Appropriate Control Strategies Eliminate the Need for Redundant Testing of Pharmaceutical Products Background To help ensure drug product quality and safety, national medicines regulatory authorities (NMRAs) in many countries have implemented, or are considering implementing, import testing requirements for pharmaceuticals, biological/biotechnology and vaccine products entering their countries. Historically such testing requirements may have been necessary to prevent the distribution of unsafe or nonconforming drug products.

Today, however, pharmaceutical, vaccine, and the biotechnology industries have developed and implemented robust quality management systems to ensure the identity, safety, purity and potency of its drug products throughout its manufacture and international distribution channels, thereby eliminating the need for this redundant testing.

Key Messages

The repetition of quality control testing for pharmaceutical, biological/biotechnology and vaccine products at the country level, or ‘import testing’, is unlikely to increase public health protection. It can delay batch release, reduce remaining shelf life and therefore increasing risk for a potential drug shortage. Also it does not prevent the entry of counterfeited products. Finally, it creates an avoidable burden for NMRAs, the pharmaceutical industry and the national healthcare systems, as recognized by several competent authorities who have taken measures towards reducing import testing.

Import testing should not be routinely required for the following reasons:

• Manufacturers have established appropriate control over their production through in-process controls, validation of the manufacturing process and release testing of the finished drug products, in line with internationally recognized good manufacturing practice (GMP) standards.
• Robust quality management systems (QMS) are in place and enforced, including appropriate validation, control and risk management strategies for the handling, storage, transportation and distribution of the finished drug products under good distribution practice (GDP) standards.
• The adequacy of a manufacturer’s quality oversight is ensured through reporting requirements as well as regular internal audits and inspections by competent NMRAs confirming the adequacy of the established processes and the compliance with the product license.
• Import testing does not increase patient safety. Practical implementation of import testing showed that the rejection rate induced by this local re-test is negligible, if any.
• Import testing introduces risks for the patients due to interruptions of the legitimate supply chain and potential delays in product distribution and patient access to important medicines.