GMP Manufacturing

Aceto Manufacturing


Aceto services a variety of industries that all have differing governing manufacturing best practice and guidelines. Aceto’s global manufacturing facilities are dedicated to certain market segments and the facilities are all accredited with the relevant certifications to manufacture quality products for that market segment only. Selection of our manufacturing facility will depend on the application and industry of the product and the quality requirements associated with that specific material.


For the life science industry we can offer GMP and non-GMP development services to provide you greater flexibility and speed. With state-of-the-art facilities, we are able to focus on lab-scale experiments with batch sizes ranging from <1kg+.

 

By deliberately ensuring good integration of all technologies in both the GMP and non-GMP facilities, we can conduct non-GMP work efficiently then transfer rapidly to GMP manufacturing. Essentially, our seamless process speeds up your overall project timeline to clinic and removes risks from your clinical manufacturing activities.


We acknowledge the importance of GMP compliance for our clients, and all of our products and services are developed to meet our customers’ expectations in terms of high-quality standards. We are committed to providing services and products that strictly adhere to the required GMP standards. GMP standards are also essential for all  Aceto’s services, including GMP custom ingredient development, GMP manufacturing and GMP custom toll manufacturing.


The GMP guidelines regulate quality management in the production and marketing of active pharmaceutical ingredients and excipients. These products require a Quality Management System that meets the GMP standards. We utilize one of the world’s leading automated QMS, named Master Control, which helps achieve our quality and compliance goals. We sustainably meet pharmaceutical and biopharmaceutical standards through the consistent implementation of our standard operating procedures (SOPs) and Quality Management System, which ensure GMP compliance.


The scheme comprises the following:


  • GMP Standards for excipients (either EXCiPACT GMP annex to ISO 9001:2015, or NSF/IPEC/ANSI 363-2014 GMP- includes requirements of ISO 9001:2015).
  • GDP Standard for excipients (EXCiPACT GDP annex to ISO 9001:2015).
  • Certifying Body quality system definition and qualification process.
  • Auditor Competency definition, training course, exam and registration process.


Check out our manufacturing sites:

Amedabad - Finar
Eugene Polk - Cascade
Eugene Woodruff - Cascade
Grand Island - IsleChem
Montreal - A&C
Runcorn - Syntor

Or CONTACT US to learn more about Aceto's GMP manufacturing.