This convenient document contains in-depth background information about planning and carrying out audits. In addition it contains a checklist with more than 700 questions typically asked during audits or inspections.
It is worth using checklists to deal with the questions that a GMP inspection may typically bring up. These can be considered carefully beforehand, e.g. which internal documents need to be kept at hand for a certain question – this will save some moments of panic during the inspection.
The checklist is a catalogue of typical general questions, which may be asked during an inspection. The questions are referenced to the corresponding GMP regulations. In cases of doubt, the relevant original text can be quickly found. The information sources include the 21 CFR 210/211/11 as well as the EU-GMP-Guide Parts I and II.
The GMP Audit Checklist works great for both sides - the auditor and the inspected company. It facilitates an efficient preparation for
- an audit or an inspection to come
- your own GMP audit of suppliers and subcontractors.
Click & View: GMP-Audit-Checklist
- pharmaceutical manufacturers