General Statement

We focus on customer satisfaction and operational excellence.

We try our best to exceed our customer's specifications.

We consistently deliver top quality products and services.

QA Responsibilities

• Qualification and validation activities
• Control of documents
• Batch record review
• Product release
• Investigation of nonconformances
• Risk assessment
• Implementation of corrective and preventive actions
• Change control and customer notifications
• Training
• Internal, customer and regulatory audits
• Supplier qualification and audits
• Regulatory review of APIs and cGMP manufactured products
• Review and approval of final and raw material product specifications
• Review and approval of all manufacturing and packaging documents and operating procedures

QC Responsibilities

• Method development, and method validation
• Writing and approving quality control procedures and protocols
• Sampling and testing of raw materials and intermediates
• Chemical, physical, biological, and microbiological testing of final products
• Stability testing and management of ICH stability program

Quality Audits

We welcome quality audits by our customers and related authorities. Your feedback helps us to continuously improve our quality systems. During your audit we invite you to review and evaluate our many quality system programs that are designed to maintain product control and allow us to produce high quality products consistently.