In the GMP environment, good documents help the employees to do their work and they are to prevent mistakes potentially resulting from oral communication. However, the reality we face in consulting and audits shows: this innate purpose of documentation is frequently not met. Instead, complicated documents, difficult to comprehend, or even impossible to act upon in reality, turn into real handicaps for employees from all GMP areas. We like to support You in the preparation, updating and optimizing of Your documents. Our goal is not only to provide You with documents which are plain, comprehensible and generally workable. We also want to make sure that those are customized and reflect Your particular processes and work flows optimally. Naturally, we are also happy to stay at Your side with assistance and advice all the way through implementation and training of SOPs, procedures and other documents.

Our services:

  • Review and re-wording of SOPs, manufacturing, quality control and test instructions, based on Your processes
  • Harmonization und optimizing of existing SOPs, manufacturing, quality control and test instructions
  • Preparation of validations master plans; master SOPs for validation and qualification
  • Compilation of equipment / instrument requirement specifications and User Requirement Specifications (URS) for GMP equipment qualification
  • Review and update of technical facility and equipment documentation (qualification and calibration)
  • Performance of risk analyses according ICHQ9
  • Concept preparation for monitoring tasks (monitoring of manufacturing and storage areas)
  • Preparation of GMP training concepts / plans
  • Preparation, review and update of Site Master Files
  • Data compilation, assessment and evaluation for PQRs / APRs