Quite a bit has been written about data integrity in recent years, and an embedded, effective quality culture remains a critical success factor for fully realizing strong data integrity. In recently published guidance on data integrity, the FDA goes so far as to state very directly that “it is the role of management with executive responsibility to create a quality culture where employees understand that data integrity is an organizational core value and employees are encouraged to identify and promptly report data integrity issues.”
A validation master plan (VMP) outlines the principles involved in the qualification of a facility, defining the areas and systems to be validated, and provides a written program for achieving and maintaining a qualified facility. Master plans are written to assist an organization with validation strategies or to provide control over a specific process.
This article presents a detailed summary of the drug GMP warning letters issued in FY2018, as well as a comparison of trends since fiscal year 2013. A comprehensive GMP intelligence program includes evaluation of health authority enforcement actions, including FDA Forms 483, warning letters, seizures, recalls, and consent decree agreements. This allows manufacturers and sponsors to identify new trends in the focus of FDA inspectors and to act to address or justify similar situations at their own firms.
3D printing allows drug companies to not only boost efficacy and adherence but also contribute to their brand longevity by expanding and capturing market share with other dosage form options.
Aseptic blow-fill-seal systems for packaging pharmaceutical liquids incorporate materials and process that provide critical advantages for sustainable initiatives.
Everyone is fixated on streamlining production processes and reducing the bottom line. This means getting new instruments into the workflow as soon as possible.
While there are some that choose to install a facility monitoring system just because regulatory guidance states one should be installed and used, many, given the choice, would choose not to.
Avoid production quality-related issues by understanding and knowing how to identify the most common causes of punch tip edge wear.
This paper focuses on how to enhance a pharmaceutical production facility's process safety with a dynamic checkweighing system.
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.
The HygroClip2 ADVANCED humidity and temperature probes offer you maximum repeatability and an accuracy of ±0.8 %RH and ±0.1 K.
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.
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.
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.
Advanced Powder Transfer for Media and Buffer preparation and Solids additions.
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.
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.
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.
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.
This webinar will review how oxygen levels in finished parenteral drug containers can be determined and controlled throughout the product life cycle by using laser-based headspace analysis.
Pilgrim Software, Inc., a leading provider of cloud and on-premise enterprise quality management solutions, recently announced it is formally changing its name to Pilgrim Quality Solutions and will begin operating under the new trade name effective immediately.
Tapemark is pleased to announce the addition of several new capabilities for transdermal patches, including the formulation, blending, and coating steps in the patch manufacturing process.
EMC Corporation recently announced that Sanofi Pasteur, a world leading vaccine manufacturer producing more than 1 billion doses of vaccine per year, has deployed EMC® Documentum® D2, enabling the company to accelerate time-to-value through the power of configuration.
The U.S. Food and Drug Administration today issued a Warning Letter to The Avalon Effect Inc., a company based in Franklin, Tenn., for its marketing of a light therapy product that claims to cure or treat symptoms of fungal meningitis, methicillin-resistant Staphylococcus aureus (MRSA), concussions, Lyme disease, and other diseases.
Flamel Technologies SA (NASDAQ: FLML) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's New Drug Application (NDA) for an undisclosed hospital-based product.
Coding for Compliance Domino prepares you for ePedigree.
PCI is a market leader in the provision of Cold Chain management services and has extensive capacity and unrivaled expertise to accommodate our client’s refrigerated and frozen storage and distribution requirements.Our extensive Cold Chain storage areas are all fully validated, continuously monitored and alarmed, and offer different storage temperatures, from Controlled Ambient (15-25°C) right down to -196°C.
Today’s Life Sciences industry is facing major challenges like patent expirations and low R&D productivity, increasing competition globally and decreasing margins, as well as non-optimized processes and compliance pressure.
Managing and leveraging biologics data, especially in development, is challenging as experimentation generates a large amount and wide variety of complex data while scientists must track genealogies within this complex stream of data to arrive at an end entity.
