FDA Clarifies Human Subjects Protection Expectations

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A new guidance from the U.S. Food and Drug Administration (FDA) provides welcome direction to sponsors, investigators, and institutional review boards (IRBs) on human subjects protection.

The guidance is one of the agency’s follow-ups to its revisions of the “Common Rule” (Federal Policy for the Protection of Human Research Subjects), which became effective in July 2018. General compliance for the revised Common Rule is mandated to begin in January 2019. The purposes of the Common Rule are to promote “uniformity, understanding, and compliance with human subject protections and to create a uniform body of regulations across federal departments and agencies,” FDA explains in the new guidance.

The requirements contain several new areas of informed consent, including changes relating to the content, organization, and presentation included in the consent form. It also clarifies the process to facilitate a prospective subject’s decision about whether to participate in research. FDA is clarifying the provisions to help sponsors and investigators develop, and IRBs implement, two separate informed consent forms.

The guidance also follows up on earlier FDA rules which allowed IRBs to use expedited review procedures for certain kinds of research involving “no more than minimal risk.” The new guidance includes a list of categories that may qualify for the fast track, while it also makes clear that, as appropriate, IRB reviewers must find that the research on the list involved no more than minimal risk.

The Link Between Quality Metrics, Data Integrity, and Quality Culture

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Data Integrity continues to be one of the hottest topics in our industry and for very good reason. Without the necessary systems and/or processes in place to ensure data integrity throughout the product lifecycle, product quality and patient safety issues are more difficult to detect and therefore mitigate in a timely fashion.

It is important to understand what data integrity really means in order to be compliant. Essentially, it refers to the fact that data must be reliable and accurate over its entire lifecycle. Data integrity and data security go hand in hand, even though they’re separate concepts. Uncorrupted data (integrity) is considered to be whole and then stay unchanged relative to that complete state.

Quality metrics, quality culture, and data integrity are of particular concern to both the industry and regulatory authorities. Pharmaceutical Online has published an interesting history of how these three areas have come together in establishing current global regulatory expectations.

Read the article here.

API Development: 5 Critical Mistakes to Avoid

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Less than ten percent of drug development programs successfully reach the commercial marketplace. Most organizations strive to produce as many effective compounds as possible to increase the chances of commercialization. In order to avoid major challenges later during commercial scale-up, personnel from Development, Manufacturing, Quality Control and Quality Assurance should be aware of critical mistakes that can occur during the early development phase.

Learn more about these challenges from this article at Pharmaceutical Online.

August 10, 2018 FDA Warning Letter to Kyowa Hakko Bio Co., Ltd.: Failure to ensure the API manufactured at the above-mentioned facility are in compliance with CGMP

MDSAP: Are You Ready?

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ISO 13485:2016 is the internationally agreed upon standard that outlines the requirements for a quality management system (QMS) specific to the medical device industry. This standard will be fully implemented by 2019. New rules and revisions to existing requirements apply throughout the QMS, especially for those organizations managing vast networks of suppliers and vendors. Key areas/processes impacted are document control/management, change management, supply chain, and product lifecycle. Additionally, device usability and post-market surveillance requirements will all be affected.

Learn more from the resources below:

Looking for more support and guidance with respect to MDSAP inspection readiness? Contact MWA today.

The Drug Supply Chain Security Act: Is Your Supply Chain Secure?

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Supply Chain

Managing the Drug Supply Chain is complex and challenging for any organization. Risks associated with supply disruptions and drug shortages have the potential to impact patient’s lives. With the introduction of the Drug Supply Chain Security Act (DSCSA), all players within the pharmaceutical industry are confronting the challenge of implementing a serialized drug tracing system with little guidance on data standards, roles, or accountabilities.

“The Drug Supply Chain Security Act (DSCSA) is a federal standard that “outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States,” according to FDA.

“The DSCSA is more than a rule… It is a global mandate, requiring any company wishing to sell a pharmaceutical product in the U.S.A. to facilitate product ‘traceability’ by 2023. In theory, this means a consumer should be able to pick up a bottle at a pharmacy and see all the hands that touched it prior to the point of sale.”

Read more about the three distinct stages of implementation (Product verification, Serialization, and Traceability).

ASQ 2018 Conference Update

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Raj Chawla and Lisa Helmonds at ASQ 2018
Raj Chawla and Lisa Helmonds at ASQ 2018

MWA Consulting attended the American Society for Quality (ASQ) 2018 World Conference on Quality and Improvement in Seattle, WA April 30 – May 2, 2018. This year’s theme was “The Innovation of You”, focused on encouraging quality professionals to harness and embrace the “exponential pace of change” experienced today by organizations and individuals.

If you are an ASQ member you can access most of the conference content through the ASQ website.

We attended several sessions which contained valuable insights related to quality improvement; we’re sharing some of our notes here. Enjoy!

FDA Draft Guidance on Compounding at Outsourcing Facilities

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shutterstock_123231109 (1)

Does your company compound drugs at outsourcing facilities? To address the use and qualification of bulk substances in compounding, the FDA issued the draft guidance document: Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act: Guidance for Industry (March 2018).

