Showing items tagged as GMP

  • How to Gain Entry to Latin America’s Medtech Market

    7 August, 2018 by Julio G. Martinez-Clark, CEO, LATAM Market Access

    Don’t get bit by piranhas and crocodiles when entering Latin America’s lucrative $31 billion medical device manufacturing industry. Learn from a pro the tips, strategies and trends you’ll need to be successful in the golden medtech market in North and South America.

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  • Using a QMS to Qualify Your Suppliers

    2 August, 2018 by Sarah Beale, Staff Writer, MasterControl

    Adulterated supplements and adverse events have long been the bane of the nutraceutical industry. However, this shouldn’t and doesn’t have to be the norm. By qualifying suppliers or ingredients, nutraceutical companies not only comply with CGMPs, they also protect their customers.

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  • Regulatory Barriers to Innovation for Startups

    31 July, 2018 by Tifany Desprez, Ph.D., Communication and Marketing Manager with MasterControl European Partner, Apsalys

    France and Europe are witnessing an explosion of life science innovation from new startups. But what separates the winners from the losers? Learn how to successfully overcome regulatory barriers and get your product to market quicker.

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  • Best Practices for Supplier Evaluation and Rationalization

    26 July, 2018 by Carla Frances Reed, President, New Creed

    Pharmaceutical companies continuing the trend of mergers, acquisition and partnerships is creating challenges, opportunities and redundancies for supplier management. To meet these changing needs, it’s imperative that managers conduct supplier evaluation and rationalization processes and emphasize “good supply practices.” Learn some of these best practices and how to adapt them to your company.

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  • The Link Between Regulation, Quality Systems and Data Integrity, Part 2

    31 May, 2018 by Philippe Charbon, CEO of Apsalys, a European value-added Partner of MasterControl

    An examination of how the evolving standards of data integrity are affecting regulations and quality considerations within life science industries worldwide.

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  • Combination Products and CGMPs: What You Should Know

    27 June, 2017 by Dr. Karl M. Kapp, Department of Instructional Technology, Bloomsburg University

     At the beginning of this year, the FDA    issued final guidance for Current Good  Manufacturing Practice (CGMPs)  Requirements for Combination Products.  This guidance is for therapeutic and  diagnostic products that combine drugs,  devices, and/or biological products. This  guidance has become increasingly  necessary due to the rapid pace of technological advances in the life science industry where product types continue to merge and blur lines

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  • Brave New World: The Mutual Recognition of CGMP Inspections

    9 March, 2017 by Mark I. Schwartz, Director, Hyman, Phelps & McNamara PC

    Last week, the United States and the European Union agreed to recognize each other’s drug cGMP inspections. The agreement reached (see

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  • The Migraine Known as the Supplier Audit — and Some Simple Remedies

    23 February, 2017 Ken Christie, COO, VTS Consultants

    The topic of supplier audits can cause severe anxiety and headaches for many biopharma companies. This pain stems from the combination of having to understand the applicable regulations, determine the elements of a supplier audit in terms of criticality, establish the frequency and type of audits to be performed based on this evaluation, and follow-up on any issues found. Sufficient time is needed to prepare for and execute such activities, and time is one thing few of us have enough of. However

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  • Hacking GMPs: Deliberate Attacks or Accidental Workarounds?

    17 September, 2015 Vivian Bringslimark, President & Owner, HPIS Consulting, Inc.

    The subtitle tells it all. Most employees don’t come to work with the intention to cause harm, fail or make mistakes intentionally. Yet mistakes, errors, and failures happen. According to Sidney Dekker, author of The Field Guide to Understanding Human Error, “mismatches between written guidance and operational practice always exist”. I’s due to “the amount of increasingly tight constraints of procedures” (p.8). There have been some occasions where following a procedure could have caused a deviation if it weren’t for an astute technician who questioned the “GMP” rule. Talk about a GMP dilemma, “always follow the SOP” but don’t create a deviation either. Alas, we have a classic example of a white hat hacker.

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  • Three Keys to Successful FDA Inspections – Preparation, Management and Follow Up

    28 July, 2015 Kelly Thomas, Atlantic Validation

    Successfully completing a FDA inspection is critical to cGMP operations and commercial success. Implementing and maintaining robust quality systems is one element to accomplishing this goal. However, it is not the only element. Inspection preparation and management is another, equally important element to ensure a successful outcome. In fact, proper Inspection management techniques can help mitigate the risk of receiving an observation for compliance gaps. This article will provide insight on understanding the inspector, discuss how to prepare for and manage the actual Inspection, describe follow-up activities required for close-out, as well as describe real-life lessons learned.

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  • Tales from the Front

    9 June, 2015 Morris Sherwood Director, Regulatory Affairs and Quality Assurance Isolite Systems

    So far in my 26 years of working in medical devices I have had many an adventure when it comes to FDA and Notified Body Inspections. I love inspections. I know it sounds crazy but there is this Zen place you get to during an inspection. You must practice patience. You must not think you know exactly what your inspector is thinking. At the same time, it is this amazing game of psychological chess whereby you watch your opponent’s moves and think five moves ahead, only to have your strategy thrown out the window when the inspection zigs rather than zags.

