Formula Flexibility: 3 Things You Need to Know

On October 12, 2021

For pharmaceutical and biotech companies, the research and development (R&D) phase is essential for innovation and improvement. This phase is responsible for the discovery, design, manufacture, and testing of pharmaceuticals. As such, this phase involves many experiments and tests, and formula flexibility is key to the process.

1. What is formula flexibility?

Formula flexibility is the ability to modify a formula in any way when it is needed. It plays an important role in the clinical development phase where researchers can make changes according to what they learn from their experiments, tests, or trials.

The need of formula flexibility for R&D purposes is usually higher in companies that dedicate themselves to pharmaceuticals and medical food products because these industries face challenging experimental research. The capability to try different scenarios is required to achieve successful results in terms of safety, efficacy, quality, and various other factors.

This feature is also applicable to clinical and commercial manufacturing, where the use of consumables such as pipettes, syringes, and gloves is ordinary. In most cases, this type of item could not be part of the approved formula, the estimated quantity could not correspond to the actual consumed quantity, or there could be some alternative items that can be consumed such as different pipettes from different suppliers.

2. What are the requirements for formula flexibility?

The company needs equipment that allows real-time updates of formulas without interrupting the production process and slowing down the schedule. AX for Pharma 365™ provides this flexibility by allowing in-process updates on formulas as well as the capability to define a simple approved formula as a starting point. Additionally, AX for Pharma 365™ enables clients to add or remove ingredients in order to adjust the achieved results.

Key factors to be considered when conducting clinical trials are regulatory compliance and patient safety. Even if the trials are for research purposes only, it is necessary to track all consumed material as part of the regulatory compliance process. This task can be done automatically by a robust ERP system for pharmaceuticals like AX for Pharma 365™, which provides an automated and flexible data storage and management system that is very useful during clinical trial phases.

During R&D and production, AX for Pharma 365™ tracks the consumption of every single item in terms of:

  1. Item number and name
  2. Batch and sub batch number
  3. Quantity
  4. Expiration date
  5. Batch disposition code
  6. Use codes

AX for Pharma 365™ provides a user-friendly interface via handheld devices that simplifies everyday work. With just a few scans and inputs via touch screen, it is possible to record all the information needed and update it in the ERP system.

Once the production phase ends, all the formula changes can be reviewed by the quality department for approval, and then the final formula version can be defined.

3. What are the benefits of formula flexibility?

AX for Pharma 365™ formula flexibility allows pharmaceutical companies to not only conduct R&D more efficiently, but also make their clinical trials compliant with current regulatory standards while saving time and money along the way. Formula flexibility is extremely important in R&D for pharmaceutical and biotech companies as well as in clinical trials due to the benefits it provides throughout all phases of development.

Additionally, it allows companies to develop drugs quickly and efficiently. Formula flexibility in R&D for clinical trials can be used to improve the chances of successful R&D results within a shorter period. Contact us today to learn more.