Quality Assurance

QA insures the products from our company are prepared responsibly and in accordance with ISO 9001 standards.

Activities and Responsibilities:

• Release of qualification and validation protocols;
• Release of documents: specifications; Master Batch Records, SOPs;
• Batch reviewing and releasing, archiving;
• Release of batch records;
• Change control, deviation control, investigations;
• Approval of validation protocols;
• Training;
• Internal audits, compliance;
• Supplier qualification and supplier audits;
• Claims, recalls, etc.

Quality Control

In our laboratories and workshops, we provide quality analysis and inspection though the control of the whole process to make sure every single batch of our product meets the requirements from our customer.

Activities and Responsibilities:

• Development and approval of specifications;
• Sampling, analytical check and release of raw materials, intermediates and cleaning samples;
• Sampling, analytical check and approval of APIs and finished products;
• Release of APIs and final products;
• Qualification and maintenance of equipment;
• Method transfer and validation;
• Approval of documents: analytical procedures, SOPs;
• Stability tests;
• Stress tests.