Major deficiencies are violations of Good Manufacturing Practice (GMP) requirements that pose a potential risk but do not directly affect the quality or safety of a drug. Major deficiencies usually indicate complex problems in quality control and/or the production process. If they are not rectified in time, they can have far-reaching consequences.

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

• Incorrect or incomplete records, making it difficult to verify whether the products meet the specified standards.
• Incorrectly calibrated equipment, which can affect process stability but has not yet led to obvious quality defects in the product.
• Insufficient staff training, which increases the risk of errors in the future.
• Violation of the SOPs for material storage, which leads to non-compliance with the requisite storage conditions even though the quality of the manufactured drugs has not yet been compromised.
• Lack of regular self-inspections or audits to identify and rectify deficiencies in the pharmaceutical quality system.

Major deficiencies can have the following consequences:

• The manufacturer may be ordered to implement corrective and preventive action (CAPA) in order to ensure that the problem no longer occurs.
• During follow-up GMP inspections, GMP inspectors and regulatory authorities may be particularly vigilant.
• The production or distribution of products may be restricted if measures to rectify problems are not taken in time.

Major deficiencies are indicators of complex problems. They must be rectified so that they do not develop into critical deficiencies. As a rule, regulatory authorities give a company a reasonable amount of time to rectify the problems identified and then require a report on the implementation of the corrective measures.

If your company is preparing for a GMP inspection by foreign regulatory authorities, our professional pharmaceutical interpreters would be delighted to assist you! They ensure smooth communication between inspection team and your company.

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