Inspection of suppliers

 

(See chapter 17 Contract Manufacturing and Analysis.)

18.G.1 Purpose of the supplier inspection

Supplier inspections are used to verify on-site whether the supplier is in the position to manufacture and supply starting materials, labelling or packaging materials of the desired (ordered) quality.

Chapter 5.26 of the EU GMP Guideline requires that starting materials should only be purchased from "approved" suppliers. The same also applies, according to chapter 5.40, to primary and printed packaging materials. The pharmaceutical manufacturer is responsible for the starting materials, labelling and packaging material used and must control their quality.

In this respect, inspections offer a way of deciding whether to approve the supplier and about the level of inspection effort required.

The EU GMP Guideline does not give any more precise specifications regarding the scope of the inspection of starting materials. However, at least the indentity should be checked. The extent to which the customer choses to rely on the supplier's quality control and the resulting certificates therefore depends on the result of the inspection of the supplier. Thus, the result of the inspection of a supplier leads to more than simply the decision whether a supplier is able to supply a product or not. The inspection also makes an important contribution to the mutual trust between supplier and customer. An inspection can help to build such mutual trust so both sides get to know and appreciate the situation at the outset and the specific problems of the other, and are thus in the position to improve the quality of the product together.

The pharmaceutical manufacturer must, therefore, recognise that it is not simply a case of purchasing starting materials, labelling and packaging material as cheaply as possible. A medicinal product of consistent and reliable quality can only be achieved with high-quality starting materials.

In addition to these "classic" supplier inspections, the inspections of equipment manufacturers as part of design qualification, and the inspection of software manufacturers are becoming important. The purpose of these inspections is the same: the pharmaceutical manufacturer, as the customer, wants to ascertain on-site, before placing an order, that the goods will satisfy the requirements he has set.

18.G.2 Carrying out the supplier inspection

Before carrying out the initial inspection of a new supplier, the pharmaceutical manufacturer should compile the basic information about the future contract partner. As for contract acceptors, this can take the form of a questionnaire to be filled in by the supplier and to be considered during the inspection.

The inspection is carried out on the basis of a checklist. The pharmaceutical manufacturer should first establish what it considers to be the principal considerations regarding the starting materials and/or packaging material to be supplied (compare figure 18.G-1) in the form of "mandatory" and "optional" requirements.

Supplier inspections have been carried out by customer partnerships, in particular for primary packaging material manufacturers. These reduce the cost to suppliers and similarly to customers. For this type of joint inspection, however, all the parties involved must first be in agreement about the requirements. It is essential to draw up a joint checklist and agree on the classification of deficiencies, particularly if companies not involved in the inspection wish to forego their own inspection on the basis of the inspection report.

Samples of the starting materials and/or packaging materials in question should be investigated before the inspection. If this has been agreed with the supplier, sampling from the production underway during the inspection can provide valuable additional information. Evidence of the comparability of the analytical investigations carried out by the supplier and by the customer must be demonstrated in order to justify the pharmaceutical manufacturer reducing the controls it carries out later. This presupposes that the supplier, as specialist for the products it distributes, discloses to the pharmaceutical manufacturer the analytical procedures used, which unfortunately cannot be taken for granted in practice.

The pharmaceutical manufacturer will not always have the required knowledge in-house to control the supplier sensibly. This applies, for example, to starting materials manufactured biotechnologically, starting materials of human or animal origin and also to software (compare figure 18.G-2). In these cases, people with expert knowledge (consultants, experts) must be called in, if the pharmaceutical manufacturer does not want to hazard purchasing the goods "blind".

An important point to check during the inspection is how the supplier handles changes. This applies to changes initiated by the pharmaceutical manufacturer and to those made by the supplier. The inspection should control by means of selected examples whether the processes (who is responsible for which tasks, who assists, who should be informed?) are clearly established and, in particular, whether there are smooth supplier-customer interfaces.

The issue of how the supplier handles complaints it receives is also important for maintaining mutual trust between supplier and the pharmaceutical manufacturer. The inspection can be used, at the same time, to trace previous complaints on-site, in particular what measures the supplier has taken to determine the cause of failure and prevent errors in future.