PTS Consult

The experts with PTS Consult have more than 20 years practical experience within the range quality management/quality Assurance in the chemical and pharmaceutical industry. This experience we put and offer to you at the disposal to your enterprise the following competent Unterstuezung with inspections/audits as well as services for the conversion of GMP Compliance activities. The experts with PTS Consult have experience of many years at the time of the execution of internal audits, the preparations of an enterprise on national and internalionale authority inspections (also FDA) and the execution of authority and certification inspections (DIN EN ISO).We can accomplish therefore following inspections/audits in your order: - supplier audits with critical suppliers - internal audits in its enterprise (GMP/DIN EN ISO) - Mock inspections for preparation on authority inspections abroad the in and - Due Dilligence inspections with planned trusts or planned enterprise assumptions. GMP Consulting PTS Consult ordered over 20 years experience within the range quality Assurance/GMP and accompanied leading quality Assurance functions in considerable global Pharma or Biotechunternehmen. This permits to offer it to PTS Consult its customer an extensive advisory service achievement within all ranges of the GMP Compliance.We support our customer with the following activities: - pre and reinforcement on authority inspections - the answer of 483 Observations (Monita of the inspections) or warning type character by the FDA - of the conversion of quality of system Improvement programs (QSIP), a FDA requirement - the implementation and the continuous advancement of the GMP systems - of the planning and realization of pure areas and their qualification - the implementation and validating of aseptischer processes - of validating of computer-assisted systems (computer systems) we support you in line with standard usage with the solution of concrete questions:- production/Review of SOPs (standard work instructions) - development/evaluation of qualification/validating strategies - development and conversion of hygiene programs - development and conversion of Environmental monitoring programs - development and conversion of CHANGES control and deviation management systems speaking it us on! We find a properly matching solution. Partner Dr. Klaus von Jan pure hard Schnettler