Conformity assessment (German translation: Konformitätsbewertung) is a procedure for checking and documenting the whether products, processes or services comply with defined standards, specifications and legal requirements. In the pharmaceutical industry, conformity assessment is an extremely important element of the pharmaceutical quality system, as it ensures the safety and efficacy of products as well as compliance with GMP requirements.

Conformity assessment can be voluntary or mandatory and can be carried out in two ways: by issuing a declaration of conformity or by obtaining a certificate of conformity

• When a declaration of conformity (German: Konformitätserklärung) is issued, it is the responsibility of the manufacturer or service provider to provide evidence that the product or service complies with the specified requirements. They are free to commission an external organization to provide the evidence but nevertheless remain liable for its accuracy. The certification body is only responsible for recording the declaration.
• By issuing a certificate of conformity (translation into German: Konformitätszertifikat), the certification body also assumes responsibility for the conformity of the certified product or service with the applicable standards, regulations and requirements.

Main aspects of the conformity assessment procedure:

• Conformity check: The conformity assessment procedure involves evaluating the compliance of all steps in production, quality control and documentation with internal and external standards such as GMP or ISO as well as other legal requirements.
• Testing: During the conformity assessment, laboratory testing is carried out to ensure that the products meet the required parameters and specifications. This includes stability tests (German translation: Stabilitätsprüfungen) as well as tests of the biological activity and purity of substances, be they starting materials or excipients, semi-finished products or finished drug products.
• Documentation: The records of the test and measurement results and the inspection reports must be properly documented.
• Evaluation of the production processes: In addition to checking finished products, conformity assessment also includes testing production processes in order to ensure that they comply with established procedures and standards.
• Qualification and calibration of systems: Part of the process includes the regular qualification and calibration of systems to ensure the accuracy and stability of the production processes.

The importance of conformity assessment:

• Ensuring product quality and safety: Conformity assessment minimizes risks associated with production processes and product quality. This is particularly important in the pharmaceutical industry, for example in contract manufacturing.
• Compliance with regulations: Regulatory authorities (German translation: Aufsichtsbehörden) require verification documents on the conformity of raw materials and semi-finished products.
• Strengthening customer trust: Certificates of conformity verify that products are safe and meet the expectations of customers and patients.

Application of the conformity assessment:

In the pharmaceutical industry, conformity assessment is carried out at various stages of production, from the inspection of raw materials to finished products, including quality management procedures and the documentation of corrective actions. This process is part of a comprehensive risk management concept and ensures that products meet high quality and safety standards.

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