GxP Compliance

GxP Compliance

Most specifications for GxP compliance provide leeway for discretion and customized implementation.

Zamann Pharma Support focuses on identifying processes and the applicable regulations, developing customized solutions for the resulting tasks and integrating them into existing processes. We take into account the company’s size, culture, and risk strategy, for the best possible result: maximum benefits with minimal effort.

Zamann Pharma Support quickly and reliably gets to the heart of GxP Compliance for your company; we are not only a strategically‐conceptual consultant but also offer practical support.

Digital Transformation

Faster R&D processes as a result of online collaboration, direct market access thanks to patient engagement, exact proof of efficacy with the help of digital biomarkers, end‐to‐end logistics monitoring courtesy of blockchain… these are just a few of the infinite number of advantages and opportunities digital transformation and digitalization presents companies in the life sciences industry. Zamann Pharma Support is a global player in the field of digital transformation in the life science industry.

We run the biggest pharmaceutical B2B platform on the globe (Pharmatching.com), and we also work on new training methods using state-of-the art Virtual Reality technologies (Realification) for increased efficiency and automation in the on-boarding process of new employees.

There is a wealth of opportunities inherent to the rapidly developing technological solutions emerging on the market: digital biomarkers, wearables, big data, the Internet of Things, artificial intelligence, blockchain, augmented reality, 3D printing and infinitely more. Specialist departments are especially quick to jump aboard these trends, hoping to optimize their business. This often leads to conflict with technical, regulatory and organizational requirements or the company strategy as a whole. In any scenario, determining which technology is beneficial for the company or brings a competitive advantage is a sensible first step. Not everything new and interesting can be used profitably.

Digital Transformation
Serialization

Serialization

Serialization presents tremendous challenges - and equally tremendous opportunity.

Every pharmaceutical company - regardless of size, location, specialty and other differentiating factors - shares one common goal: ensuring that their medications are delivered safely to the people who need them. The recent rise in counterfeiting, diversion, and other illicit activity has put that mission at risk.

In response to growing drug integrity concerns, over 40 countries have introduced track and trace laws to help regulate product as it passes through the supply chain. In 2019, more than 75% of the world’s prescription medicines will be protected by legislation. While no two countries have passed the exact same legislated requirements, they all rely on the use of serial numbers, or serialization, as the core tracking component.

Serialization introduces tremendous complexity to your business. Each unit you produce must now be identified with unique data, which in turn must be stored and accounted for over many years. Complying with the new requirements means solving new challenges, including managing enormous volumes of data, integrating with CMOs, establishing connectivity with customers and trade partners for data exchange, managing serialization in the warehouse, validation of systems when changes occur, and more.

Many pharmaceutical companies who are currently implementing or initiating serialization projects are confronted with major obstacles. Zamann Pharma Support accompanies different customers through the process. We have compiled the typical pitfalls related to implementing serialization requirements and will show your company how to master these challenges.

Quality Management

The pharmaceutical industry must deliver products to the market with the utmost level of quality and safety. Anything less, these companies risk facing a recall, a loss of credibility and brand equity, as well as revenue.

In the US, for example, the Food and Drug Administration is cracking down on oversight and there is a raising need for initiatives and standards that will provide guidance to help enhance the scope of safety and quality within the pharmaceuticals industry. One of these standards is the International Conference on Harmonization Q10 model, which describes the elements of an effective pharmaceutical quality system. With a vision to develop “a harmonized pharmaceutical quality system applicable across the lifecycle of the product emphasizing an integrated approach to quality risk management and science”, ICH Q10 provides the framework for a truly effective pharmaceutical quality management system (QMS) and emphasizes continual improvement and management responsibility.

ICH Q10 is accepted by the European Union, Japan, and the US, which make up the three ICH regions. Regional good manufacturing practice requirements, International Organization for Standardization (ISO) QMS standards, and the ICH Q7 guideline – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients – set the foundation for ICH Q10. Zamann Pharma Support has been supporting large and medium‐sized companies in the pharmaceutical industry to solve quality and compliance challenges and have made sure that practicality and quality needs harmonize efficiently.

