Ensuring Product Quality Assurance with a LIMS Solution

It is crucial to have a tight formulations control process in any laboratory environment. A robust formulations management plan can help to meet specifications, ensure product quality, and decrease manufacturing costs to ensure profitability. The formulation requirement becomes more stringent the more regulated the industry segment is.

Strict guidelines are created to ensure product quality, safety, and effectiveness. This article will address the challenges associated with product formulation processes and outline how a Laboratory Information Management System (LIMS) can address those challenges.

Product Formulation Challenges

Homemade formulations do not allow for consistency across batches, they lack adequate controls, checks and balances. If you were constructing a simple formulation for a smoothie using fruits, yogurt, sweetening agents, and ice, you could have a good idea about the amounts required to create the smoothie.

Products that are made on different days of the week could have some differences, but may still taste extremely similar. The difference in quality and consistency between homemade batches is because of the inability to utilize specific production conditions (temperature, time etc.), clearly documented processing steps, extremely accurate measuring instruments, and quality checks.

For the vast majority of the formulations utilized for production in the industry, this is not the case. In these cases, the degree of control employed in formulations for product manufacturing is of great significance and directly affects product quality, consistency, reliability, and safety.

Formulations generally do not entail chemical reactions or synthesis; they are done by measuring solids by weight and liquids by volume. Even though there are no chemical reactions needed, there are numerous aspects of chemistry present in a formulation, i.e. the thermodynamics of mixing, surface chemistry, colloids, phase equilibria, solutions, emulsions and suspensions.

Even more vital is how these principles are connected to weather resistance, texture, adhesion, shelf life, allergenic response, biodegradability, and several other properties. Formulations development is frequently performed using fairly rudimentary trial and error techniques. While that can work for one-off formulation development, a robust system must exist for routine large-scale development operations.

Critical in Regulated Industries

It is crucial to have good control of the formulation process in heavily regulated industries such as Biopharmaceutical. It is vital to properly document the development, testing, approval and lifecycle management of formulations.

Only products with formulations that adhere to regulatory approvals are distributed. Routine commercial product manufacturing is then based on this specific amount of ingredients, conditions, processing steps, controls and quality specifications.

For example, the rate of bioavailability and dissolution of a solid dosage drug product can significantly differ, based on its processing parameters and formulation considerations. Imagine a platform where comparing slight differences within many formulations will permit a scientist to compare the results in the same place and establish the next steps.

It is crucial that a final product has a high degree of uniformity, and lack variance between batches, which enhances the quality overall. That is only achievable with the considerable expertise and effort of the formulating scientist. Painstaking documentation of formulations development and testing may be required.

It is also vital to consider the many variables that can influence composition, stability, physicochemical properties, and utility of the products for appropriate manufacturing based on well-defined processes. So that it is marketable against the competition, it is also crucial to consider the cost component.

Records Retention is Essential

Keeping detailed documentation on development research and the capacity to look through historical records is crucial to the formulation process. Mining and reuse of legacy information is vital in the process of knowledge management and can save tremendous amounts of money and time.

It is essential to possess a robust documentation and information management platform when formulating a new product. When lab-scale experiments are carried out, correct documentation and the capability to produce intelligence from them will avoid wasting resources and time.

It makes the most sense to carefully consider the ingredient and processing costs from the start in the case of low margin industry/products. This can stop mistakes by having a choice to check historical records of trial formulations, their output, product results and cost.

Without a universal technique for documentation, storage and retrieval, collating and searching for any useful information becomes hugely challenging. Information could be kept on shared hard drives or individual computers. In the worst case, the information may not be located. Only a robust electronic system, which provides total historical search capabilities based on user-defined parameters, can really be beneficial to an organization.

This kind of formulations management platform will provide a comprehensive set of capabilities for developing and managing formulations, and eliminate the requirement for scientists to document anything outside of the system.

LIMS to the Rescue

A lot of the problems in managing the process of the formation can be addressed by implementing a LIMS solution with robust formulations management capabilities. It will make life easier for managers and scientists to correctly manage all product formulation requirements from the beginning through to the finalization of a formulation.

Having the proper tools in place can make a massive difference in your product quality, and ultimately, your profitability. Some primary formulation capabilities to consider in your LIMS system include:

  • Formulation templates which are reusable to save time and effort
  • The capability to move formulations between stages with clear management approval
  • Total historical data search and indexing capabilities
  • Robust capabilities for sample and specifications management, and product testing/analysis throughout different stages of formulation
  • User-friendly interface which permits alteration of ingredient quantities within a formulation and the ability to see the effect of those alterations on the cost or physical properties
  • Accommodation for differing sample calculation needs

Summary

Perfecting your formulations process means enhanced product quality, quicker time to market, and decreased cost, providing you with a competitive advantage. Unfortunately, when deciding upon a formulations strategy, the idea to purchase a LIMS solution with robust formulations management capabilities is sometimes overlooked.

LIMS is sometimes considered a complex “Information Technology” solution, employed by scientists for sample management and product testing. A LIMS solution is vital for any type of laboratory environment which requires management and documentation of complex scientific information for product development and sample testing, contrary to that misconception.

A modern, robust, highly configurable LIMS solution with integrated formulations management capability will play a key part in managing the process for establishing the right formulation.

This information has been sourced, reviewed and adapted from materials provided by LabVantage Solutions, Inc.

For more information on this source, please visit LabVantage Solutions, Inc.

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