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