Formulations & Development
Quality assurance is a major challenge, particularly in light of growing regulatory stringency and the international dimensions of trade, rightly so, since manufacturing of substandard medicines result in prolonged treatment for patients, drug resistance and increased incidence of adverse effects.
We at Plethico follow the self-imposed stringent quality standards to ensure that all the products being manufactured are consistently safe, effective and of good quality.
While the general principles of GMP apply for all types of pharmaceutical products, herbal products differ from conventional pharmaceutical products in that they are prepared from herbal substances, which include materials derived from leaves, seeds, bark, essential oils and resins.
Because of their unique origin, herbal products often require procedures for their processing; manufacturing and storage that differ from those used for conventional pharmaceuticals, and therefore present a degree of complexity.
In Plethico, we take pride in stringent following of specially developed protocols for hygiene, sanitation and processing that are specific to herbal products. Some of these are:
- Storage facilities with quarantining of incoming herbal matter to prevent the spread of microorganisms,
- Maintenance of segregated areas for different herbal materials and of appropriate environmental conditions.
- Production areas controlled for dust, fumes and vapors generated by the processing of these substances,
- Cleanliness of equipment to avoid microbiological contamination as per US FDA GMP norms.
At Plethico, we ensure that each major stage of the manufacturing process is validated to ascertain that the finished products comply with all quality and design protocols, and consistently meet their specifications.
In other words, we ensure that quality; safety and efficacy are designed and built into our products.