Procedural Stages in Pharmaceutical Manufacturing- TatvaChintan
“INCREMENTAL ADVANCES CAN ADD UP TO TRANSFORMATIVE CHANGES”
If you want a roller coaster ride full of ups, downs, twists, and turns, move a portion of your portfolio to the pharmaceutical or biotech sector. Every day, including weekends, news wires are full of press releases from these companies outlining the results of clinical trials conducted on new and experimental drugs and compounds.
Drug development and processing is a lengthy process, sometimes taking up to 15 years to get the final outcome. Whether biologic or small molecules, all medicines have to meet strict regulatory and quality standards to ensure patient safety and product integrity. Depending upon the manufacturers there are different ranges of quality of the raw materials used. The pharmaceutical manufacturing industry has produced a variety of medicinal and other health-related products. These products have saved millions of lives. As drug manufacturers are increasingly looking to reduce the costs, they might choose a lower-quality version of the regulated raw material.
Why grade matters? Degraded materials introduce the risk for introducing contaminated particles which could impact the final product. It might also affect the manufacturing process, altering the chemical reaction. As the quantity of these materials increases, the risk it posesses also increase. Balancing cost and risk at the early stage of development is a big challenge for all the manufacturers. The high quality products will be expensive, but will be of lower risks as it passes all the clinical tests and certified. Biopharmaceutical manufacturers have become increasingly reliant on their suppliers to assist with product compliance. The real consideration is looking at the end product, learning actual details and staying in line with the requirements.
The simplest solution is to work with a supplier who is capable of providing raw materials of different grades. The supplier must have a clear understanding the quality terms and to note whether the raw materials are non-regulated, non-GMP quality or highly regulated materials. The most important thing a supplier can provide is insight about what the regulatory requirements are demanded by the agencies in each region where the manufacturers sells their products. Choose an active supplier of pharmaceutical raw materials like Yashica Pharmaceuticals, TatvaChintan Pharma Chem, Kirsch Pharma, Zhejiang Medicines & Health Products Imports & Exports Co., Ltd etc. who will provide you with the certified and well tested materials.
Any changes in their supply or products should be passed on to the customer. The customer cannot expect the raw material supplier to understand all their needs for a particular material. But neither should the supplier assume that the testing they provide is sufficient for all customers. Biopharma companies have relied on an ever-increasing range of suppliers for raw materials and disposable processing components.
Identifying the critical quality attributes of a raw material requires an understanding of the relationship of the raw material and its impact on the quality of the drug being produced. A secured supply chain is equally important. No matter how good a supplier is if a problem arises, this can cause disaster for the manufacturers who rely on them. Process control is an other factor, a qualified raw material supplier will have up-to -date facilities and control technology.
Balancing Cost vs Risk It is obvious that biopharmaceutical manufacturers have a great amount of choices to make when investing time and money into the development of new product. When looking at what raw materials to source and of which grade, it can be a hard to get the answer. Involving good quality raw materials from the start may remove the risk factor the manufacturer may face.
Recent advances in science have propelled biopharmaceuticals into a new realm of manufacturing complexity. Companies are implementing advanced manufacturing techniques to keep pace with advances in science and medicine. Using raw materials of good quality not only ensure patient safety, but also increases the trust between the pharma industry and the supplier.
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