Following The Path To Compliance
Mon, 02/09/2009 - 9:07am
The Ins and Outs of cGMP Audit Preparation
Drug companies lose upwards of $600,000 - $1M of revenue for every day their drug is not available in the market. Typically these figures are drawn to represent the need for speedy clinical development; however, in this article we will talk about the enormous financial detriment of having a drug pulled from the market – even temporarily – by a regulatory agency due to a host of possible reasons.
As a consumer, if you learned that a drug was suddenly taken off the shelves by the Food and Drug Administration (FDA) due to inconsistent quality control processes, for example, would you be clamoring for the product's eventual return? Probably not. You'd likely look to alternative treatments if they were available and would have a negative sentiment in your mind about the drug manufacturer as well as its drug.
The point here is that the $800M+ it costs to bring a drug to market is only half the battle for drug manufacturers. The balance of the equation is the ability to effectively and compliantly manufacture that product with unwavering consistency to ensure patient safety, mitigate risk and maintain regulatory compliance.
This article will explore the severe consequences a drug company can face if they deviate from current Good Manufacturing Practices. It will also discuss some of the solutions available to help these organizations streamline their quality assurance programs companywide. Moreover, with the right centralized systems in place, drug firms can better adhere to regulations, enhance operational performance, improve product quality and even derive critical intelligence from across the organization. In turn, the organization will avoid costly missteps in the manufacturing process and stave off avoidable violations and liabilities.
Drug manufacturing quality is of utmost importance when the FDA or some other regulatory body comes to conduct an impromptu or scheduled audit of a drug firm's manufacturing operation. The purpose of these audits is to ensure current Good Manufacturing Practices are followed by the pharmaceutical and biotech firms to ensure that the products produced meet specific requirements for identity, strength, quality, and purity." (FDA guidance 21 CFR 211)
sing the $600,000/day figure cited above for daily lost revenue of a pharmaceutical or biologic drug, this would equate to $18M for every month a manufacturer's drug was not on the market. These numbers are simply too staggering for any drug manufacturer to bear, especially given the tight patent exclusivity timelines and heightened competition from generic drugs. By implementing the right centralized systems, procedures and technologies, firms can protect themselves from such product recalls and related liabilities.
Audit Preparation and Management
There are a number of issues today with how most pharmaceutical and biotechnology firms prepare for and manage internal and external audits. First and foremost, there is almost always a lack of data centralization to provide a companywide view of quality, risk and compliance. These large companies typically have multiple auditing groups and disparate systems spread across many geographic regions. This can make it quite difficult and inefficient to find and report on important information, track and trend observations and CAPA for improvement purposes and to keep tight reigns on processes that impact safety, quality and compliance.
Many drug companies today rely on Excel spreadsheets and inadequate home-grown applications to manage their product manufacturing processes. This is alarming when you consider that these are the same bellwethers whose products likely fill your home medicine cabinet. The fact of the matter is that neither ad hoc "solution" comes anywhere close to providing the necessary level of functionality and centrality to ensure cohesive global compliance and consistent quality manufacturing.
Fortunately there are comprehensive tools available on the market that can help these firms successfully navigate the turbulent waters surrounding quality drug manufacturing.
Comprehensive Audit Management Software
Tightly integrated audit management software solutions can be installed at the company level to centralize all quality, risk and compliance data across the firm. An integrated closed loop tracking system, a powerful workflow engine, intelligent process automation and internal control mechanisms harmonize quality assurance practices, standardize reporting, improve audit planning, identify root causes of inconsistencies, uncover insightful trends and afford a host of other benefits.
In turn, this helps the firm increase performance across the organization. Specifically, manufacturers can expect the following types of value:
* Improved quality and enhanced compliance across the manufacturing lifecycle by ensuring commitments are met, observations and CAPAs are closed and all communication channels are open to share critical information
* Reduced liability by facilitating visibility into significant business risks before they become problematic
* Improved operational performance by streamlining and integrating all reporting and tracking, and automating the entire audit lifecycle
* Increased revenues and decreased expenses by improving efficiency of auditing programs worldwide, eliminating redundant efforts, removing duplicate audit systems and driving easier and faster response times to auditors
These enterprise software systems can integrate with other legacy systems within the organization to drive process standardization, data normalization and streamlined quality manufacturing operations.
As the drug industry continues to consolidate, development costs continue to skyrocket, patient risks continue to gain widespread attention, and standards become even stricter, manufacturers need to find ways to increase performance and mitigate risk. That is, they need to get their products to market even faster (and keep them there), while continuing to improve quality, increase patient safety, and contain manufacturing operational costs. This is definitely a very tall order. However, with the right tools and systems in place, these challenges can be met and overcome.
A company's ability to effectively anticipate, prepare for and successfully pass regulatory audits is paramount to its ongoing success in the tumultuous drug development and manufacturing industry. With drugs already being pulled off the shelves at a record pace due to poor manufacturing quality, pharmaceutical and biotech firms need the right audit management/quality assurance program in place.
This becomes even more critical when you consider the eventual emergence of personalized medicine. The advent of individualized care and its foretold dramatic impact on drug manufacturing as we know it, will raise the stakes of successful drug development to a level never seen before. When this happens, drug firms that haven't prepared themselves adequately will find themselves in deep trouble.