Data Integrity: The Roadmap to Compliance

MWA is offering a new, comprehensive training program on Data Integrity, available for onsite presentation at your company.

Data integrity is critical for ensuring safety, efficacy, and quality of drugs and the quality of data produced during clinical trials and as part of the Application Integrity Process (AIP).

This interactive workshop, which can be customized to meet your needs and schedule, will include the following topics:
  • Key Terms and Concepts
  • Regulatory Requirements and Considerations
  • Training and Self Audits
  • The Roadmap to Compliance: Management Governance, Culture, Risk Assessments, Data Governance, Technology and Validation, Procedures and Processes, FDA Warning Letters, ALCOA+

To learn more about scheduling and pricing for the Data Integrity Training Program at your site, please contact Lisa Helmonds at 866-497-7787, ext. 5 or email lisa@gxpsrus.com.

Guideline on Process Validation for Manufacturing of Biotechnology-Derived Active Substances

Are you up to date on process validation requirements for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submissions for the EU?  Process validation is the documented evidence that the process, operated within established parameters, can perform effectively and reproducibly to produce an active substance or intermediate meeting its predetermined specifications and quality attributes (ICH Q7).

The EMA just published a new guideline that addresses the data requirements for process characterization and verification for submission of a marketing authorization application or variation.

These principles apply to recombinant proteins and recombinant polypeptides, their derivatives, and products of which they are components (e.g. conjugates). This guideline discusses process characterization and process verification requirements.  It also includes points to consider such as evaluation and verification of the upstream and downstream processes, issues related to single use equipment and multiple harvests, reprocessing, hold time, storage, transportation, and multi-facility production.

Download the full guidance here.

Comparability Protocols for Human Drugs and Biologics: Guidance for Industry

How do you handle post-approval changes to your products?  New draft FDA guidance document establishes a framework to ensure you effectively use your product and process knowledge and understanding to prepare a Comparability Protocol that employs the tools in ICH Q8 to Q11.  It also provides guidance on a robust control strategy, incorporates risk management over the product’s life cycle and describes elements of an effective pharmaceutical quality system.

Learn more and download the guidance here.

Good Distribution Practice and Supply Chain Integrity

Do you have control over your supply chain?  Qualification of suppliers is critical to ensure only authentic products are distributed.  To ensure confidence:

  • the authorized supplier must have a manufacturing or wholesale dealer license
  • the authorized supplier must comply with current good distribution practices (GDP); and
  • you should perform periodic due diligence checks.

For additional guidance, check out this article from the Medicines and Healthcare Products Regulatory Agency (MHRA).

 

Final FDA Human Factors Guidance

Did you know that the primary reason for device recalls is due to poor design control?  This guidance document (“Applying Human Factors and Usability Engineering to Medical Devices” published Feb. 3 2016) is critical for both device and combination product manufacturers. It can help you establish the path for ensuring that the design of the medical device or the drug delivery system has been developed with human factors in mind to minimize potential use errors and resulting harm.  Understanding how the user interface design affects interactions people have with technology and the environment where device is used can ensure the products form, fit and function addresses patient needs.  This guidance includes a template of the outline and content expected of the human factor report that should be issued for each device going to market, considerations for determining sample sizes for human factors validation testing, and guidance on analyzing results of human factors validation testing.

Learn more and download the guidance document here.

Data Integrity and Compliance With CGMP

How does your company handle GXP data?  CGMP violations involving data integrity have been increasing over the last few years.  Data integrity is an important component to ensure safety, efficacy, and quality of drugs.

This guidance document is critical for all pharmaceutical, medical device and biotechnology companies to help establish robust data handling policies and procedures. It clarifies data integrity definitions, discusses when to retain original documents, describes how to handle electronic data, when it is permissible to exclude CGMP data from decision making and much more.

Learn more and download the guidance document here.

FDA and NIH Clinical Trial Protocol Template Documents Updated and Available for Public Comment

FDA and NIH have updated the clinical trial protocol template for Phase 2 and Phase 3 IND (investigational new drug / investigational device exemption) studies.

Public comments can be submitted by April 17, 2016 via a form found on the NIH Office of Clinical Research and Bioethics Policy website under the Clinical Trial Protocol Template Documents section.

Download the protocol template shell here.

Download the instructions here.

Submit public comments on these new templates here.

Lisa Helmonds Joins MWA as Vice President

MWA Consulting, Inc. is pleased to announce that Lisa Helmonds will join the MWA team as Vice President on April 1st, 2016.

“With over 30 years of industry training within the areas of Manufacturing and Quality Assurance in the pharmaceutical and medical device industries, Lisa brings significant experience and leadership to the MWA team,” says Bill Daniels, CEO. “In her new role as Vice President, Lisa will focus on developing, maintaining and growing the relationships with MWA’s clients, increasing the number of highly-qualified MWA associates, implementing training programs, and ensuring that MWA continues to offer the highest quality GXP consulting services in the industry.”

Lisa’s prior professional history includes over 13 years as an independent consultant/associate with Marion Weinreb & Associates, Inc. which became MWA Consulting in January 2016. Lisa has extensive GXP knowledge, understands the complexities of large companies and the challenges of start-ups. She holds a BS in Zoology from the University of Rhode Island and an MBA from Santa Clara University.

“I am honored to be working with Lisa in this next phase of MWA’s development,” says Marion Weinreb, President of the new corporation, and an active member of the consulting team.  “Lisa brings a wealth of knowledge to MWA and embraces the values that management and the members of the MWA team demonstrate in their high touch interactions with clients, and in the consulting services that we provide.”

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ABOUT MWA CONSULTING, INC: Formerly Marion Weinreb & Associates, Inc., MWA is a dynamic consulting and staffing organization with expertise in GXP (GCP, GLP and GMP) compliance. We ensure that pharmaceutical, biotechnology, and medical device companies efficiently meet and exceed their compliance goals from development through commercialization.  Website: www.gxpsrus.com. Phone: 866.497.7787.

Best Practice Guide for Quality Agreements Published by Rx-360 Working Group

This is one of the most practical guides published to assist companies in setting up quality agreements with their suppliers.  It contains practical information, attempts to identify best practices, embraces and encourages sample language and provides common sense solutions to typical issues that come up during the quality agreement process.

Rx-360 is a not for profit consortium led by volunteers from the Pharmaceutical and Biotech industry including both manufacturers and suppliers.  The purpose is to enhance the security of the pharmaceutical supply chain and to assure the quality and authenticity of the products moving through the supply chain. The organization’s mission is to protect patient safety by sharing information and developing processes related to the integrity of the healthcare supply chain and the quality of materials within the supply chain.

Download the entire guide here.

Hackers Trying to Steal Drug Formulas for Counterfeiters Can Wreak Havoc

IT expert advocating for stronger pharma IT security.

This article highlights the threat that hackers and cyber-criminals pose to drug and device manufacturing systems.  MWA assesses the security of your IT systems during audits, particularly those that consider Part 11 compliance.  If you feel that your organization is protected, read this article and share it with your IT personnel.  You may want to reconsider your conclusions.

Criminals can manipulate drug production if IT systems not protected says expert

By Gareth MacDonald+, 02-Mar-2016

Hackers trying to steal drug formulae for counterfeiters can wreak havoc says an IT expert advocating stronger security for networked pharmaceutical manufacturing facilities.