Every product is released into the market after a sample testing to ensure that they meets the specifications and is compliant. Especially in highly regulated industries such as pharmaceuticals, this is a very crucial process to ensure the quality of the product and the safety of the customers.
When a sample does not conform to the established specifications as expected, it is called OOS or Out of Specification. As an OOS result suggests quality deviation or errors at the time of testing, catching it early and implementing corrective and preventive measures is essential to protect brand reputation, customer safety, and product performance and compliance.
OOS necessitates the delay in product launch as the cause of the result must be investigated and eliminated to prevent similar results in the future. The entire batch as well as the product line must also be tested to see if it is a one-off error or a recurring error, which causes further delays. This also adds to the manufacturing cost due to the time delay and additional costs in retesting to ensure the accuracy of the results and root cause analysis in case the results are confirmed. Therefore, to keep costs minimum and improve the rate of getting it right the first time, it is important to prevent OOS.
Understanding What Causes Out-of-Specification (OOS)
5 reasons why you may be getting an OOS result include:
- Reason 1 Errors Due to Tools: Analytical errors may be caused by errors in the methods, techniques, or instruments used for testing. Therefore, validating the methods, calibrating the instruments, and preparing the sample properly is crucial. Human errors could also be one reason for deviations and inaccuracies, resulting in OOS findings.
- Reason 2 Sampling Errors: Errors can also result from improper collection, handling, or preparation of samples. Some of the reasons for sampling errors include inadequate sampling techniques, sample quantities being insufficient, contamination of the samples, or sample storage conditions being improper. These can make the test results unreliable and inaccurate.
- Reason 3 Environmental Conditions: Variations in environmental conditions, such as temperature, humidity, or light exposure, can affect the stability and integrity of life science products. These factors may lead to degradation, alteration, or loss of potency, resulting in OOS results.
- Reason 4 Deviations in Manufacturing Process: Deviations from standard operating procedures, equipment malfunctions, operator errors, or inadequate process controls in the manufacturing process are other causes of OOS results.
- Reason 5 Raw Material Non Conformance: In manufacturing, the inputs’ quality affects the final product’s quality. Any deviations in the raw materials used for manufacturing life science products can result in OOS findings. Contamination and substandard raw materials can lead to impurities, nonconformance, and poor final product quality.
5 Ways to Prevent OOS Proactively
Given the cost and time delays that OOS results in, preventing its occurrence can help businesses manifold. Implementing Good Manufacturing Practices (GMP) helps businesses identify potential risks to product quality and implement mitigative measures to prevent deviations.
The 5 key steps to minimizing and eliminating OOS include:
- Records and Document Management: Document and record manufacturing activities to enable error identification and create an audit trail for investigating deviations to identify root causes and initiate appropriate corrective and preventive action. According to the US FDA, records related to GMPs must be maintained in paper or electronic format. They must capture detailed information about all operations, procedures, instructions, raw material controls, deviations, and measures.
- Create and Implement SOPs: Standard Operating Procedures and Quality Policy are the bibles that govern the manufacturing activity in a company. They must clearly delineate the procedures and processes for manufacturing the products, from specifying the formulations to the processes, controls, operating equipment, and packaging. These must be shared with all employees and easily accessible if required. It must also be revised as and when required, based on the regulatory requirements or the company’s evolving needs.
- Audits and Inspections: While policies dictate how a process must be performed, monitoring and tracking to ensure adherence is crucial. This is enabled by internal audits and inspections which ensures compliance at all levels. Any deviations must be recorded, reported, and reviewed for corrective action.
- Asset Maintenance: Be it the manufacturing site the equipment, or the storage of the raw materials, they should be adequately maintained to prevent contamination. Equipment calibration and sanitization are critical to minimize errors and deviations. Clean premises are also essential to minimize contamination.
- Training: Human error is always a possibility, but can be minimized when the personnel are trained and aware of the criticality of proper handling of raw materials, equipment, and testing. Cleanliness, wearing protective clothing, and preparing the equipment for testing are also important activities that they must know of. Further, only trained personnel must be allowed sensitive tasks to minimize errors.
Minimizing OOS is a gradual process and requires continuous improvement—set metrics to measure milestones and review periodically to ensure that the outcomes are expected. Proactively reduce OOS results to reduce time to market and minimize manufacturing costs.
