Proper sample preparation is crucial when analyzing for trace metals using inductively coupled plasma (ICP). This paper illustrates how solubility of the test article may not be the primary factor when choosing a sample preparation method.
Technical / white paper
Glycosylation of Proteins: Structure & Analysis - SGS
06-Dec-2011 -
Glycosylation is one of the most widely observed, and structurally diverse, forms of post-translational modification of proteins and glycans have been shown to have a range of specific biological roles.
Mass spectrometry-based techniques provide an extremely powerful tool for glycan...
Application note
Monoclonal Antibodies Characterization - SGS
14-Nov-2011 -
A number of new monoclonal antibody products and monoclonal antibody biosimilars are in development, all require extensive characterization to obtain the necessary approvals for clinical trials and eventually marketing approval. Download this paper to read more.
Technical / white paper
Ensuring Quality & Regulatory Compliance when Working with a CDMO - DPT
24-Oct-2011 -
Learn the three elements needed to ensure regulatory compliance & product safety, purity and potency.
Careful choice of your service provider
Effective partnership management
Mutual commitment to constant improvement
Data sheet
Partnering with Your CDMO for CMC Preparation - DPT
04-Oct-2011 -
Collaborative partnering between Contract Development and Manufacturing Organizations (CDMO) and the drug product submission applicants (Applicant) is becoming increasingly important with the emphasis on product design by regulatory agencies. The CDMO can provide the appropriate resources to build the scientific...
Technical / white paper
Batch Retesting for Product Release in the EU - SGS
12-Sep-2011 -
The sale of medicines in the EU is regulated to ensure their efficacy and safety. For medicines manufactured outside of the EU/EEA, each product batch must obtain certification in the importing country.Download this paper for the regulatory details
On-Demand Supplier Webinar
Are you getting the right bioavailability and bioequivalence data for inhalation products you’re developing? - DPT
16-May-2011 -
Consider the risk to your development program of not accounting for patient variation in device handling. In this webinar DPT Labs and Proveris Scientific team up to demonstrate how the Ergo system can help you develop the right actuation parameters...
Video
Reducing Routine Testing Costs with GWP® Verification - Mettler Toledo
04-Apr-2011 -
The most important measure for accurate weighing: Knowing the minimum weight of your instruments and always weigh above it!
This new consultative service from METTLER TOLEDO certifies the minimum weight of your weighing instruments on site. Furthermore, the documentation contains...
Case study
SAFC's Approach to Productivity and Regulatory Compliance Improvements for Vaccine - SAFC Pharma
01-Dec-2010 -
This case study highlights the collaboration between SAFC and Oncolytics Biotech Inc, a Calgary, Canada-based biotechnology company, to address concerns of their novel cancer treatment, REOLYSIN®, and to assist in the development of a scalable and controlled production process.
Technical / white paper
White Paper on Forced Degradation Studies - SGS
08-Nov-2010 -
The stability of a drug product or a drug substance is a critical parameter which may affect purity, potency and safety. This white paper outlines how to approach a forced degradation versus a real-time stability study.
On-Demand Supplier Webinar
Reducing Out-of-Specification results in QA/QC - Mettler Toledo
11-Oct-2010 -
Weighing out powders to prepare samples and standards for analytical methods such as HPLC can be a time-consuming task with high error risk. With the advent of faster analytical methods, such as UHPLC, and rapid advances in software developments providing...
Case study
Greater Process Availability in Lysine Production - Mettler Toledo
23-Aug-2010 -
Successful manufacture of lysine relies on strict control of dissolved oxygen (DO). For one of the world’s largest lysine producers, switching to optical DO measurement has resulted in increased process availability and less maintenance.
Technical / white paper
Generate Sales Leads: Free White Paper - William Reed Business Media
02-Aug-2010 -
White papers (or technical papers) are one of the most effective ways to generate leads for your sales team and establish your company’s reputation as a thought leader. Want to know how to create an effective white paper? Download William...
