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As discussed in Part 1, industries that are heavily regulated typically have more stringent formulation requirements. Ensuring product effectiveness, quality, and safety will require implementing strict guidelines. Part 2 will discuss Heavily-Regulated Industries and Importance of Record Retention.

Heavily-Regulated Industries

It is crucial in heavily-regulated industries to strongly control the formulation processes. Equally as important is the proper documentation of formulation development, testing, approval, and lifecycle management. Distribution should be limited to products that receive regulatory approvals.

The manufacturing of commercial products can be standardized through specific controls, ingredients, conditions, processing steps, and quality specifications. As an example, a solid dosage drug product’s rate of dissolution and bioavailability may vary greatly as determined by formulation considerations and processing parameters.

A platform capable of detecting miniscule differences in many formulations will allow lab technicians to compare the results then determine the next steps. Finished products should not have an unacceptable variance from batch to batch. They should possess uniformity to such a great degree it ensures high quality. This will only be possible if the formulating team expertly performs their tasks while meticulously documenting formulations development and testing.

Importance of Record Retention

Maintaining highly-detailed documentation regarding development research as well as the capability of searching historical records is crucial for the formulations process. Efficient data management is crucial to every lab because it can conserve time, money, and effort. Thus, a strong documentation and data management platform is essential for new product formulations. Time and resources can be conserved by being able to quickly gather relevant data prior to carrying out large-scale experiments.

When a laboratory lacks a comprehensive method for documentation, data storage, and data retrieval, searching and processing relevant data will be difficult. This is the case when data is stored on individual hard drives and PCs that are shared. In worst-case scenarios, data may not be found. What can benefit an organization is a universal solution based on a strong digital system capable of historical searches utilizing user-defined parameters.

Part 3 will discuss LIMS (Laboratory Information Management System).

Alpha Engineering LIMS Implementation

Alpha has been involved with the implementation of over 50 LIMS systems ranging in size from small, “off-the-shelf” software systems to very large, highly customized, multi-functional systems, including STARLIMS, for both governmental agencies and private enterprises. For affordable client-focused network consulting services and solutions, please call Alpha today at (410) 295-9500.

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