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Third Party Contract Manufacturing (APIs and Excipients)
Special products require special partners. In cooperation with our long-standing and reliable partners, we offer individual customer syntheses and contract manufacturing.
We search for the suitable partner, specially customized to your needs, in our worldwide network of qualified suppliers that has been established for several years. Together with you, we develop all the necessary requirements for the production, for example what quality requirements have to be met. The necessary documentation underlies also various terms. For example, the main decision factor is, in which countries you want to sell and register your final product. In addition, authorities also require a variety of documents. We are in direct contact with our supervisory and registration authorities (such as the Government of Upper Franconia) in order to clarify all regulatory matters. After detailed discussions with you, we will know which of our reliable partners we can contact to assist you in the project planning and all relevant requirements. If there are any questions about your current projects, we will be happy to assist you in a personal meeting or a telephone conference.
Product Sourcing (APIs and Excipients)
Our wide product range covers a large number of customer demands. Nevertheless we like to search for APIs and excipients that are currently not listed in our product portfolio. Product sourcing is an essential aspect at Cfm, where you can rely on our worldwide network of long-standing and qualified suppliers and manufacturers. As one of the fist companies in Bavaria, Cfm Oskar Tropitzsch GmbH received the GDP (Good Distribution Practice) certificate beginning of 2018. This certification clearly underlies the commitment of Cfm to the pharma standards. Therefore we also can provide a variety of specialties. A good and consistent quality is guaranteed. Our strength is the niche market and we are thriving when you have difficulties to find the materials that exactly meet your quality, documentation and quantity requirements. Due to many years of experience, we are aware of the fact that for some APIs a small gram quantity is already sufficient. But it can as well, depending on the intended use of the goods, rise to a ton scale. Here it is often the excipients such as cellulose as a carrier material which are needed in rather higher kilogram to ton scales.
GDP Compliant Logistics
Security and traceability from the beginning to the end of the supply chain is essential while handling pharmaceutical compounds. The transport of pharmaceutical products is subject to stringent safety regulations to ensure that the quality of the drugs and thus patient safety throughout the distribution chain can be guaranteed. The GDP guidelines give shippers and freight forwarders more responsibility, especially in terms of qualification, training and documentation. We as Cfm also take care about the qualification of our forwarders and couriers. An example of this would be proof by data logger to maintain the cold chain during the entire transport route from our qualified manufacturer to you. For this purpose, suitable disposable or reusable data loggers are used, which record the temperature during transport at regular intervals of exactly 10 minutes. You have the possibility once the goods have arrived at your site to read the data via USB and see immediately, whether there was an interruption or irregularity in the cold chain. Our reliable manufacturers of APIs and excipients are required by their qualification to use forwarding agents that are customized to pharmaceutical logistics and regularly audited.
Securing of Supply Chains – 2nd Sources
What to do if logistic difficulties occur while working with your main supplier? Maybe it is caused by new laws in the manufacturer’s country or just a supply shortage in raw material procurement? It is always good to have an alternative. In this case we are on your side and will help you to be protected. We search for a suitable second supplier, which is in no way inferior to your first supplier in terms of quality, documentation and delivery capability. With over 230 years of experience and our worldwide network of suppliers, we can usually provide you with an alternative source of supply within a fairly short time. Of course, a secondary supplier can also be included in the supply process as a purely safety measure in order to avoid the risk of lost production. Having a well-established secondary supplier gives you the flexibility to react quickly to problems with your first-party provider and not to be dependent. From our long-term experience, we know that nowadays many audits attach great importance to continuous and secure production and delivery capability.
Storage of APIs and Excipients
In order to be more flexible for you and to be able to react as quickly as possible to short-notice scheduling changes, we are currently working on the qualification of our warehouse for active pharmaceutical ingredients. As a company which is working in the pharmaceutical industry for several years, we are aware that the correct storage and handling of the goods is very important. For this reason, we have decided to build a warehouse, in connection with our new building, that meets the high requirements of the pharmaceutical / GMP warehousing and provides the perfect environment for our customers’ products. Thus, we can continuously check the product and process safety. Since the beginning of 2018, following a positive inspection by the government of Upper Franconia, we are the proud owner of the GDP certificate (Good Distribution Practice). In order to be prepared for the future, we have created a separate storage space for APIs (Active Pharmaceutical Ingredients). This offers new capacities to provide you with the appropriate APIs and to be able to respond even more flexibly to your needs. In addition, we ensure the quality and integrity of our products at all times through extensive documentation (incoming goods and goods issue logs, goods receipt analysis [product-dependent], pest control, temperature mapping) and are pleased to pass this data on to you.