This interview with Patricia Santos Serrao, director of clinical and regulatory solutions, and Matt Lowe, executive vice president of Master Control, discusses the roots of problems with corrective and preventive action (CAPA) and documentation of standard operating procedures (SOPS), and how Quality Management Systems (QMS) software is being improved to address them, and to make it easier to collaborate and communicate with contract partners.

Articles

Features

Advances in cloud-based IT and user interfaces make it easier to collaborate, but a strong foundation, based on knowledge of data and risk management principles, is needed first.

Extending QMS to Contract Partners

The half-cycle method for validating sterilization, although necessary in its original context of ethylene oxide sterilization, can have adverse effects on materials if used for steam sterilization.

	The author describes some of these potential results and reviews historical and current thinking on validation of sterilization processes.

The half-cycle method for validating sterilization can have adverse effects on materials if used for steam sterilization.

Too Much by Half: Misapplication of the Half-Cycle Approach to Sterilization

Every biopharm company conducts investigations for undesirable outcomes related to safety, quality, and reliability of product and processes. The question is to what degree do these investigations support or hinder performance excellence?

	A sub-team that was formed as part of the BioPhorum Operations Group (BPOG) human performance workstream sought to answer this question. The findings suggest that biopharm is behind other industries with respect to investigation best practices.

	This article provides a pathway for the industry to improve its investigations, and in so doing, improve overall organizational learning and performance.

Are investigations supporting or hindering performance excellence?

Investigation Effectiveness Drives Human Performance Excellence

PDA’s first aging facilities survey suggests that post-approval changes play a major part in slowing pharmaceutical industry investment in new technology. Fewer pharmaceutical companies even do “technology scouting” today.

	Maik Jornitz, who chaired the aging facilities taskforce during its first year, discusses challenges and what is required for change.

PDA’s first aging facilities survey suggests that post-approval changes play a major part in slowing pharmaceutical industry investment in new technology.

Is Global Regulatory Gridlock Slowing Modernization?

In InstantGMP, cloud-based IT and an approach grounded in cGMPs, brings more of the power of paperless recordkeeping to manufacturers, at a fraction of the cost.

	CEO Rick Soltero, who worked In quality, manufacturing and R&D before establishing the company, talks about the challenges facing small-to-mid-sized pharma companies in modernizing their recordkeeping systems, and how important it is that solutions be grounded in cGMPs. 

Paperless Batch Records for the Masses

A new website and methodology would rank manufacturers based on quality and good manufacturing and business practices.  Martin Van Trieste discusses the principles behind medicine-i.com, which he has started up, using software designed by Richard Love, CEO of HarborView. 

	The site will be driven by algorithms that take quality, compliance and shortages data and rank suppliers based on their level of control in each area.

Could greater market transparency improve pharmaceutical quality and regulatory compliance?

Could Greater Transparency Improve Pharmaceutical Quality and Compliance?

Gelatin is commonly used for drug encapsulation. Ensuring that materials have optimal critical quality attributes for the required formulations is crucial, as are practices that will ensure an uninterrupted supply of quality material.

	Jean-Philippe Talmon, chief procurement officer at Capsugel, shares best practices, for both natural and synthetic materials.

Ensuring that materials have optimal critical quality attributes for the required formulations is crucial.

Ensuring Quality in Pharmaceutical Raw Materials

Effective microbiological testing during biopharmaceutical drug development and manufacturing is crucial for ensuring sterility, determining antimicrobial effectiveness, detecting microbial contamination or bioburden levels, analyzing endotoxins, and implementing environmental monitoring programs.

	Growing pressures to increase productivity, flexibility, and cost-effectiveness and the unique properties of many next-generation therapies are challenging today’s microbiologists.

Pressures to accelerate current and next-gen therapies are challenging traditional microbiological testing models.

Pharmaceutical Technology-11-15-2016