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Research & Development
Quality is critical for the safety and efficacy of all pharmaceutical products; we work under Good Manufacturing Practices (GMP) conditions and consider quality from the early stages of drug design right through to delivery of finished products.
ANWITA quality-assurance system provides the framework for delivering consistently high-quality Pharmaceutical products, Neutraceutical and dietary supplements, it’s the mind-set of our team that truly distinguishes the quality of ANWITA’s products and services. This enables us to make better products more efficiently, and cost effective. Anwita been developing and manufacturing high-quality drugs and supplements with experiences technocrats having more than 25 years.
brings quality to the fore from the very beginning of the product development and manufacturing process, improving efficiency as a result. Combined with Process Analytical Technology (PAT), QbD means stepping away from traditional quality testing methods. Instead, QbD employs systematic, data-driven strategies to deliver quality outcomes, minimize risk and avoid unnecessary downstream issues.
Maintaining quality has always been vital for the healthcare industry to protect the safety of patients and consumers. Quality by Design (QbD) brings quality to the fore from the very beginning of the product development and manufacturing process, improving efficiency as a result. After all, testing products at the end of the manufacturing process limits your options for correction. Quality cannot be tested into a product, it needs to be infused into it, by design.
Combined with Process Analytical Technology (PAT), QbD enables forward-looking companies to move away from traditional quality approaches and instead employ systematic, data-driven strategies to deliver quality outcomes.
QbD and PAT approaches are actively encouraged and expected by key regulatory authorities including the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), as well as through guidelines published by the International Council for Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
QbD offers a better understanding of the manufacturing process, making scale-up from laboratory to mass production significantly easier. While QbD/PAT introduces additional steps to the initial stages of the product development process, this investment (in terms of time, money and resources) protects against variability later on – minimizing risk, reducing waste and saving time in the long run.
QbD can also simplify regulatory compliance processes. By creating a formulation and process design space that ensures compliance, later adjustments within this design space (such as during scale-up or in the event of variation in raw material characteristics) do not need to be registered with regulatory bodies, preventing significant delays when bringing a product to market.
QbD approaches based on PAT also facilitate real-time release testing. This gives companies earlier information on product quality and means that any manufacturing problem can be dealt with faster, in a more informed manner.
QbD also puts the quality assurance framework necessary for continuous process verification (CPV) in place. CPV is an alternative approach to process validation in which manufacturing process performance is continuously monitored and evaluated. Since CPV is done in real-time, negative trends during manufacturing can be rapidly counteracted with suitable measures. Thereby, product quality is maintained and batches do not need to be destroyed.
Assurance for patients and consumers that their medicines and supplements are of an enhanced level of quality, meaning they are consistently safe and effective A more reliable supply, preventing out-of-stock situations, or the need to destroy batches due to poor
At Anwita we give very importance to the quality and all of our formulations were with high quality standard.