TOP CHALLENGES THAT CAN BE OVERCOME USING BATCHMASTER NUTRACEUTICAL SOLUTIONS
BatchMaster Software solutions give nutraceutical manufacturers better control over their inventory and processes to overcome these common industry related challenges:
1. Formulation:
As the scientific understanding of nutrition evolves, nutraceutical manufacturers are continuously developing new products to meet changing demands. This requires ongoing research and development efforts to formulate new supplements that are effective and safe.
- Physical Property and Cost Analysis tools enable multiple formulators to quickly develop and analyze formulations to meet label claims, then gain management approvals.
2. Intellectual Property Protection:
Many nutraceutical manufacturers want to protect their intellectual property, including proprietary formulations or manufacturing processes, from competitors who may seek to replicate their products.
- Formulators, production staff and other users are assigned strict security levels that limit their ability to view, add and modify specifications. For even greater IP protection, alias names can be used in place of actual Item Identifiers and descriptions in the user screens.
3. Standardization:
Many supplements, especially herbal supplements, are made from natural ingredients, can vary in composition from batch to batch which makes it challenging to ensure that batch jobs use the proper amount of active ingredients.
- Batch production processes consider the expiration date rotation methods, quality statuses and variable characteristics, such as potencies, of lot-controlled inventories when allocating raw materials to a batch job.
4. Quality Management:
Nutraceutical manufacturers must follow strict quality control procedures to ensure that each batch of supplements are consistent in terms of ingredients and dosage.
- QC tests, SOP’s, inspection plans, checklists, nonconformance, CAPA, as well as document control, training management, and audit management are all supported by BatchMaster solutions.
5. Regulatory Compliance:
Nutraceutical manufacturers must comply with supplement regulations, labeling requirements, safety standards, and other regulations to ensure the safety and efficacy of their products.
- BatchMaster solutions offers revision controls and audit trails, electronic signature (CFR 21 11), and electronic batch records (EBR).
6. GMP Validation:
A growing number of nutraceutical manufacturers must achieve and maintain their GMP Validation status.
- BatchMaster validation templates can help accelerate one’s validation process, especially when the validation is being performed by the 3rd party validation agency in parallel with the software implementation of the BatchMaster application by BatchMaster’s own consulting team.
