Quality In, Quality Out: Regulations Driving Pharmaceutical Supplier Quality Management (Part 3 of 4)

Following on from the second webinar in this 4-part series, “Quality In, Quality Out: Regulatory Drivers of Supplier Quality Management in the Medical Device Industry,” this third presentation will take a specific and deeper dive into the regulatory requirements for supplier management for the pharmaceutical and biopharma industries.

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.

Speaker

Phil Johnson, Senior Principal, Quality and Compliance Services, IQVIA

Phil is an experienced regulatory and quality based professional who has worked in the medical device, in-vitro diagnostic (IVD) and pharmaceutical industries for over twenty-five years. His core expertise is in the quality requirements for medical devices, diagnostics and pharmaceuticals. This has included the writing, implementation and maintenance of quality systems, auditing of external suppliers and manufacturing/distribution sites and due diligence auditing.

Phil has worked on FDA remediation programs in response to warning letters and import bans, providing strategic consulting to companies. He has had several long-term consulting placements within medical device, IVD manufacturing and distribution sites and corporate offices. He supports companies by providing complete business, regulatory and quality support for global market entry requirements, including the setting up of logistics and distribution networks and the license requirements for these operations.

In his industry roles prior to joining IQVIA he was very involved in supplier management, in both the manufacturer role of evaluating and qualifying suppliers, and also in the supplier role providing services and products to pharmaceutical clients. In his consulting role with IQVIA he has run many supplier management projects, providing support from corporate clients to virtual organizations and start-ups. This has covered the whole breadth of services from supplier selection, evaluation, qualification, monitoring and follow up auditing, covering both business and quality functions. This has given him a good oversight of good client processes and equally poor systems that have needed extensive remediation.

Prior to joining IQVIA in 2002, he was the founder and director of a UK central laboratory providing worldwide IVD services to the pharmaceutical industry.

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