Critical deficiencies are gross violations of the requirements of Good Manufacturing Practice (GMP) that have a direct impact on the quality, safety or efficacy of a drug and may pose a risk to patient health. As such deficiencies can have serious consequences such as product recalls, the suspension of production or even the withdrawal of manufacturing authorization, they must be rectified immediately.

Deficiencies are identified during GMP inspections carried out by the competent authorities.

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

• Non-compliance with sterility standards in the manufacture of sterile drugs.
• Improper storage of raw materials or finished products, which can cause them to become unsuitable for production or exhibit altered properties.
• Lack of monitoring of critical process parameters that influence the safety and efficacy of a drug.
• Using raw materials that are either uncertified or of inferior quality.
• Inadequate quality control, which could lead to defective or ineffective drugs being placed on the market.
• Lack of CAPA measures to eliminate violations identified during an audit or GMP inspection.

Critical deficiencies can have the following consequences:

• Temporary or permanent closure of production plants.
• Product recalls.
• Financial penalties and fines.
• Loss of trust among regulatory authorities and consumers.
• Suspension or withdrawal of manufacturing authorization and/or distribution authorization.

Critical deficiencies are considered the most serious type of violation and require immediate and appropriate corrective action.

If your company is preparing for a GMP inspection by foreign regulatory authorities, our professional pharmaceutical interpreters are at your disposal!

We ensure smooth communication between the group of inspectors and the company's representatives.

We also offer various types of consultancy services, representation of foreign pharmaceutical companies and distribution of their products in Germany. Thanks to our many years of cooperation with several hundred companies worldwide, we can also help jobseekers find vacancies in the pharmaceutical industry. Would you like to find a new job in your dream country? Contact us for more information!