Press Release (ePRNews.com) - TORONTO - Sep 05, 2018 - Join industry expert Phil Johnson, Senior Principal of Quality and Compliance Services at IQVIA for a live webinar on Wednesday, September 19, 2018, at 10 a.m. EDT (3 p.m. BST/UK).
The pharmaceutical and biopharma arena encompasses a variety of drug types, often classified into two broad categories of sterile and non-sterile drugs. Drug products are further grouped based on dosage types, e.g., oral solid dosage, topical, injectable, and combination. Regulatory requirements enforced by the FDA and international drug regulatory agencies obviously apply to the finished drug product. In addition, those regulatory requirements apply to active pharmaceutical ingredients (APIs), various excipients, and other raw materials that are utilized in formulating and manufacturing the finished dosage drug product. Many drug companies rely on contract manufacturers to produce their drug products. In addition, firms that are directly manufacturing their own drug products and those that rely on contract manufacturers will typically rely on external service providers for such ancillary activities as sterilization services, chemistry analytical services, microbiological testing services, and others. It is critical that the manufacturers of drug products (including APIs) are aware of and abide by the applicable regulations, including requirements and expectations associated with the supplier quality management aspect for suppliers of drug materials, supplies, and key manufacturing critical services.
A significant part of the regulators’ focus in enforcing the drug regulations is to scrutinize the robustness and effectiveness of the drug manufacturers’ supplier qualification processes. Regulatory agency interpretations of the applicable drug regulations and various associated guidelines promulgated by those agencies have historically provided a well-defined framework for what is expected to be done to ensure adequate control over materials, supplies, and services. The need to proactively verify a supplier’s ability to consistently provide materials, supplies, and services that meet specifications and user requirements is the cornerstone of a supplier quality management program. These activities are often considered a part of purchasing controls. In addition, a well-designed program for receiving and evaluating shipments of materials and supplies is mandated. The supplier quality management program must also provide for monitoring the quality aspects of materials, supplies, and services over time, and ensure that appropriate measures are taken when they are found to be out of specification or unacceptable in some quality-critical aspect.
The supplier quality management program has clear and important linkages to the overall corrective and preventive action (CAPA) aspect of a manufacturer’s quality system. Gaps in the CAPA program can arguably be identified as one of the most common contributors to enforcement actions taken by the FDA and international regulatory bodies charged with ensuring compliance of drug manufacturers with quality system requirements.
This presentation will include an overview of 21 CFR Part 211, as well as various FDA drug guidelines, providing direction and industry views on how the FDA interprets purchasing controls for drug manufacturers and their suppliers. Additionally, this webinar will provide a general overview of international regulations and their correlation to FDA requirements as they relate to drug manufacturing quality systems. Our featured speaker will also offer analysis of the most common FDA enforcement actions (483 Observations, Warning Letters) and present the latest FDA statistics for 2018 year-to-date on the increasing number of product recalls for drug products.
For more information or to register for this event, visit Quality In, Quality Out: Regulations Driving Pharmaceutical Supplier Quality Management (Part 3 of 4).
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