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FEATURED ARTICLES

  • The Changing Regulatory Landscape: How Drug Sponsors And CMOs Can Navigate It Together
    The Changing Regulatory Landscape: How Drug Sponsors And CMOs Can Navigate It Together

    The changing regulatory environment is shaping a new paradigm between drug sponsors and contract manufacturing organizations (CMOs). One key aspect is demonstrated quite nicely in a case study from February 2012 (read it here), when the FDA issued a warning letter to a contract manufacturing organization. The warning letter stated in part:

    “In your response, you state that you have informed your clients on the importance of validating the methods, but they have chosen not to validate the methods. In addition, you state that you will inform them again in writing. Your response, however, is inadequate because you do not provide your firm's planned corrective actions for this CGMP violation. You are responsible for ensuring that the test methods used by your firm are validated.” (Emphasis added)

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WHITE PAPERS & CASE STUDIES

  • Safeguarding The Global Pharmaceutical Supply Chain

    In today’s highly competitive world of pharmaceutical development, researchers are increasingly turning to locations in Asia, Africa, Latin America, and Eastern Europe to conduct critical studies. The benefits are clear — progressive pharmaceutical legislation, a welcoming business environment, low-cost operations, skilled technical personnel and easy access to large pools of treatment-naïve patients.

  • 3 Tips For Safe, Secure Healthcare Shipping
    3 Tips For Safe, Secure Healthcare Shipping

    All businesses need their shipments to go smoothly — nothing damaged, lost or late, and no last-minute surprises. And this is especially true in the healthcare sector, where a shipping mistake can cost not just dollars, but the health of a patient. By FedEx Custom Critical

  • Raising Expectations Of Excipients

    An excipient’s role has traditionally been viewed as merely a filler or binder contributing to the stability of the end product. The full value that a formulation can bring to a final dosage form; or the real importance of ensuring an excipient’s quality and performance; are often underestimated, overlooked, misunderstood, or disregarded. In reality, the functionality of the excipient can help determine whether or not a drug succeeds or fails. By Fred Monsuur, Julia Poncher W. R. Grace & Co

  • Help Keep Pharmaceuticals Safe: Metal Detection Overview And Guidelines

    Using metal detection as a means of identifying foreign object contamination has been prevalent in the food industry for decades. Although metal detection has also been in use to identify the presence of ferrous, non-ferrous, or stainless-steel contaminants throughout the past 40 years in the pharmaceutical industry, it has not been widespread.

  • Improving Quality Processes For Medical Device Development And Manufacturing

    Organizations that consistently develop and launch new products efficiently in an environment of increasing regulatory scrutiny, successfully manage regulatory risk. By Mike Kuehne, ACSYS, Inc.

  • Clinical Trial Logistics In Africa: Ensuring Quality, Compliance And Control

    Today’s Africa has increasingly become a source of fascination for pharmaceutical researchers drawn to the study and control of both communicable diseases such as malaria, tuberculosis and HIV/AIDS as well as diseases of the developed world like cancer, diabetes, hypertension and chronic respiratory disease. By World Courier

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PRODUCTS & SERVICES

EZ BioPac™: Powder Transfer Process

EZ BioPac™: Powder Transfer Process

Advanced Powder Transfer for Media and Buffer preparation and Solids additions.

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.

Regulatory

Regulatory

JHP Pharmaceuticals has an experienced in-house Regulatory Affairs department capable of assisting you with Clinical Trial Applications, New Drug Submissions, and Supplements.

Adverse Event Reporting, Safety and Compliance Software

Adverse Event Reporting, Safety and Compliance Software

Adverse event (AE) reporting is a key process point for maintaining safety and compliance. Unfortunately, it’s also incredibly labor-intensive. AE source documents arrive in just about any form—mail, fax, email, even voice records from call centers.

LF-S BenchTop Single-Head Leak Testing Machine

LF-S BenchTop Single-Head Leak Testing Machine

The Leak Testing Machine is used for off-line Non-Destructive Container Closure Integrity Testing. It performs the Leak Testing process on one Container at a time by means of a Testing Chamber under Vacuum or Pressure.

Drug Safety Issue Tracking Software

Drug Safety Issue Tracking Software

Monitoring and tracking the efficiency and accuracy of organizations’ drug safety reporting process can help to ensure issues are logged and investigated when they arise, avoiding delays and/or inaccurate reporting which can result in lack of regulatory compliance, monetary fines, and unwanted scrutiny.
Drug Safety Software Adverse Event Reporting

Drug Safety Software Adverse Event Reporting

TrackWise by Sparta Systems’ Adverse Event Reporting solution tracks reported adverse events and manages the processing of all cases from initial triage through reporting and case closure.
Drug Safety Audits Software

Drug Safety Audits Software

Without a means to track and schedule, drug safety audits tend to be performed on an irregular basis, typically resulting in disconnected audits with recommendations that not followed up on.
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