GMP documentation: We are your partner for the review & creation of GMP documents!

Master documents

• Site Master File (SMF)
• Quality Management Handbook (QMH)
• Qualification Master Plan (QMP)
• Validation Master Plan (VMP)
• Hygiene Master Plan
• Pharmacovigilance Master Plan

Qualification documentation

• Concept, instructions, templates, plans and reports
• We build your qualification system together with you for:
  • Rooms and clean rooms
  • Monitoring systems
  • Devices and equipment
  • Supply and media systems
     
• We support you in the preparation of qualification documents and in the implementation of the qualification, with our own templates or according to your existing system. From the specification (User Requirement Specification, URS) to the technical risk analysis to the release of the qualified premises, facilities, or equipment, we are your partner.

Validation documentation

• Concept, instructions, templates, plans and reports
• We set up your validation system in cooperation with you for:
  • Process validation
  • Computer system validation (CSV)
  • Analytical method validation (AMV)
  • Cleaning validation (CV)
• We support you in the preparation of validation documents, the execution of validation including formal risk analyses, using our own templates or according to your existing system.

Manufacturing documentation

• Specifications, batch documentation, Certificate of Conformity
• In consultation with you, we create development reports that map your pharmaceutical development.
• We describe your processes with all necessary specifications, instructions (manufacturing instructions, operating instructions, hygiene regulations, etc.) and form sheets for documentation (e.g., batch record).

Documentation in quality control

• Specifications, test instructions and test protocols, Certificates of Analysis (CoA)
• We describe your methods with all necessary specifications, instructions (test instructions, operating instructions, hygiene regulations, etc.) and form sheets for documentation (e.g., test protocol, CoA).
• This also applies to other SOPs, form sheets and lists.
• We support you to procure and implement the right document management system, paper-based, electronic, or combined.
• We offer training: Not only regarding the contents of a pharmaceutical quality management system, but also in document management and Good Documentation Practice.
• We support your personnel in Good Documentation Practice, i.e., in the way they need to document their work: Together with you, we create a concept including the instructions for Good Documentation Practice, train your employees and ensure that your forms are suitable.
• We create concepts with you to ensure data integrity and support you in their implementation.