Quality Management

CSV (Computer System Validation)

Validation of computerized systems according to GxP Guidelines (CSV) has been a basic requirement in the life science industry for many years. However, as the complexity in the IT landscape and the degree of automation has increased significantly, the costs for compliance have risen disproportionately over the last few years and against a background of mounting pressure to reduce healthcare costs for the long term. Validating computerized systems (CSV) is crucial to patient safety. But how much does validation cost?

The solution

Nevertheless, the outlay for validating computerized systems can be reduced significantly for both suppliers and the life science industry, if the right strategy and implementation that is tailored to compliance requirements and your needs and processes are used. The HGP consultants will support you, not only as experts in GxP compliance and validation but also from the commercial aspect of cost-efficiency. This is what you can achieve:

  • GMP, GLP, GCP compliant IT systems and processes
  • The security of working in compliance with the FDA and EMA as well as according to current standards (21 CFR part 11, Annex 11, GAMP 5)
  • Sustainable reduction in outlay and costs for the validation
  • Security for internal and external audits
  • Validation strategy for implementing the risk-based approach
  • We will support you to determine the location of your current validation concept by auditing your organization’s
  • processes and tools from the following perspectives:
  • Outlay and costs, satisfying regulatory requirements, implementing the risk-based approach

Our consultancy package includes:

  • CSV audit: auditing the validation status
  • CSV strategy:producing and implementing a validation strategy subject to the risk-based approach (GAMP 5)
  • CSV implementation: implementing validation projects for IT systems, laboratory systems, and automation systems
  • CSV Support and Project Management: We will support you during the Life Cycle Management with project management activities and/or document creation.

Acting as a software developer in the life science industry, CSV is a focus and core competency of Zamann Pharma Support.

CSV (Computer System Validation)

Validation of computerized systems according to GxP Guidelines (CSV) has been a basic requirement in the life science industry for many years. However, as the complexity in the IT landscape and the degree of automation has increased significantly, the costs for compliance have risen disproportionately over the last few years and against a background of mounting pressure to reduce healthcare costs for the long term. Validating computerized systems (CSV) is crucial to patient safety. But how much does validation cost?

The solution

Nevertheless, the outlay for validating computerized systems can be reduced significantly for both suppliers and the life science industry, if the right strategy and implementation that is tailored to compliance requirements and your needs and processes are used. The HGP consultants will support you, not only as experts in GxP compliance and validation but also from the commercial aspect of cost-efficiency. This is what you can achieve:

  • GMP, GLP, GCP compliant IT systems and processes
  • The security of working in compliance with the FDA and EMA as well as according to current standards (21 CFR part 11, Annex 11, GAMP 5)
  • Sustainable reduction in outlay and costs for the validation
  • Security for internal and external audits
  • Validation strategy for implementing the risk-based approach
  • We will support you to determine the location of your current validation concept by auditing your organization’s
  • processes and tools from the following perspectives:
  • Outlay and costs, satisfying regulatory requirements, implementing the risk-based approach

Our consultancy package includes:

CSV audit:auditing the validation status

CSV strategy: producing and implementing a validation strategy subject to the risk-based approach (GAMP 5)

CSV implementation: implementing validation projects for IT systems, laboratory systems, and automation systems

CSV Support and Project Management: We will support you during the Life Cycle Management with project management activities and/or document creation.

Acting as a software developer in the life science industry, CSV is a focus and core competency of Zamann Pharma Support.

Data Integrity

Data integrity must be firmly anchored in the culture of a company. It should be communicated and experienced across departments and hierarchies. The demand for data integrity has been long-standing: the paper-based manufacturing documentation has already been subject to review, and that has not changed since electronic data acquisition came about.

What is new about the topic, is the increasing complexity of state-of-the-art IT solutions and automation infrastructure! How can one be sure with the enormous amount of data from a wide range of organizations, technologies, and processes that all is “ALCOA+”? During an audit, it is irrelevant whether data integrity violations are due to deliberate falsification, a mistake, or system failure. The application of the right tools and measures ensures the accuracy between the data and its references – from acquisition, storage, and all the way to the destruction of the data.

Key to data integrity is the introduction and implementation of a holistic information management strategy. The starting point is the identification of data and data flow. On that basis, sustainable processes for the secure handling of data in all divisions of the company are implemented. Zamann Pharma Support specializes in the pharmaceutical industry, and is familiar with all regulatory requirements regarding data integrity (FDA, EMA, MHRA).

Data Integrity