FACILITY INSPECTION

• ILS recognizes that Good Manufacturing Practice (GMP) inspections are one of the fundamental ways by which a regulatory authority can ensure that medicinal products are being manufactured to high quality standard and compliant with GMP regulations.
• Pharmaceutical manufacturing facilities must be approved by local authorities to adhere to GMP requirements according to the WHO’s guidelines. However, many countries require additional inspections by their own ministry of health supervisors before a pharmaceutical product can be imported into that country. ILS does pre-inspections on all the pharmaceutical facilities used and determines whether the facility will meet the requirements in the markets of their clients.
• During any inspection of a pharmaceutical manufacturing facility all aspects of the WHO’s GMP guidelines for pharmaceutical products are checked in order to ensure that the facility follows those guidelines. Some of the main points that should be checked for compliance are:

- Quality Assurance
- Sanitation & hygiene
- Qualification & Validation
- Complaints & Recalls
- Personnel & Training
- Premises & Equipment
- Materials
- Documentation


• ILS has the experience and the knowledge to help manufacturers prepare for the inspections and has successfully completed inspections and registrations worldwide.