World-class Quality Management Systems

The entry ticket to doing business in the modern pharma industry is GxP compliance. If you want to do business with GxP companies, you must meet the same standards.

Complying with Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Delivery Practice (GDP) and the other GxP guidelines requires that companies not only have QMS Quality Management Systems (encompassing QC quality control and QA quality assurance) that are fit for purpose but world class to meet strict regulatory requirements.

Quality Challenges

Detailed regulatory challenges include keeping up with latest regulations from agencies like the FDA, EMA, MHRA, and WHO, and Implementing technical guidelines, such as ICH Q10 (Pharmaceutical Quality System) and data integrity principles. The latter have become almost a distinct discipline to make sure IT systems meet ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate + Complete, Consistent, Enduring, Available), prevent data falsification, missing records, or manipulation, managing electronic batch records (EBR) and computerized systems validation (CSV).

Most life science companies operate in a sterile world with contamination control, aseptic production challenges, and effective cleaning procedures as constant themes.

Other compliance issues include ensuring supplier and material quality, conducting supplier audits, ensuring process validation and batch-to-batch consistency, risk management and an effective system for CAPA corrective and preventative actions.

Quality management expertise

Improving quality management is a very human business. There is frequent need to address attitudes and organizational culture and the processes involved can be complex, demanding specific training.

Helping companies transform their quality management systems requires expertise and experience.

Qualitätswandel Dana Graupner GmbH is a consultancy organization that specializes in enabling companies in the pharma and life sciences sectors make process transformations that require re-engineered quality management systems.

Qualitätswandel is a ‘Quality Transformation’ specialist with a mission to help companies optimize their QMS Quality Management Systems at organizational and operational levels.

Leveraging Quality

Repeated successes in providing customized services highly tailored to individual businesses have made Qualitätswandel a first-choice service provider for life sciences organizations that are seeking to build QA systems from scratch or upgrade existing QMS for full regulatory compliance.

The company uses its in-depth knowledge of QMS and regulatory requirements in GMP and ISO standards to support companies in redeveloping their quality management processes. This not only achieves vital regulatory compliance but also plays a powerful role in enhancing products, processes, and brand value.

Quality Management Services

The wide range of Qualitätswandel services includes QMS development to GMP and ISO standards, process analysis, training and support for audits and inspections.

These consultancy services can be specifically tailored to the needs of individual pharmaceutical and medical product companies, as well as to clinical and pharmacy organisations.

Quality-related service offerings include:

• Quality Management Systems: Establishment and maintenance of QMS in accordance with ISO 9001, ISO 13485, 21 CFR Part 820, EU GMP and ICH Q10 guidelines.
• Regulatory compliance: Advising and supporting stakeholders in complying with regulatory requirements for pharmaceutical and medical devices, including admissions support and regulatory affairs management.
• Project management: including interim and personnel management in the areas of quality assurance and laboratory practice.
• Query Processing: including complaints, deviations, changes and CAPA corrective and preventative actions .
• Document support: Writing of technical documents to meet ISO and GMP standards, including translation, digitization, review and release of manufacturing documents.
• Risk assessment: according to ISO 14971 and ICH Q9.
• Method and Process Validation to comply with guidelines defined by CLSI, ICH Q2, EU-GMP Annex 15, USP <1225>, and 21 CFR Part 211.
• Computer Systems Validation in accordance with GAMP 5 guidelines.
• Audit services: Planning and execution of audits of suppliers and service providers as co- and lead auditor.
• Inspection services: Support during inspections by authorities and notified bodies, such as regional councils, TÜV, MDSAP, etc., as well as development and implementation of CAPA measures. This support can also extend to carrying out self-inspections.

Masters of detail

Quality management and quality control standards and guidelines are not only highly complex but are constantly shifting with technological change.

Qualitätswandel’s team of experienced and highly qualified consultants can provide detailed support and advice in all aspects of QC. These range from initial planning and scoping for establishing a company-wide QMS all the way through to final documentation and testing. On the way, consultants will work in close liaison with the client on such key details as development of quality control measures, risk management methodologies, definition of specifications, qualification of equipment and rooms and validation of processes and methods.

Qualitätswandel is also able to share its expertise in quality management and quality control training programs suitable for companies of all sizes.

Resources

Click on Qualitätswandel: Your External Partner for Quality Management Systems to learn more.
Click on Advice through Leadership to watch video
Click on Qualitätswandel Podcast for Spotify-hosted discussions on topics such as GxP, ISO, quality management and regulatory affairs.