Other deficiencies (German translation: sonstige Mängel) are violations of the requirements of Good Manufacturing Practice (GMP) that do not directly affect the quality, safety or efficacy of the product. This category of deficiencies is considered less dramatic than critical or major deficiencies, but they must also be remedied in order to prevent the potential deterioration of the quality management system.

The following are a few examples of violations, that can be classified as other deficiencies:

• Minor deviations in the documentation that do not affect the traceability of the production process or product quality.
• Minor deviations in the cleanliness of the production facilities that do not jeopardize product quality.
• Minor deviations in staff hygiene that do not affect product safety.
• Rare cases of missing signatures on documents, provided all other information has been recorded correctly.
• Inconsistencies in labeling or packaging (German translation: Verpackung) that do not affect the identification of drugs or their use.

Other deficiencies may have the following consequences:

• The company being ordered to initiate corrective measures to improve the pharmaceutical quality system (translation into German: pharmazeutisches Qualitätssystem).
• Regular checks and monitoring of processes so that minor deficiencies do not accumulate and grow into major problems or more serious deficiencies.
• Possible recommendations for optimizing processes and documentation without the need for immediate action or suspending production.

Although other deficiencies are considered less significant, if they occur frequently, they can be an indication of systemic weaknesses and possibly lead to more serious violations. They must therefore also be remedied as part of the general quality management strategy.

If a GMP inspection by foreign regulatory authorities is scheduled at your site, our professional pharmaceutical interpreters are at your disposal! We ensure smooth communication between the team of inspectors and your company’s team.

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