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Critical Pharmaceutical Contract Manufacturing Quality Standards

Pharmaceutical contract manufacturing requires a great deal of oversight and attention to detail. The manufacturing process of medicine for the general public is a highly regulated activity and must be taken seriously by all parties involved. Drug research companies, developers, and manufacturers can work together to ensure that all quality standards are met. Before you put together a potential partnership with a company that specializes in pharmaceutical contract manufacturing, here are some things to consider.

Ensuring Quality

Critical Pharmaceutical Contract Manufacturing Quality Standards

Critical Pharmaceutical Contract Manufacturing Quality Standards

The most important part of pharmaceutical contract manufacturing is quality. The manufacturing process should follow all industry guidelines when it comes to safety and standards. The FDA governs all pharmaceutical contract manufacturing in the United States. Before you choose a manufacturing partner, it’s important to have a written agreement in place that ensures your company is getting the highest quality product. Within the agreement, there should be language that refers to the Current Good Manufacturing Practice, or cGMP, published by the FDA. The agreement should explicitly state how the manufacturing company will comply with the standards from the cGMP.

Choosing the Right Facility

Quality pharmaceutical contract manufacturing begins with an optimal physical space. The manufacturer’s facility should be able to handle the demands of the drug manufacturing process. It should also contain high-quality equipment that operates consistently. The manufacturer should have a plan to avoid issues such as cross-contamination. There should also be a plan in place to ensure product quality, such as testing or sampling.

Managing Raw Materials

The drug manufacturer should also have a specific method of managing all materials. In pharmaceutical contract manufacturing, there are certain guidelines that must be followed in order to use certain ingredients. Generally, this includes finding the right supplier, managing ingredient inventory, labeling materials, storing items, and transporting materials from the supplier to the manufacturer. The drug company must be aware of where all materials are coming from. This can help prevent issues that could impact the drug manufacturing process and the quality of the product.

Looking at Laboratory Issues

Pharmaceutical contract manufacturing also involves an extensive testing process. The manufacturer should have their own laboratory within the facility. The drug company must learn more about the manufacturer’s laboratory standards to make sure they fall in line with the cGMP. All lab equipment should be in peak working condition and clean. Audits must be performed routinely to avoid potential problems.

Putting the Product First

Critical Pharmaceutical Contract Manufacturing Quality Standards

Critical Pharmaceutical Contract Manufacturing Quality Standards

At the center of all pharmaceutical contract manufacturing is the product itself. Before any contract agreement is reached, the drug company must consider the specifications of the product and whether or not the facility has the capability to produce it. There should be a specific timeline that needs to be followed as the product is developed and manufactured. Key staff members from the product development team should be able to visit the facility and see firsthand how things are going throughout the process.

Focusing on Documentation

Critical Pharmaceutical Contract Manufacturing Quality StandardsCritical Pharmaceutical Contract Manufacturing Quality Standards

Critical Pharmaceutical Contract Manufacturing Quality Standards

Documentation is another key component of a successful agreement for pharmaceutical contract manufacturing. Before any work happens, all expectations should be included in writing in the agreement between the manufacturer and the drug company. Each party’s responsibilities should also be included in the agreement so there are no misunderstandings and problems. This way, throughout the process of development, manufacturing, testing, and distribution, each company understands what to do.

Getting to the Distribution Stage

Critical Pharmaceutical Contract Manufacturing Quality Standards

Critical Pharmaceutical Contract Manufacturing Quality Standards

The last big step of pharmaceutical contract manufacturing is the distribution stage. In many cases, the contracted drug manufacturer will guide the drug company through this final part of drug production. The agreement should include information about what to do if there are snags during distribution. Sometimes, there may be an issue with a product, an ingredient shortage, consumer complaints, or more. A company with a strong record of pharmaceutical contract manufacturing should have a plan in place to manage this step.

Making Changes to the Process