AmPharmCo Contract Packaging

Current Good Manufacturing Practices (cGMPs) are at the core of AmPharmCo’s commitment to building quality into every product while meeting the highest level of regulatory compliance. AmPharmCo’s capability as a contract manufacturer is broad in nature with in-house provision for full compendial testing of raw materials, packaging components and finished products, as well as on-going Stability Studies for Drug Product based on current FDA/ICH (International Commission on Harmonization) guidelines.

Validation Services include analytical method validation, vendor validation, equipment validation, process validation, cleaning validation and packaging validation. All validations are conducted and documented according to current GMP/ICH guidelines.

AmPharmCo offers formulation and deformulation capabilities to provide new formulations per client requirements, or to deformulate and update existing product formulas. The Formulations Department provides lab batches for client approval. Pilot to scale up manufacturing procedures are developed and validated after client approval is received.

AmPharmCo’s mission is to achieve a “Total Quality Product” by following current company Good Manufacturing Practices in the manufacturing and packaging of product. The integrity, quality, safety and effectiveness of the final product being assured though a validation program providing a high degree of confidence that the process will consistently produce a product meeting pre-determined specifications and product attributes.

AmPharmCo is very proud of the TEAM effort fostered by management and maintained by it’s employees in which Production, Quality Control and Quality Assurance work together to achieve the common goal of producing a quality product. We believe that it is this “small company/family/team” philosophy and attention to the client that sets AmPharmCo apart in contract manufacturing.