No "GMP certificate" without the right documents
GMP (Good Manufacturing Practice) is often translated figuratively as "Give more paper”. In fact GMP compliant documentation is very extensive. There are instructional documents that describe and specify how something is done in a GMP-compliant manner, and there are reporting documents that prove that work has been done in a GMP-compliant manner. The GMP documentation covers the entire pharmaceutical quality management system up to records.
Do you want to check your documentation system for GMP compliance or set up a GMP-compliant system? Then you are at the right address! We are a GMP service provider with many years of experience and can support you in manifold ways. In addition to our team of experienced GMP consultants, we also have a team of GMP documentation experts. Thus, we offer professional and efficient documentation support.
- We review your documentation trough a gap analysis. The results are summarized in a report listing the measures required to bring your documentation system into GMP compliance. We can also support you in implementing these measures: either in an accompanying consulting or by providing documentation support.
- We support you in setting up your pharmaceutical quality management system (PQS). In cooperation with you, we set up a system that meets your needs in terms of scope and complexity. We can also take over the entire documentation service.
Do you already have a pharmaceutical quality management system but need support in individual subject areas - in terms of content or in terms of documentation - we are ready and prepare:
- Master documents : Site Master File (SMF), Validation Master Plan (VMP), Hygiene Master Plan.
- Qualification documentation: concept, instructions, templates, plans and reports
- We set up your qualification system together with you.
- Devices and equipment
- We support you in the preparation of qualification documents according to your existing system: from the User Requirement Specification (URS) to the release of the qualified equipment, facilities or rooms.
- We execute technical risk analyses.
- Validation documentation: concept, instructions, templates, plans and reports
- We set up your validation system together with you:
- Process validation
- Computer system validation (CSV)
- Validation of analytical methods
- Cleaning validation
- We support you in preparing validation documents according to your existing system.
- We execute process risk analyses.
- Manufacturing documentation: specifications, batch documentation
- We prepare development reports,that map your pharmaceutical development in cooperation with you.
- We describe your processes with all necessary specifications, instructions (manufacturing instructions, operating instructions, hygiene regulations, etc.) and forms for documentation (e.g. batch record).
- Documentation in quality control: specifications, test instructions and test reports, release certificates (Certificate of Analysis (CoA), Certificate of Conformity (CoC))
- We describe your methods with all necessary specifications, instructions (test instructions, operating instructions, hygiene regulations, etc.) and forms for documentation (e.g. test protocol, CoA).
- As well as other SOPs, forms and lists
- We support you to describe and implement the document control system that is suitable for you. There are paper-based, electronic or combined document management systems.
- We offer training services: Not only in the contents of a pharmaceutical quality management system, but also in documentation management and Good Documentation Practice.
- We support you in Good Documentation Practice, i.e. in the way your employees document their work: In cooperation with you, we create a concept including instructions for Good Documentation Practice, train your employees and ensure that your forms are suitable and compliant.
- We create concepts to ensure data integrity and support you in their implementation.
All documentation service packages can be requested individually or in combination. We offer fixed prices for defined overall packages and charge upon proof for continuous project support. Our documentation experts will be glad to advise you in advance of the project, but will of course also support you in the ongoing process.
Trust us! Because we know how to efficiently implement the demanding requirements of extensive GMP documentation!