Why validation matters: A Brief Guide to a Critical Aspect of the Pharmaceutical Manufacturing Lifecycle
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Validation is a critical process in the pharmaceutical manufacturing lifecycle to ensure quality and safety. It involves proving all aspects of manufacturing and distribution that impact quality, from facilities and equipment to software and risk management. The FDA provides recommendations for validation at all stages and inspects manufacturers' processes. Validation demonstrates processes are capable of consistently producing quality products. It is a legal requirement and important for reducing recalls, lawsuits, and investigations. Thorough documentation is needed to show validation was properly carried out across the entire product lifecycle.
Why validation matters: A Brief Guide to a Critical Aspect of the Pharmaceutical Manufacturing Lifecycle
- 1. Why Validation Matters: A Brief Guide to a Critical Aspect of the Pharmaceutical Manufacturing Lifecycle June 3, 2013 Barry Peters and Heather D. Ferrence | Telerx According to the World Health Organization (WHO), the process of qualification and validation is applicable to any aspect of operation that may affect the quality of the product either directly or indirectly. The primary goal of the validation process in the pharmaceutical industry is to have documented proof that quality is part of each and every step of the manufacturing and distribution system, instead of merely testing products at the end of the process. The Food and Drug Administration (FDA) has set recommendations for all stages of the manufacturing process lifecycle, whether related to plant equipment, software or risk management. Furthermore, the FDA has the authority and responsibility to inspect and evaluate the validation process performed by manufacturers. Whether it is due to government regulation, cost effectiveness or quality assurance, the pharmaceutical industry cannot ignore the necessity of a proper validation process. Defining Validation (in the Pharmaceutical Manufacturing Process) The term validation in the context of pharmaceutical manufacturing can easily be misinterpreted and because of that, companies must define specifically what it means for them and detail how exactly they will implement it in order to achieve the desired results. A defined validation methodology is critical in determining the scope of validation required. The Validation Plan should detail the risk based approach taken to balance business requirements, operational and procedural controls while meeting regulatory requirements. It is important to have proven techniques to find cost efficiencies associated with implementing, using, and maintaining computer systems in regulated environments. Often, companies tend to either overdo or underdo it. Lack of knowledge about how and what to validate can translate into too much documentation because of uncertainty as to where to draw the line or not enough information because the validation task seems so daunting. One overkill
- 2. example includes; from a testing standpoint, if an area chooses to report information over and above what is included in the requirements, their system providers, whether in-house or third party, need to be aware to adjust their testing systems accordingly. Otherwise, that incompleteness could be misconstrued as a deficiency. An example of underdoing includes the lack of traceability from the requirements through the executed test protocols. Additionally, many companies mistakenly believe that the term “validation” is solely IT-centric, when in fact the concept of validation involves a number of aspects beyond computer system validation, including, but not limited to: the input, the outputs, the users, equipment, facilities, , cleaning, process, and analytical method. In sum, and as defined by the FDA, process validation is the collection and evaluation of data, from the process design stage through the end of the product lifecycle. This ongoing compilation of data provides the basis for established scientific evidence which concludes that a process is capable of consistently delivering quality product. The Importance of Validation The Federal Food, Drug and Cosmetics Act Section 501 (a)(2)(B) which states that “a drug is deemed to be adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or were not operated or administered in conformity with Current Good Manufacturing Practices (CGMPs),” serves as the legal basis for the practice of validation. In today’s world of recalls and lawsuits, it is imperative that pharmaceutical manufacturers develop a Validation Master Plan and thoroughly document how the validation process is carried out. As more pharmaceutical companies find themselves outsourcing a variety of customer-facing services to third-party vendors, the role of a contact center is an important one during the life of a product, as interactions with consumers and medical professionals become crucial for traceability. In an environment where consumer safety and privacy are front and center, a carefully documented system and process leaves no room for questions during an audit, internal or external investigation or government-mandated recalls. Companies that are a part of product complaint and adverse event processing or companies that need to meet the requirements of core areas of global data protection and privacy standards must have well thought out validation processes and detailed documentation. The chain of events resulting from consumer complaints, whether using a third-party contact center or performing consumer engagement duties in-house, illustrates why validation is critical. For example, call takers must document each consumer complaint in great detail, such as product information, lot number, personal patient information and other medication the patient was taking at the time of the product problem. Each file is then routed to the quality unit within the manufacturer to run additional reports on that particular lot to determine how many other similar reports exist. Depending on the reports, companies can take a variety of next testing steps to determine the cause of the defect and how widespread it may be. Depending on the outcome
- 3. of the testing, or whether the FDA determines that they must conduct a general investigation on a particular product, all the necessary documentation must be up to date, available and traceable from the requirements to the finished product. The Bottom Line As companies work to reduce product failures, rejects and reworks, they must avoid some of the most common challenges of a validation process such as: lack of time, lack of personnel, lack of experience and knowledge and poorly designed documents. By implementing a successful validation process, pharmaceutical manufacturers can improve productivity, reduce recalls and consumer complaints and also reduce the burdensome process of investigations.