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What is Process Validation?

What is Process Validation?

The Process Validation (PV) Guidance from the FDA (January 2011) adopts the product lifecycle concept, emphasizing the expectation that process validation starts with process design and carries throughout the entire lifecycle of a commercial product. During the process qualification stage, the process design is evaluated to determine if the process is capable of consistently delivering quality...

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What You Need To Know About Equipment Qualification

What You Need To Know About Equipment Qualification

Equipment qualification is critical in the pharmaceutical industry. The equipment not only includes manufacturing equipment but testing and sampling equipment also to name a few. Even the slightest error or misuse can pose a costly risk and time delay for the pharmaceutical product owner and their manufacturer. So, what is equipment qualification? It is a series of inspections, tests, and...

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What Is The Benefit Of Doing An Engineering Batch In The Pharmaceutical Industry?

What Is The Benefit Of Doing An Engineering Batch In The Pharmaceutical Industry?

Not going to invest in your own new equipment or building a new manufacturing line? Engineering trials and CMOs are here to help! So, your new product is ready for the next step – commercial manufacturing production. You have decided not to invest in new equipment or building a new manufacturing line. You’re now looking to partner up with a contract manufacturing organization (CMO) for your...

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Pharmaceutical Technology Transfer: Problems and Solutions

Pharmaceutical Technology Transfer: Problems and Solutions

Technology transfer aims to commercialize products successfully at your contract manufacturing organization (CMO) partner site. This means the manufacturing, analytics, packaging, relevant documentation, and professional expertise should be involved in the process. It is inevitable that problems and challenges can be encountered during the technology transfer of any pharmaceutical product....

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