GMP documentation is a system of instructions, protocols and reports used to document all aspects of the manufacture and quality control of drugs in accordance with the requirements of Good Manufacturing Practice (GMP). The documentation serves as proof that all production operations as well as the entire production process have been carried out correctly and that the quality of the product meets the specified standards.

The most important types of GMP documentation:

• Standard operating procedures (SOPs):
  
  • Contents: These documents describe the sequence of certain procedures or processes, such as manufacture, cleaning, packaging (German translation: Verpackung) or quality control.
  • Purpose: Ensuring that all processes in production are carried out correctly and consistently.
• Manufacturing regulations and instructions:
  
  • Contents: Describes all the steps involved in the manufacture of drugs, from receiving raw materials to the finished product.
  • Purpose: Ensuring that each production step complies with GMP requirements.
• Manufacturing protocols:
  
  • Content: these documents record the actions taken at each stage of production.
  • Purpose: Confirmation that production processes have been carried out correctly and in accordance with the manufacturing instructions.
• Documentation of in-process controls:
  
  • Contents: Documents containing the results of tests and analyses carried out at all stages of production — from testing raw materials to inspecting finished products.
  • Purpose: Ensuring that all tests have been carried out and that the products meet the defined specifications.
• Logbooks and forms:
  
  • Contents: Documents in which data on the operation of systems, storage conditions as well as other aspects of the production process are recorded.
  • Purpose: Keeping accurate records of all production processes for future checks and audits.
• Deviation logs and reports:
  
  • Contents: Documents in which any deviations from standard procedures or specifications are recorded.
  • Purpose: Determining the causes of deviations and preventing their recurrence through corrective measures.
• Documentation and reports on corrective and preventive action (CAPA):
  
  • Contents: These documents record the problems identified during production or quality control and the measures taken to rectify and prevent them in the future.
  • Purpose: Maintaining and improving the pharmaceutical quality system.

The purpose and importance of GMP documentation:

• Quality assurance: GMP documentation can be used to prove that the specified procedures and quality standards have been strictly adhered to at every stage of production.
• Traceability: The documentation allows all production and quality control steps to be traced, which is important for investigating possible deviations (translation into German: Abweichungen) and determining their causes.
• Compliance with regulations: Regulatory authorities require accurate and complete documentation to demonstrate compliance with GMP and other standards.
• Staff training and further education: SOPs (standard operating procedures) and other instructions help to train employees on how to carry out all work steps correctly.
• Risk minimization: Documented procedures and quality controls help to prevent errors, reduce the risk of non-compliance with GMP standards and improve production safety.

The proper maintenance and organization of GMP records is a crucial aspect of compliance with Good Manufacturing Practice standards and the production of high-quality drugs.

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