To ensure the sustainability of its performance, Seratec must monitor, evaluate, analyze and regularly review its processes and procedures. Quality and generated performance indicators are used at Seratec, associated with a criterion and designed to observe changes at defined intervals.

What are the measures of performance and quality indicators ?

The ISO 9004 management by quality approach applied to the pharmaceutical industry makes sure stakeholders’ needs are satisfied and expectations are met by fulfilling the strategies of the company and complying with legal and regulatory requirements. It thus covers all sectors and all appropriate levels to achieve the objectives of Management. ISO 9004 evaluates the performance of the company in this achievement by using Key Performance Indicators (KPI).

For this, the “Pharmaceutical Quality Metrics” (PQM) or measurement methods and pharmaceutical quality indicators, are both objective measures of the quality of a product or procedure in its capacity to conform with its intended use on the patient. These are also an objective measure of the quality of a site in its capacity to produce pharmaceuticals. Lastly, these are objective measures of the effectiveness of the pharmaceutical quality system that are useful in the inspection process.

In this, the indicators must focus on measurable, accurate and reliable information.

It is indeed necessary that these PQM measures be sufficiently developed to meet the expectations of the authorities, especially since they apply to areas that represent the manufacturer’s business, and that they make sense in terms performance as part of a continuous improvement approach within the meaning of ICH Q10 so that the manufacturer can evolve towards the desired state.

The European Authorities, especially in France (see ANSM, use extensively an approach based on quality risk management to carry out their inspection processes, in particular to evaluate the level of achievement of the desired state.

The “Food and Drug Administration Safety and Innovation Act” (FDASIA) from 2012 also gave the FDA new tools to encourage innovation in the manufacture of pharmaceutical products and to reduce the risk of drug shortages. The first four sections of the Act have established a fee system for the registration of pharmaceuticals to fund the review of files and speed up their marketing. For the safety of the pharmaceuticals supply chain, Section 705 of the Act implemented an inspection system based on risk, while Article 706 amended the document needs to be reasonably available prior to or at the time of the inspection. Lastly, the Act established the involvement of stakeholders in the processes and decisions of the FDA. A collaboration was thus established, in particular, on ‘Pharmaceutical Quality Metrics’ with organizations such as the ISPE (International Society for Pharmaceutical Engineering), the PDA (Parenteral Drug Association), APIC (APIC QWG) and other stakeholders.

Why use quality measures and indicators ?

Although regularly used in all industries, PQMs are based on requirements of good manufacturing practices for the pharmaceutical industry, including product quality journals and their source data, to make them available to inspectors. These measures must be implemented to ensure early detection of drifting; to focus resources in a particular area; and to combat shortages of pharmaceuticals for patients.

So what are the right indicators ?

Good indicators are those that are proportionate, informative (and therefore essential), which make it possible to identify, determine, understand, evaluate, anticipate and monitor the performance of a manufacturer.

Seratec has selected several performance measures deemed appropriate for our policy of continuous improvement. These measures can be organized into three groups:

• Historical measures (past-up to present performance or lagging metrics);

• Anticipatory measures (future performance or leading metrics) ;

• Measures of fulfillment of the Seratec strategy such as the quality policy;

They cover key topics such as problem solving, product measurements, laboratory efficiency, customer satisfaction, the performance of suppliers and subcontractors, knowledge management, the achievement of planned results…

In 2012 we implemented these quality indicators to use a common language at Seratec for measuring progress and setting clear objectives for all. This is the way to achieve some regulatory flexibility, since an inspection and providing indicators establishes a degree of confidence of the Authorities and other stakeholders for the manufacturer.