Supervisory authorities must propose yearly audit plans to ensure that the companies subject to monitoring are inspected within the required time interval. Audit planning is also advantageous in pharmaceutical companies; to cover the quota for the selfinspection and also to plan the audit of contract manufacturers and suppliers. The basis for audit planning is a current list of all companies in accordance with figure 8.
When establishing the audit sequence, the significant factors are that the audits follow a comprehensible pattern and have defined criteria. In the past, a calculation mode for determining the audit sequence has been used in a regulatory inspectorate and has proven its worth in practice many times: Priority P of the inspection is determined from the total time T (time in years since the last inspection), risk R (classification of the plant according to type of activity), which agrees with factor 2 of the equation due to its significance, and compliance C (degree of conformity of the company with the requirements), cf. figure 8.
The time passed since the last inspection should not exceed 2 years for inspections by the authorities. Inspections of facilities which process blood and blood products must be carried out once a year. However, a longer frequency can be determined for designated companies, such as distributors without own drug product manufacturing, or wholesale dealers. The main decisive factor for determining the priority of the inspection is the type of products manufactured in the company and the activities involved, figure 9.
The inspector responsible then assigns a risk number to the company. Experience from the previous inspection (willingness of the company to cooperate, established deficiencies, performed regulatory offence procedures) ultimately determine how soon the next inspection is necessary. Note that the company's high conformity (compliance C) with the legal requirements is showed with a low compliance number (cf. equation 1)
As part of the audit preparations, the auditor compiles the information required for the company to be inspected. The company description is a suitable basis for learning about the company. The submitted company description is checked for accuracy (plausibility), completeness and if it is up-to-date. The availability and readability of all-important appendices, such as plans, flow charts, water processing and air conditioning systems is checked.
Figure 11 gives an overview of further preparations necessary for the audit. The measures shown can be adapted to the respective ratios and used by the companies for audit preparations for contract manufacturers and/or suppliers.
In good time before the audit, the company is informed of the planned chronological sequence, so that it can compile the necessary documentation and name the contact persons for the areas to be inspected.
An audit is carried out depending greatly on the reason (e.g. routine, re-inspection, preapproval) and the type of audit (system/product/area/procedure-oriented).
An audit typically consists of:
Dr. Michael Hiob and Max Lazar
The text is an excerpt from our GMP-Audit-Checklist