An SOP (short for standard operating procedure; in German: Standardarbeitsanweisung) is a formal document that contains detailed instructions and procedures in order to ensure compliance with Good Manufacturing Practice (GMP) standards in the pharmaceutical industry. These standard operating procedures are an integral part of quality systems and provide consistent and standardized approach guidelines for the various operations and processes that impact product quality and safety.

The most important aspects of standard operating procedures include:

• Compliance with guidelines: SOPs are developed in accordance with the relevant GMP regulations that govern the manufacture, quality control (German translation: Qualitätskontrolle) and handling of pharmaceutical drugs.
• Quality control: Control, analysis and monitoring methods are defined in SOPs to ensure a high level of product quality.
• Documentation: SOPs require the documentation of all steps in the execution of a procedure, including the results and deviations (translation into German: Abweichungen), which facilitates traceability and transparency.
• Equipment and material requirements: SOPs specify which equipment, tools and materials are needed for tasks to be carried out properly.
• Training: Employees are trained in accordance with SOP requirements in order to ensure that procedures are carried out correctly.
• Safety: Compliance with safety regulations, including the handling of chemicals and equipment, is also an important part of standard operating procedures.
• Reviewing and updating: Standard operating procedures are regularly reviewed and updated in order to incorporate changes in guidelines, technology and legislation.

It is important to note that SOPs (standard operating procedures) in the context of GMP play a key role in ensuring the quality, safety and compliance of drugs and medical devices (German: Medizinprodukte) with standards and regulatory requirements.

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