We’ve got another year under our belts and we’re excited to continue bringing you the most insightful and trending stories in the pharmaceutical industry throughout 2017.

We produced nearly 200 blog posts last year and in case you missed a few, we’ve gathered the 10 most popular iSpeak posts of 2016 for you to enjoy.

FDA’s Revised Draft Guidance on Quality Metrics Has Been Issued

The US Food and Drug Administration (FDA) released on 23 November 2016 a much-anticipated revision of its draft guidance on the collection of quality metrics. The revised Submission of Quality Metrics Data Guidance for Industry is a response to both ISPE and industry concerns that the original guidance was too demanding. Read More>>

Brexit: Impact on Pharmaceutical Industry

The British pharmaceutical industry is overwhelmingly against exiting the EU. More than 50 industry leaders have warned of the regulatory and business upheaval that could result from the UK leaving, published in an open letter to the Financial Times. The executives argue leaving the EU would result in “significant regulatory burdens” and diminish the status of UK medicine institutions within the region. Read More>>

Considerations for a Corporate Data Integrity Program

Regulatory agencies, as well as industry, rely on accurate information to ensure drug quality and patient safety.  If the information associated with a drug product is not accurate, complete, or reliable, a company cannot ensure the safety and efficacy of their product for the patient.  Data Integrity therefore has become one of the hottest regulatory and compliance topics impacting the pharmaceutical industry in years.  Read More>>

Non-GMP or GMP Washers and Sterilizers Part 1 – What are the GMPs?

Automated washing systems and steam sterilizers (autoclaves) are often used in research and drug-manufacturing facilities to clean and sterilize a variety of items. Washers use water, cleaning agents, and mechanical action to remove residues from soiled laboratory and manufacturing-component surfaces. Sterilizers use steam to deactivate biological waste, sterilize cleaned laboratory and drug-manufacturing components, or terminally sterilize drug products. Read More>>

Wet Granulation Knowledge Brief

Granulation is the process of joining multiple particles or grains together, typically using a binding agent although mechanical force has been used to bond the particle together as well. This brief will provide the reader with a basic understanding of the options available for wet granulation as well as the processing implications. Read More>>

Data Entry in a Pharmaceutical Data Integrity Environment

When working with data entry forms, good pharmaceutical data integrity requires that original values be moved from memory to a durable medium as soon as possible to preserve the integrity of the values and permit creation of a complete activity history for review and release of data. This concern is expressed in a recent draft FDA Data Integrity guidance. Read More>>

Data Integrity and Your Interfaces

Interfaces typically pass data between business teams, each using that data for different functions (e.g marketing, execution, distribution, release, and testing). Fortunately, most interface failures are detectable: someone expects data that does not arrive – the incident is reported, an investigation ensues and the problem is fixed; data flows and the task moves forward. Read More>>

Introduction to EU Clinical Trial Regulation No. 536/2014

U Directive 2001/20/EC worked to simplify and harmonize the administrative provisions governing clinical trials.  It was, and remains, a good attempt but many hold the opinion that the full benefits of the directive haven’t been realized based on variations in local implementation. Read More>>

FDA Data Integrity Draft Guidance – Opportunity for Pharma Industry

Data integrity and its definition in the context of pharmaceutical manufacturing has been the subject of a lot of discussion in recent years. Manufacturing processes are highly complex, and every step generates data that must be recorded and reviewed, which is nothing new. Read More>>

Design Considerations for WFI Distillation Systems Part 1

WFI production is a critical part of any parenteral drug process. There are several factors that need to be considered when selecting WFI production methods, such as capacity, future needs, storage, and quality control. Read More>>

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