The concept of quality oversight is increasingly used in the context of GMP-compliant production operations. It represents the quality understanding of a pharmaceutical manufacturer as well as the involvement and responsibility of management. In this context, it includes the quality systems implemented to enable compliance with internal and regulatory specifications and regulations. The author reviews operative options for the implementation of a quality oversight and how companies can benefit from this function from a regulatory perspective.

BioPharm International's Outsourcing Resources 2018 

	When referring to this article, please cite it as P. Hoersch, "Quality Oversight During Sterile Filling Operations," 

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Articles

Features

The author reviews operative options for the implementation of a quality oversight and how companies can benefit from this function from a regulatory perspective.

Quality Oversight During Sterile Filling Operations

FDA finalized its guidance on contract manufacturing, 

Contract Manufacturing Arrangements for Drugs: Quality Agreements

, in November 2016 (1). This document explains how parties that engaged in contract manufacturing can use quality agreements to delineate their roles and ultimately ensure compliance with current good manufacturing practice (CGMP).  
	
	In the months since FDA finalized this guidance, how has industry responded? Are manufacturers that establish contracts for specific manufacturing activities using quality agreements effectively? The answer is mixed; yes, many are, but there is room for improvement. In this article, the authors cover the scope and legal underpinnings of the guidance, as well as what FDA investigators may consider regarding a quality agreement during an inspection. The article also provides some examples of issues related to quality agreements that FDA has called out in warning letters since the guidance was finalized.


	Vol. 31â¨
	March 2018â¨
	Pages: 16–21

	When referring to this article, please cite it as P. Katz et al., "Good Quality Agreements Support Compliance with CGMP," 

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Drug manufacturers can improve use of quality agreements in contract manufacturing.

Good Quality Agreements Support Compliance with CGMP

Improvements in analytical technologies provide increased capabilities to examine proteins, cell lines, raw materials, and drug product throughout the drug development and manufacturing process. Regulatory expectations have also evolved. These new analytical requirements can tax the resources and technical capabilities of drug companies. 

	Contract testing laboratories, which traditionally provided specialized testing services and expertise, are playing new roles in the current biopharmaceutical development market. To gain insight on what sponsor companies can gain from outsourcing their analytical processes, 

 spoke with Jure Kapetan, managing director Eurofins BioPharma Product Testing D/A/CH; Wei Pan, director strategy and analytical CMC, development and analytical services at Catalent Pharma Solutions; and Michael Merges, director of strategic growth, biologics analytical services, at Catalent Pharma Solutions.

	When referring to this article, please cite it as S. Haigney, "Gaining Analytical Insight in the Development of Biologics," 

Contract testing organizations can provide bio/pharma companies with a cost-effective way to adapt to new technologies and regulations.

Gaining Analytical Insight in the Development of Biologics

Biopharmaceutical contract service providers have advanced their capabilities and offerings to help their clients tackle industry challenges and accelerate innovations. The author explores some of the latest investments in facilities and equipment by contract service providers, as well as the mergers and acquisitions market.

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	When referring to this article, please cite it as A. Lowry, “Contract Services Investment Update," 

BioPharm International Outsourcing Resources 2018 

A review of the latest investments in facilities, equipment, and acquisitions by biopharma contract service providers.

Contract Services Investment Update

When it comes to outsourcing process validation of biologics, Abel Hastings, director of process sciences at FUJIFILM Diosynth Biotechnologies, says that the relationship between a contract development and manufacturing organization (CDMO) and sponsor is key in ensuring successful process validation.  “Customers that are open about their strategy, their data (good and bad), and their own strengths and weaknesses are most successful.” 
	
	

 spoke with Hastings about the specific challenges that arise in the process validation of biologics. 
	 


	â¨Vol. 31â¨
	March 2018â¨
	Pages: 22–23

	When referring to this article, please cite it as S. Haigney, "Process Validation in Biologics Development," 

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Process validation is an extension of biologics development processes. 

Process Validation in Biologics Development

Digital technologies and information sciences have helped advanced medical science and research, a lesson that was obvious to Dr. Tae Han Kim, CEO and president of Samsung BioLogics, when he was researching new business areas for Samsung about 10 years ago. His recommendation-to enter the biologics drug contract manufacturing market, an area in which it had no prior experience-leveraged the company’s manufacturing and plant construction expertise and has provided the company a competitive edge, he says, in the contract manufacturing market.

BioPharm International's Outsourcing Resources 2018

	When referring to this article, please cite it as R. Peters, “Bigger is Better in Samsung’s Approach to Biomanufacturing," 

A different perspective on controlling fixed costs of biomanufacturing, based on know-how from other industries, provides a competitive edge, says the CEO of Samsung BioLogics. 

Bigger is Better in Samsung's Approach to Biomanufacturing

Criteria for choosing an analytical services partner during the early phase of drug development include scientific skills/knowledge and resource availability, and the type of relationship developed with an analytical service provider is typically defined by customer needs. To start with, the provider of early phase analytical studies should show that they have the necessary scientific skills and knowledge to support the program in question. Discussions between client and provider are also necessary to ensure that both parties are comfortable with what is required out of the relationship.

BioPharm International's Outsourcing Resources 2018 eBook

	When referring to this article, please cite it as F. Mirasol, " Choosing an Analytical Partner in Early Drug Development," 

Successful outsourcing relationships for early phase analytics in drug development are driven by partnership.

Choosing an Analytical Partner in Early Drug Development

Competitive pressures have led to explosive growth in demand for research and development (R&D) outsourcing, especially as smaller biopharma and pharmaceutical companies play a more prominent role in drug development. Pharmaceutical manufacturers, especially small- to mid-sized companies, are discovering that partnering more closely with one diversified contract company can reduce development time and cost.

	When referring to this article, please cite it as A. Shanley, “Outsourcing: Does Focus Pay Off?," 

BioPharm International Outsourcing Resources 

Research suggests that working with a single contract partner can reduce development time and improve economics.

Outsourcing: Does Focus Pay Off?

Complete response letters (CRLs) have become a powerful way for FDA to push drug developers to improve their product and process understanding during early development phases. By pointing out failures discovered during FDA plant preapproval inspections (PAIs), whether issues involving current good manufacturing practice (cGMP) compliance or methods used to establish product safety or efficacy, CRLs stop the approval process until those problems are remediated. For companies that have received them, CRLs have resulted in significant loss of investor confidence and tumbling stock prices.

	When referring to this article, please cite it as A. Shanley, “Avoiding Complete Response Letters," 

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CRLs put the brakes on drug development and damage corporate reputation and stock prices. Upfront investment and better sponsor oversight are ways to prevent them.

BioPharm International-03-15-2018