GMP documentation

optimally – with our support

  • Competent 360° support
  • Many years of experience
  • Global claim to leadership

Your advantages as a partner of Experts Institut

GMP documentation:
Thoroughly prepared, professionally organized, effectively executed

  • Competent support

    You can rely on consultants with many years of experience – for internal and external audits in the GMP and ISO areas.

  • Experienced - in all areas

    To ensure that your inspections and audits are successful and efficient, we are always at your side: from preparation to support and follow-up.

  • Supplier qualification

    If required, use the support of our experienced consultants for your company in supplier qualification at home and abroad – including in India and China.

  • National & international tätig

    Benefit worldwide from conscientious and careful support during audits and inspections in the GMP and ISO environment.

We are masters of documentation and use this to drive your company forward.

WE ARE

  • Uncomplicated and solution-oriented
  • Sustainable and empathetic
  • digital and agile
  • working where and for what we are needed

WE WILL

  • Building excellence and passing it on to our customers
  • Deliver high-level results
  • Achieving compliance and efficiency

WE DELIVER

  • personal integrity
  • Customized and feasible solutions
  • Meeting at eye level
Contact us

GMP documentation

Proper documentation is an essential part of GMP (Good Manufacturing Practice) compliance in the pharmaceutical industry. At Experts Institut, we offer comprehensive GMP documentation services to ensure that your documentation processes meet the highest quality and compliance standards. Our GMP documentation services include

1. documentation assessment: Our experts carry out a thorough assessment of your existing GMP documentation to ensure that it complies with current GMP requirements.

2. creation and updating: We support you in the creation and updating of GMP documents, including standard operating procedures (SOPs), protocols, reports and protocols for qualification and validation.

3. documentation strategies: We develop customized documentation strategies that are tailored to your specific requirements and processes.

4. training and training materials: We provide training and training materials to ensure that your employees understand and can effectively implement GMP documentation requirements.

5. compliance review: Our experts review your documentation for GMP compliance and support you in correcting deficiencies and implementing best practices.

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.

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.

Let’s work together!

Request

From raw materials to finished products, we ensure a seamless transition that helps to improve output quality, reduce costs and minimize waste. Let us be the driving force behind your non-stop production.

Get info

You will receive non-binding initial information and get in touch with your personal contact person.

Conversation

We will discuss your needs together in a personal meeting. You will then receive a concrete offer.

Optimal support

You benefit from our support in the area of audits and inspections.

Our motto

“We take responsibility and are there when we are needed”

<center>Christian<br /> Reinfelder</center>

Christian
Reinfelder

CEO
<center>Wolfgang<br />Rudloff</center>

Wolfgang
Rudloff

CEO
<center>Dietmar <br />Gross</center>

Dietmar
Gross

CEO
<center>Jessica <br />Siefert</center>

Jessica
Siefert

CEO
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