FEATURED ARTICLES

  • What Should You Do After An FDA Inspection?
    What Should You Do After An FDA Inspection?

    The FDA inspected your firm, and one or more FDA Form 483 inspectional observations were noted by its team. This article provides guidance on how to minimize or avoid additional enforcement actions.

  • Beyond Human Error: Are Blunt- Or Sharp-End Decisions More Important In The Life Sciences?
    Beyond Human Error: Are Blunt- Or Sharp-End Decisions More Important In The Life Sciences?

    Decisions made upstream in the supply chain can have enormous repercussions downstream at the bedside or in the home, where medications are administered. How do we guarantee that the big and seemingly small decisions being made with each batch manufactured will be the “right” ones when there is so much inherent variability around us?

  • Pharma Industry Braces For A No-Deal Brexit
    Pharma Industry Braces For A No-Deal Brexit

    Chaos reigns supreme in London at the moment, as British Prime Minister Theresa May struggles to find a graceful way for the United Kingdom to exit from the European Union (EU). Meanwhile, pharmaceutical manufacturers must prepare for multiple potential outcomes, including a “no-deal” (or “hard”) Brexit.

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WHITE PAPERS & CASE STUDIES

  • ICH Q12 Updates: Increasing Predictability And Efficiency Of Post-Approval Changes
    ICH Q12 Updates: Increasing Predictability And Efficiency Of Post-Approval Changes

    Through proper implementation of ICH Q12 tools and enablers, the industry could manage CMC changes effectively under a company’s pharmaceutical quality system with less need for extensive regulatory oversight prior to implementation.

  • 6 Regulatory Changes Affecting Bioprocessing In China
    6 Regulatory Changes Affecting Bioprocessing In China

    This article outlines six recent regulatory changes in China intended to protect patient safety as well as reduce regulatory burdens and minimize delays.

  • Critical Considerations About The Future Of Global Cell Culture Bioprocessing
    Critical Considerations About The Future Of Global Cell Culture Bioprocessing

    In today’s changing industry, it is critical we consider several factors about cell culture bioprocessing and the impact they will have on the future of patient treatment.

  • Is Your CMO Ready For Serialization And Aggregation?
    Is Your CMO Ready For Serialization And Aggregation?

    While some are waiting for mandates for traceability, serialization, and aggregation, others are recognizing the inevitability of these strategies. Does your CMO have a dedicated traceability operation within the company and serialization efforts in place?

  • Avoiding HPAPI Contamination
    Avoiding HPAPI Contamination

    Strict regulations regarding the manufacture of HPAPIs require that pharmaceutical companies and contract manufacturing organizations (CMO) carefully select equipment, outline processes and deploy appropriate containment strategies. Read how partnering with a knowledgeable and experienced CMO for this important stage of a drug’s life cycle can reduces costs and timelines, and ensures the safety of employees, the environment and the patient.

  • Using A CMO To Streamline Process Characterization
    Using A CMO To Streamline Process Characterization

    While traditional small molecule drug products usually consist of pure chemical substances that are easily analyzed after manufacture, biologics such as monoclonal antibodies (mAbs) are much more complex. Without thorough and comprehensive testing data a biologics license application (BLA) for the manufacture of a biopharmaceutical for commercial distribution will invariably be denied by regulatory bodies such as the US FDA. AbbVie’s five-step process results in a thorough understanding of the biologic and process control strategies to ensure drug safety, purity, and potency at the commercial scale, and since it is much harder to implement changes post- commercialization, continued process validation is employed.

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PRODUCTS & SERVICES

Pharmaceutical Compliance Packaging Pharmaceutical Compliance Packaging

Pharma Packaging Solutions helps companies create packaging which deals with dosing regimens, patient instructions, patient record keeping and more. For companies needing unique designs to drive medication adherence, there is in-house Creative Service Team to develop specified artwork.

Pharmaceutical Environmental Humidity and Temperature Probes: HygroClip2 Pharmaceutical Environmental Humidity and Temperature Probes: HygroClip2

The HygroClip2 ADVANCED humidity and temperature probes offer you maximum repeatability and an accuracy of ±0.8 %RH and ±0.1 K.

Enterprise Asset Performance Management Software for Life Sciences, Pharma Enterprise Asset Performance Management Software for Life Sciences, Pharma

Technology, enabled by the Industrial Internet of Things (IIoT), is empowering organizations to shift to a holistic and operations-centric view where proactive and predictive maintenance (PdM) enables front line personnel in life sciences to act before costly failures occur.

Life Sciences Regulatory Compliance Services Life Sciences Regulatory Compliance Services

The Schneider Electric team of dedicated industry experts is focused on providing companies with strict regulatory adherence in a timely and cost-effective manner. This includes comprehensive regulatory compliance and validation services, focused on but not limited to, environmental monitoring systems, building management systems, manufacturing, processing and packaging equipment and automated business systems (MES, laboratory, Information Technology). The Schneider Electric offerings also include quality audits and assessments. Our full range of services and solutions are vendor and platform independent, providing organizations with an objective and authoritative view.

USP 232 And USP 233 Elemental Impurities Compliance USP 232 And USP 233 Elemental Impurities Compliance

Metrics Contract Services offers a complete elemental impurities program designed to comply with the USP 232 and USP 233 Elemental Impurities proposed chapters which become official on December 1, 2015.

Logistics Audit/Assessment & Engineering Solution Services

Modality Solutions provides services such as: cGMP readiness assessments, product characterization and stability studies for distribution, controlled-environment logistics process validation, quality management systems and change control, and thermal packaging design and qualification.

Powder Transfer Process Powder Transfer Process

EZ BioPac is meeting the challenges of biopharmaceutical powder manufacture. The EZ BioPac single-use system is the fastest, most efficient solution. Its larger diameter top opening permits easy filling and fine-tuning of final weight. 

Regulatory Services Regulatory Services

If you need help preparing and submitting your API regulatory applications, Cedarburg Hauser Pharmaceuticals has the knowledge and experience it takes to efficiently guide you through the complexities of the FDA submission process.

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LIFE SCIENCE WEBINARS

  • Standing Out In The Crowded Biopharmaceutical Contract Manufacturing Market
    Standing Out In The Crowded Biopharmaceutical Contract Manufacturing Market

    Differentiating one’s CDMO offering from competitors is an essential component of gaining awareness, familiarity, and being awarded business. When CDMOs understand what motivates drug innovators to outsource, who is involved in the service provider selection decision, and which CDMO attributes have the greatest influence on CDMO selection they are able to communicate what is unique about their offering to the right audience at the right time. 

  • Using Positive Controls In Container Closure Integrity Studies
    Using Positive Controls In Container Closure Integrity Studies

    This webinar describes the use of positive controls as an important element of CCI studies designed to validate packaging components for CCI or to qualify processes for producing good CCI.

  • Oxygen Permeation In Pre-Filled Syringes
    Oxygen Permeation In Pre-Filled Syringes

    This webinar presents how to design and conduct studies to assess the total oxygen permeation rate of your pre-filled syringes, and how to determine if the permeation is primarily through the plunger or through the tip.  Protecting oxygen-sensitive formulations during filling will also be discussed. 

  • Non-destructive Moisture Analysis Of Freeze Dried Product
    Non-destructive Moisture Analysis Of Freeze Dried Product

    This webinar describes how non-destructive headspace moisture analysis can be used for characterizing batch moisture distributions, for lyo cycle development and optimization, and for freeze dryer moisture mapping and validation.

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NEWS

REGULATORY COMPLIANCE VIDEOS

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