Creating a Proactive Approach to Pharma CAPA via GMPs and Enterprise Quality Management Solutions (EQMS)

Mention CAPA in different companies, and you are likely to get slightly different definitions of the process. In the life sciences industry, CAPA pertains more to a formal event management and remediation system for systemic events, as opposed to minor events that occur and are corrected as they happen. CAPA as a term, started as an ISO standard for corrective actions and preventive actions. FDA’s Good Manufacturing Practices (GMP) regulations were adopted in the 1970s and have not been formally changed since that time GMPs defined quality processes and at the time of adoption were conducted manually and kept in paper-based lab notebooks.

As computers and PCs were introduced into the marketplace, manufacturing companies embraced the efficiencies of this technology revolution.  Eventually computers were used for quality processes, as well. The focus on quality became more important, and additional requirements to address quality issues were being established, driven by internal company factors as well as external agencies and patient care concerns.  At the request of the industry, the FDA created the Electronic Records Electronic Signatures (ERES) regulation. Title 21 CFR Part 11 (21CFR11 defined how electronic records and approvals would be used to assure GMP regulations would be followed in the computer age.

Additionally, ISO and the International Commission on Harmonization (ICH) have created additional standards that speak to CAPA. Although these are not explicit regulations, FDA has issued guidance documents adopting these standards. The most common FDA-issued inspection observations (483) and warning letters related to quality within the pharmaceutical industry are due to a lack of a CAPA system or a deficiency of CAPA processes.

The Intersection of CAPA and GMPs

Although CAPA requirements aren’t directly mentioned in GMPs, it is essential for pharmaceutical manufacturers to have a CAPA in place. Having a strong CAPA system and a sound Quality Management System (QMS) are interchangeable. These systems do more than just decrease the chances for a manufacturer to receive regulatory observations or enforcement. Within the realm of life sciences, CAPA has morphed into a system for tracking and managing quality events, determining root cause and taking actions to not only remediate a problem, but also preventing a problem from happening again.

GMPs, by their very nature, deal with enforcing quality of procedures and formulas. In the pharmaceutical realm, GMPs help to ensure uniformity and efficacy -- that when specific drugs are formulated, they’re made exactly the same way each time. If there is a deviation in the process, a CAPA system can help a manufacturer investigate whether that batch is safe for the market. If something goes wrong in the process, it stands as an event that requires attention. By having a CAPA process, companies in the life science space can determine whether a product is still safe and effective for its intended use, and whether it can be released to market or needs to be re-manufactured or destroyed.

Pharma CAPA and EQMS: Formula to an Effective, Proactive Approach

Stringent industry regulations and industry best practices require a more proactive approach to creating an effective pharmaceutical CAPA for post market products. An EQMS can assist in this process, helping to ensure the reliability of and access to information at each step of the way.

By making use of an EQMS to integrate CAPA and quality in the overall manufacturing process, production of post market products can be effectively managed. Here are four key elements to creating an effective pharma CAPA and how EQMS can help:

1. Immediacy

An effective CAPA process is one that operates with immediacy. When a quality event happens, it is recorded and investigated immediately. Unfortunately, in many instances of quality events, millions of dollars of raw material and equipment are invested in a process. Despite an event having been reported, the manufacturing process continues to the point of completion and then -- after considerable time, money, and resources have already been invested an investigation of an event begins. Immediacy is important in that it shortens the time for a manufacturer to decide whether to release, remanufacture or destroy a product following reporting of an event. The earlier remediation is determined, the less money it costs, potentially saving a company millions. EQMS allows you greater insight into the process and a more finely-tuned ability to detect where an event has occurred. From there, manufacturers can test that component -- as opposed to testing the finished product at the end of the manufacturing process.

2. Transparency

An EQMS can offer greater visibility in the supply chain and transparency of process. This allows decision-makers and managers to identify trends that might be happening, or failure rates. It increases the chances of determining if there is a common ingredient or process involved in multiple failure rates.  If a product has been manufactured for years without issues, and suddenly, batches of the product are failing, root cause and corrective and preventive actions need to be taken. EQMS helps to increase transparency and communication across different groups. When there is a quality event with pharma products, the signs may have already been there, but without transparency and deeper insight into various tiers of the supply chain, no one knew where and when an event occurred. What may have seemed like a minor incident managed inside a silo may have been part of a string of minor incidents enterprise-wide that contributed to a far more tangled problem.

3. Communication

Many pharma manufacturers have sites all around the world. When a root cause of a problem has been found, this can make it more difficult to effectively communicate such news -- in real time -- to the manufacturer’s worldwide network. A true CAPA process and enterprise-wide solution finds where those conditions exist and aids in correcting them. If bad raw materials are the root cause of a problem, effective communication of the problem can allow individuals and departments throughout the enterprise to question what other products are made with the same raw materials. Time, money, and effort are saved by pinpointing those products, where the material is manufactured, and/or where else does the manufacturer make that product. With an ideal CAPA system in place, corrections can be made across multiple facilities or investigations of the issue can occur and ensure that a problem is not repeated with another product or another batch of the same product.

4. Collaboration

Pharmaceutical manufacturing today no longer takes place within a company’s own four walls.  Almost all of the raw materials used come from a vast network of suppliers from around the world.  In many cases, manufacturing, packaging and distribution is outsourced to contractors, while the company licensed to sell the product is ultimately responsible for its quality and efficacy.  Most companies try to manage quality using legal quality agreements with little or no visibility into the actual quality of the supplier or contract manufacturer.  According to a recent study across all manufacturing industries, 52% of recalls were due to third party supplier or contractor caused issues.  The next generation of EQMS includes collaboration with the entire supply chain, where events, corrective and preventive actions, and changes are recorded, investigated, approved and trended on by everyone that may be involved.  Extending the EQMS and CAPA system throughout the entire supply chain helps assure the safety and effectiveness of the pharmaceutical products used by the patients who need them.

Learn more about the relationship between manufacturers and their supply chain and the role that open communication plays throughout the process. Download our whitepaper, Minding the P’s & Q’s: Managing Quality and the Globalization of the Pharmaceutical Supply Chain.







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