The proposed rules identify outsourcing facilities as its own category, which is separate from traditional compounders. This draft guidance is an extension of The Drug Quality and Security Act (DQSA), which was passed in November 2013. It asserts that Active pharmaceutical ingredients (APIs) must be accompanied by a monograph from an appropriate governing party (if one exists), must be made in a facility that has prior approval, and have a certificate of analysis to prove they been characterized.

Download the guidance here.

EC Draft Revision to Annex 1 “Manufacture of Sterile Medicinal Products”

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The European Commission released a draft revision to Annex 1 “ Manufacture of Sterile Medicinal Products” on December 20, 2017.  The revisions have several major changes that will impact your sterile products and drug substance manufacturing.  This revision introduces Quality Risk Management for use with new technologies and processes and includes updates to the recommendations on clean rooms, sealing technologies and single-use systems. It also includes a new section on “Utilities” covering water, sterilization, filtration and cooling systems used for production of sterile products.  The draft is available for public comment until March 20, 2018.

Download the complete draft here.

Make comments here.

FDA 483 Observations from 2017

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Happy New Year! MWA is off and running to a busy 2018. Our feature article for January 2018 is a summary of FDA 483 observations from 2017. This information can help you focus your resources to ensure your company is in compliance with the current FDA regulations and concerns as well as enhance your training programs.


Here is the complete spreadsheet of observations from the FDA website (link will download as an Excel file) from Fiscal Year 10/1/2016 – 9/30/2017. It includes summaries for Biologics, Bioresearch Monitoring, Devices, Drugs, Foods, Human Tissue, Parts 1240 and 1250, Radiological Health and Veterinary Medicine.

MWA’s regulatory compliance consulting experts can help you formulate the correct response to FDA 483 observations. Our staff includes highly experienced subject matter experts who can help your firm craft a clear and accurate response to technical inquiries for GXP reviewers as well as warning letters and technical questions to Regulatory Agency centers. Responding to a Regulatory Agency is only the first step. MWA will also provide you with a clear remediation and corrective action plan and help you implement the specific actions quickly and efficiently.

For Drugs, the most common violations were related to Production Record Review; Organization and Personnel: The QC Unit and Personnel Qualifications; Laboratory Controls; Production and Process Controls: Written Procedures Deviations and Control of Microbial Contamination.

For Devices, the most common violations were Corrective and Preventive Action; Records: Complaint Files and Device History Records; Production and Process Controls, Process Validation; Design Controls, Design Validation; Quality System Requirements, Quality Audits; and Purchasing Controls.

The full summary can be found on the PDA website.

Recent News and Guidelines


Data Integrity is ‘Mission Critical,’ FDA Enforcer Says

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From QMN Weekly Bulletin, November 10, 2017

Ensuring data integrity is a crucial task for drug manufacturers wishing to stay out of trouble with the FDA, a top enforcement official at the agency told an industry conference.

Titima Ongkantong/
Titima Ongkantong/

“Everything else that we do is based on the integrity of the data,” Douglas Stearn, the director of the Office of Enforcement and Import Operations in the Office of Regulatory Affairs, said at the 12th annual FDA Inspections Summit, sponsored by FDAnews. “When you’ve got this problem, you’ve got a very big problem.”
The FDA views data integrity as a good manufacturing practice issue, and the agency can determine that a product is adulterated if it uncovers evidence of falsification, manipulation or concealment of data about test results, batch processing or other operations, Stearn said.

Sometimes companies land in hot water over issues that can seem “shockingly small,” such as falsification of work records to generate unearned overtime payments, which can raise questions about overall control of the information system. Managers may be unaware of these problematical practices, so accountability is key, he said.

“Innocent people can be put in a bad place,” Stearn said. “Your system should be able to tell who’s on it, and doing what.”

In the years after the Hatch-Waxman act was passed in 1984, the generic drug industry was hit by scandals that still cast a shadow over the FDA’s policing of data integrity, Stearn said. Companies manipulated data to move their abbreviated new drug applications to the front of the line, and in one case, an FDA reviewer was prosecuted for taking payoffs, Stearn said.

Data integrity enforcement is changing as more records are computerized and more foreign companies join the drug supply chain, he said. It can be difficult for the agency to prosecute violators abroad because of the absence of subpoena power and different practices regarding court summonses and evidence, Stearn said. Another check on American enforcement clout in India and China, the largest overseas drug producers, is the lack of extradition treaties between those two countries, respectively, and the United States, he said.

Stearn pointed drug manufacturers to two reference sources for data integrity guidelines:

FDA regulations, which include requirements such as “backup data are exact and complete,” data is “secure from alteration, inadvertent erasures, or loss”, certain activities are “documented at the time of performance” and that a company maintain “complete records of all tests”.

• The FDA’s 2016 draft guidance, “Data Integrity and Compliance With CGMP”.