Quay Pharma Completes FDA Pre-Qualification Inspection
The company announced that its facilities and laboratories have completed FDA pre-qualification inspection.
On July 19, 2016, Quay Pharma announced that its laboratories and manufacturing facilities have completed FDA pre-qualification inspection. The inspection confirmed that the company’s systems are GMP compliant and no deficiencies were identified. Quay recently invested £3 million (approximately $3.93 million) in GMP manufacturing suites. The company also recently received a Commercial License from the Medicines and Healthcare Products Regulatory Agency.
Source: Quay Pharma
Specification Equivalence—A Practical Approach
December 30th 2024In this first of a four-part series, the authors provide an introduction to a practical approach for establishing specification equivalence. The regulatory basis and compliance examples from FDA observations and warning letters are included to support the need for an effective process.
