Sente Life Sciences can execute internal GMP and GDP audits for various purposes:

• As preparation for a customer audit
• As preparation for an authority inspection
• As a tool for evaluation the quality management system and its implementation

Each internal audit by Sente Life Sciences will be accompanied by a clear report and will be discussed with the client. The report describes the deficiencies and the related regulations or guidelines and gives recommendations on how deficiencies can be resolved.

Additional to execution of a single audit, Sente Life Sciences can also support you in establishing an internal audit year planning, and execute the audits if desired together with your internal staff.

As Marketing Authorization Holder, Manufacturer or Wholesaler you have the responsibility to deliver products and services of high quality, and complaint to GMP and GDP regulations. Assessing and documenting the quality of your suppliers and the risks related to the processes in the supply chain is required to take that responsibility. An important part of this is making an audit plan and execution of the planned audits.

Sente Life Sciences has the expertise to execute GDP and GMP audits. This includes manufacturers of APIs and excipients, intermediates and packaging materials. Additionally, Sente Life Sciences is experienced in auditing Contract Manufacturing Organizations (CMOs) manufacturing oral solid dosage forms, semi-solids, sterile and aseptically manufactured products, biotech products and Contract Packaging Organizations and Contract Laboratories. Also (pre-)Wholesale Distributors are audited by Sente Life Sciences.

Sente Life Sciences can set up a Supplier Qualification Program together with you including risk analysis, audit year plan or multi-year planning for all your suppliers and manufacturers. The SOPs needed can be written, if desired together with your staff members.

Sente Life Sciences is experienced in writing Technical or Quality Agreements and Manufacturing and Supply Agreements. We can support you in this.