The standard specifically governs the Quality Management Systems (QMS) for manufacturers of primary packaging materials for medicinal products. It essentially merges the requirements of ISO 9001:2015 with the rigorous Good Manufacturing Practice (GMP) principles necessary for pharmaceutical and medical device safety. Key Requirements of ISO 15378
You can download a free PDF of ISO 15378 from the official ISO website or other online sources. iso 15378 key pointspdf free