Part 1. General information on company
Part 2. Description of the inspection
Part 3. Observations
Part 4. Conclusion and recommendation
Appendix 2 of the WHO Provisional Guidelines in the Inspection of Pharmaceutical Manufacture provides an example of the type of report that can be written after an inspection. You will find a copy of this text in your handout. The report should be divided into 4 parts as shown on this slide:
The first part:
General information about the company can be taken directly from the information provided by the company itself, provided it is annotated as such and verified during the inspection.
The second part should describe the progress of the inspection, listing all the parts of the factory, warehouse, laboratory etc that have been inspected.
The third part is devoted to observations, either negative or positive, including any major changes (improvements and deterioration) that have taken place since the previous visit. Negative observations should differentiate between poor systems and failure to comply with the system. An example is lack of cleaning in a particular area. Is it due to an inadequate SOP, or lack of compliance with an SOP that covers all aspects of cleaning.
Positive observations should be recorded A description of the process that is carried out particularly well and would be considered as examples of good manufacturing practice.
The final part consists of the inspectors’ summary and conclusion, including corrective actions and recommendations. You could also add any supplementary documentation as annexes to the report. (It is advised that you discuss the contents of part three and four with the company during the exit meeting, where possible).