Documentation evaluation:
Our experts carry out a thorough assessment of your existing GMP documentation. This includes protocols, reports, standard operating procedures (SOPs), guidelines and all other documents relevant to your pharmaceutical production. During this assessment, we check whether your documentation complies with current GMP requirements. We identify possible gaps, inconsistencies or violations and assess how well the documentation documents the manufacturing process.
Creation and updating:
We support you in creating and updating your GMP documentation. This includes the development of new documents required to ensure compliance with GMP guidelines and the updating of existing documents to ensure they meet current standards. This may include the creation of new SOPs, validation protocols, qualification reports and other relevant documents.
Documentation strategies:
Our experts develop customized documentation strategies that are tailored to the specific requirements and processes of your company. This includes defining responsibilities, processes and schedules for creating, updating and managing your GMP documentation. Our goal is to ensure that your documentation processes are efficient and effective while meeting compliance and quality control requirements.
Training and training materials:
We offer training courses and training materials to ensure that your employees are familiar with the GMP documentation requirements and can implement them effectively. This can include training in the creation and maintenance of documents as well as training in the correct use of SOPs and other documents in your manufacturing process. Well-trained employees are crucial for ensuring GMP compliance.
Compliance review:
Our experts check your GMP documentation for compliance and support you in rectifying deficiencies and implementing best practices. We check that your documentation contains all the required elements, including data integrity, traceability and data security. If deficiencies are identified, we develop action plans to rectify these deficiencies and bring the documentation up to the desired standard.
Our GMP documentation services aim to ensure that your pharmaceutical documentation processes meet the highest quality and compliance standards to ensure the safety and quality of your products.