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  • Don’t Call Me Jim Cramer but Here are My Top 5 Pharma Trends

    3 June, 2015 Lane Hirning, Product Management Director, MasterControl Inc.

    Judging by a recent report forecasting future growth, the pharmaceutical industry is thriving despite the recent economic downturn. A market research firm is estimating a 30 percent increase in global medicine spending by 2018, which is great news for the industry (1). The same report cited the anticipated launch of 200 new revenue-boosting drugs within the next five years.

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  • The ISO 9001: 2015 Change Train is Gathering Steam

    6 May, 2015 Robyn Barnes, Marketing Communications, MasterControl

    ISO change is coming your way in the form of an ISO 9001 update.  This is a major revision to the standard and pharma companies need to prepare to jump on this train. 

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  • Draft Guidance on Good Manufacturing Practices for Combination Products – FDA Delivers on Promises

    18 February, 2015 Suzanne M. O'Shea, Counsel, Faegre Baker Daniels LLP

    Two years ago, in January 2013, FDA published the final regulations on Good Manufacturing Practices for Combination Products.[1] These regulations are built on the concept that the constituent parts of a combination product retain their regulatory identity as a drug, device, or biological product, even after they are physically, chemically, or otherwise combined into a single-entity combination product (i.e., prefilled injector or drug eluting stent) or co-packaged together.[2] Therefore, all the good manufacturing requirements associated with each constituent part must be complied with in the manufacture of single-entity and co-packaged combination products.

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  • Understanding the Relationship between GMPs and Adulteration

    25 September, 2014 Marc C. Sanchez, Contract In-House Counsel & Consultants, LLC

    Good Manufacturing Practices (GMPS or cGMPS) are a bit of a misnomer. The name implies the practices only apply to manufacturers, but the limitation is in name only. It suggests a rigid system of procedures more suitable for multinational corporations than start-ups, mid-size companies, or importers. In truth GMPs are policy goals that do not specify how an activity is done, just the result it should achieve. The name also lacks any link back to the overarching purpose of the practices. GMPs are not a scoring or rating system. Instead GMPs are a crucial link to avoiding adulteration and ensuring quality. The practices set a floor or safety net of minimum facility sanitation practices to ensure cosmetics are not indirectly contaminated. It also establishes a consistency that secures quality. GMPs are oft cited by the FDA following facility inspections in Form 483s and Warning Letters because it provides a window into the culture and compliance mindset of a facility. That mindset suggests the likelihood of adulteration or larger compliance violations.

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  • Regulatory Records Primer Part 1: Decoding the Requirements for Medical Device Manufacturers

    21 August, 2014 Les Schnoll, Quality Docs, LLC

    The Quality System Regulation (QSR) is premised on the theory that the development, implementation, and maintenance of procedures designed to carry out the requirements of the regulation will assure the safety and effectiveness of medical devices. Therefore, it is easy to see the importance of the records required to document the implementation of those quality system procedures. One of the basic themes of the Quality System Inspection Technique (QSIT) (used during inspections of medical device manufacturers) is the “Establish Test.” The QSR requires many procedures to be “established” and defines “establish” as “define, document (in writing or electronically), and implement.”

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  • Why Food Makers Are Investing In Food-Safety Software

    16 October, 2014 Sam Lewis, Associate Editor, Food Online

    Throughout 2014, food makers have put forth significant efforts in pursuit of food-safety and quality-management software solutions. But why is there so much interest and effort in these systems now?

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  • Choosing the Right Drug Name: How to Increase Your Chances for Approval

    4 September, 2014 Susan M. Proulx, President, Med-ERRS

    The pharmaceutical industry is all too familiar with how exceedingly challenging it can be to achieve a viable trademark that is accepted by the health authorities, especially if obtaining a global mark is the end goal. Over the past few years, health authorities in several countries have been developing their proprietary name guidances. In the last six months alone, both Health Canada and the FDA released guidances pertaining to proprietary name development – Health Canada’s proprietary name guidance was finalized and FDA released its first-ever initial draft guidance on the topic of name selection and development. Industry is now curious to learn how these guidances will affect their current trademark development and selection process and their trademark’s chance of approval.

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  • Quality’s Role in Drug Approvals

    12 June, 2014 by Theresa Allio, Ph.D.

    In a recent review, I summarized the underlying reasons contributing to delayed market entry for 51 product applications submitted to CDER between 2009 and 2012.1 Reasons cited in the complete response letters issued for these applications covered a number of areas, including safety, efficacy, regulatory, labeling and quality related issues. Quality- related issues were one of the most prominent reasons for delay of market entry with deficiencies being cited in 20/51 (39%) of applications. GMP inspection failures and data deficiencies contributed equally to the quality citations. The prominence of quality-related issues in the delay of product approvals emphasizes the importance of robust quality programs in drug development. Understanding what elements have posed as hurdles in past development programs will help a sponsor avoid these pitfalls in the future.

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