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AmPharmCo Capabilities
AmPharmCo provides pilot to scale-up manufacturing and validation of the compounding and filling processes for drug, topical, liquid, lotion, gel, cream, ointment and cosmetic products according to the client’s formula.
AmPharmCo’s R&D Department will also deformulate or formulate products according to the client’s needs. Our formulation chemist draws upon many years in the human, cosmetic and veterinary health care industries, and can provide new formulations per client specifications and timely deformulation services.
In the last 2 years 63 new formulations and deformulation projects have resulted in marketed products for clients.
AmPharmco also has the capability, and is currently pursuing, prescription products with Abbreviated New Animal Drug Applications requiring FDA pre-approval.
All product formulation and filling processes are validated according to GMP requirements. Other validation services include method validation, vendor validation and cleaning validation. All validation are performed and documented per current GMP/ICH guidelines.
Ongoing Stability Studies are conducted on all drug products manufactured at AmPharmCo. Studies are performed with sample storage at 25ºC/60% relative humidity and accelerated studies at 40ºC/75% relative humidity. Intermediate stability studies at 30ºC/60% relative humidity are also conducted as necessary or client required. All stability studies are conducted and documented according to SOPs that reflect current GMP/ICH guidelines.
The Microbiology Department is primarily involved with routine monitoring of the USP Purified Water System, raw material and finished product microbial testing. Testing capabilities include USP test methods, preservative challenge testing, antibiotic methods, etc. Microbial monitoring of the manufacturing environment assures that product is consistently made and packaged under clean conditions. Methods and SOPs are in place for microbial identification using standard ATCC cultures and product preservative challenge methods are available.
