cGMP Manufacturing
Anthem manufacturing facilities are strategically located on the same campus to enable efficient co-ordination across various functions. Our modern kilo lab and versatile pilot plant can carry out cGMP manufacturing in grams to multi kilogram quantities.
Our experienced chemists and engineers understand cGMP manufacturing
and regulatory requirements for custom synthesis.
Scope of GMP Projects include
• Development work
• Technology transfer documentation
• Analytical development
• Batch manufacturing record
• Analytical of rawmaterials, intermediates and final product
• Support for regulatory filing and DMF preparation
• Documentation review and release by QA
Quality Assurance and Regulatory Affairs
Anthem has established a quality assurance department to
oversee GMP manufacturing & testing services through routine
review of documents which include standard operating procedures,
batch records & laboratory records, analytical data etc.
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