Survey
Are you Asking the Right Questions? - William Reed Business Media
02-Aug-2010 -
Want to evaluate your company’s brand image or the opinion of the Outsourcing-Pharma readers on a certain topic? Want to perform a market research analysis without the hassle? Download William Reed Business Media’s survey brochure to find out how you...
Data sheet
Why polish and maintain tablet compression tooling? - I Holland Limited
19-Jul-2010 -
Prolong tooling life, prevent punch & die problems and increase your productivity. Read I Holland’s article on the 7 Steps of Punch and Die maintenance. This document now includes I Holland’s brand new range of high capacity ultrasonic cleaning systems.
...
On-Demand Supplier Webinar
Using hazardous chemistry at production scale - Shorter and cost-effective syntheses - Novasep
29-Apr-2010 -
Because of safety issues, hazardous chemicals such as sodium azide, diborane and diazomethane are often avoided for the large scale production of APIs, agrochemicals or fine-chemicals. Chemists typically look for alternate routes and reagents, despite the outstanding potential of these...
Data sheet
Quality assurance of pharmaceuticals - Metrohm
19-Apr-2010 -
Metrohm’s new brochure «Pharmaceutical analysis» is a highly valuable compendium to get an overview of the most important parameters determining the quality of pharmaceuticals and the methods best suited to check them.
Technical / white paper
PHARMACEUTICAL GAS ANALYSIS: A NEW TREND IN THE REGULATORY FOCUS - SGS
31-Mar-2010 -
More attention is being focused on gases role as an excipient in pharmaceutical development. Download SGS’s Technical Bulletin and learn more about cGMP monitoring and quality testing including contamination control...
Data sheet
Predictable Quality Management with Good Weighing PracticeTM (GWP®) - Mettler Toledo
31-Mar-2010 -
Operating a weighing system in compliance with any current quality management system requires a good understanding of the regulations, of the parameters influencing the measurement accuracy and of the process requirements. METTLER TOLEDO proposes a straightforward 5 step methodology combining...
Technical / white paper
Generate sales leads with a good white paper - William Reed Business Media
24-Mar-2010 -
White papers (or technical papers) are one of the most effective ways to generate leads for your sales team and improve your company’s reputation as an expert. Want to know how to create effective white papers? Download this guide now.
...
Technical / white paper
An Introduction to High-Potent API Classification - SAFC Pharma
12-Nov-2009 -
When dealing with highly potent compounds, it’s critical that failsafe procedures are in place relating to their handling, storage and containment. In order to ensure that the correct procedures are installed and adhered to, a logical system of classifying the...
Data sheet
Super Refined Excipients - Stability Enhancement and Topical Delivery of an API - Croda Health Care
30-Oct-2009 -
One of the main challenges in the pharmaceutical industry is the ability to produce stable drug formulations, and excipient purity is now believed to have an effect on this. For information on how Croda's Super Refining technology can improve drug...
Application note
Automated determination of active-substance content - Metrohm
27-Oct-2009 -
Active ingredients in pharmaceutical tablets can only be determined after several sample preparation steps. Automation with Metrohm’s 815 Robotic Soliprep speeds up sample preparation while improving reproducibility and accuracy of results.
On-Demand Supplier Webinar
Meet the requirements for GSDP for pharmaceutical products - SGS
12-Oct-2009 -
SGS
invites you to attend a free webinar to gain an overview on how to ensure the quality and integrity of your pharmaceutical products during all aspects of the storage and distribution process.
Application note
Ultrasonic Particle Engineering – The Key to Making Better MedicinesTM - Prosonix - Making Better Medicines
06-Oct-2009 -
Today the Pharmaceutical sector is focussed on ways of accelerating product commercialisation in the most efficient way possible, without compromising product quality.
This White Paper discusses how Prosonix Ultrasonic Particle Engineering Technologies can reduce time to market by controlling crystallization...
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On your radar
Globalisation
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Lifecycle management
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- Ongoing quality problems at injectables plant hurt Hospira in Q3
Counterfeiting
- Annual WHO meeting to tackle spread of substandard drugs
- FDA calls for more powers to adopt nationwide ePedigree
