by shannon | Jul 22, 2021 | Articles
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...
by shannon | Jun 24, 2021 | Articles
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...
by shannon | May 13, 2021 | Articles
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...
by shannon | Apr 22, 2021 | Articles
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...
by shannon | Apr 9, 2021 | News and Events
Bora Pharmaceutical Laboratories, a division of Bora Pharmaceuticals, has added roller compaction technology to its solid dose capability offerings at its Zhunan, Taiwan contract manufacturing and packaging facility. The Zhunan facility is a leader in the manufacture...
