AN GROUP A/S
cGMP Compliance and Validation Services
Medical Devices Pharmaceuticals
Contents
• About us .......................................................................................................................
4
• Services ........................................................................................................................ • Quality Management Systems (QMS).................................................................................
5
• Validation ...................................................................................................................... • Equipment Validation ......................................................................................................
7
6 8
• Process Validation...........................................................................................................
9 • Cleaning Validation ......................................................................................................... 10 • Revalidation ................................................................................................................... 11 • Validation Strategy.......................................................................................................... 12 • Software Validation......................................................................................................... 13 • Audit ............................................................................................................................ 14 • Mock Inspection ............................................................................................................. 15 • Inspection Readiness ...................................................................................................... 16 • Risk Management ........................................................................................................... 17 • Corrective and Preventive Action (CAPA)............................................................................ 18 • Regulatory Affairs........................................................................................................... 19 • Training ........................................................................................................................ 20 • Serialization and UDI ...................................................................................................... 21 • Quality Support.............................................................................................................. 22 3
About us
For more than four decades, AN GROUP A/S has cooperated closely with top Life Science companies to provide solutions, from large scale applications to smaller technical solutions. "We ensure a flexible and solution-orientated partnership – as specialists, solution developers and project managers.“
About us At AN GROUP A/S, we leverage our extensive knowledge of clients' core business to create holistic and sustainable solutions. As advisors, project managers, specialists and developers, we play an active role in the change management and development process. …From idea to implementation.
4
Services
AN GROUP A/S provides comprehensive, hands-on GMP Quality Compliance services to our clients in the pharmaceutical, medical device and biotechnology industries.
Our GMP consulting services are characterized by: · · · · · · ·
Clear and responsive prioritization Competence and efficiency Rapid mobilization for GMP client assistance Extensive experience Superior and wide-ranging networks Unparalleled dedication to GMP & Compliance A convenient single point of contact
What our clients say "Our clients perceive AN GROUP A/S as flexible, agile, innovative and trustworthy, taking great pride in our ability to develop and implement projects on time, on budget, and to a high quality standard."
5
QMS
From design, manufacturing and distribution to post-marketing activities, a well-established Quality Management System(QMS) is key to all stakeholders, especially in today's Life Sciences Industry.
We work with our clients to develop or improve their existing QMS to better meet their needs.
We ensure regulatory compliance and QMS efficiency. E.g. we provide: · Implementation of QMS according to ISO 13485 and FDA 21 CFR 820 · Preparation of Standard Operating Procedures (SOPs).
Medical Devices Pharmaceuticals
6
Validation
Validation is the process of establishing documentary evidence demonstrating that a procedure, process or activity is carried out in testing. Production maintains the required level of compliance at all stages. Because a wide variety of procedures, processes and activities require validation, this field is broad and requires expert knowledge of both overview and individual process.
We work with our clients to establish necessary documentation. Our approach is adapted to client needs, regulatory expectations and product risk. We offer to manage all phases of validation projects, beginning with strategic planning until the process is successful. We take responsibility for establishing and optimizing validation procedures. Our consultants possess profound knowledge of different processes and validations, to the benefit of our clients.
Medical Devices Pharmaceuticals 7
Equipment Validation
In precision instruments, lab equipment or specialized machinery, even minor inaccuracies can cause problems and lead to inaccurate or incomplete results. Equipment validation ensures your product consistently performs within a given range. Most clients look for certification from Quality Management Systems, like ISO, before they even consider buying a product; inaccurate equipment validation can threaten your adherence to industry norms as well as your certifications and compliances.
We work together with clients, from the initial specification phase to procurement, to ensure that new equipment will fulfill their expectations. We establish necessary equipment validation documentation adapted to the client's needs, regulatory expectations and product risk. We offer to handle equipment validation projects, from their strategic planning throughout commissioning and validation. 8
Medical Devices Pharmaceuticals
Process Validation
Process Validation demonstrates that the whole process is in compliance at all stages of production. It veriďŹ es that the entire system and process is controlled, and that the expected product is consistently and reliably produced. Process Validation is not only a requirement of Medical Device, Drug and Pharmaceutical regulating agencies such as the US FDA and their GxPguidelines, it is also a unique opportunity to gain valuable knowledge about process, production and product. Process Validation establishes documentary evidence demonstrating that the all procedures, processes and activities are successfully controlled and compliant at all stages.
We build Process Validation systems. We work together with clients to build the knowledge necessary to achieve successful process validation. Our approach is adapted to the client's needs, regulatory expectations, and product risk.
Medical Devices Pharmaceuticals 9
Cleaning Validation
Cleaning validation is the art of establishing documentary evidence demonstrating that product residues from equipment are eliminated successfully in order to prevent cross-contamination. Cleaning validation is a very strictly regulated area, demanding a high level of knowledge and expertise with the speciďŹ c techniques used to acquire the necessary evidence.
We work together with our clients by sharing the knowledge critical to carrying out a cleaning validation process that successfully meets the client's needs and regulatory expectations.
Medical Devices Pharmaceuticals 10
Revalidation
Revalidation or periodical validation is carried out for a variety of reasons, such as time lapse, repair or relocation. For certain types of high-risk process equipment, it is a mandatory requirement of Medical Device, Drug and Pharmaceutical regulating agencies such as the US FDA and their GxPguidelines that patient safety is ensured on a long-term basis. Sterilization and aseptic processes are high-risk, and thus should be validated periodically. If routine revalidations required, it is typically conducted using a concurrent validation approach. The testing is executed on a preset frequency, using a standardized pre-approved protocol or standard operating procedure.
We work together with clients to establish the necessary documentation and adapt standardized procedures to client needs and regulatory expectations.
Medical Devices Pharmaceuticals 11
Validation Strategy
Extensive validation is required at installation and at regular intervals throughout a system's life span, to ensure compliance with regulatory demands. Validation is a complex, time-consuming procedure involving different qualifications of equipment used in development and manufacturing. Therefore, it is critical to define a well-organized approach to system validation projects. An effective validation strategy is necessary to develop, verify, install and maintain systems. This creates a truly competitive advantage in a changing, global marketplace.
We work together with clients to analyze, optimize and establish necessary validation strategies adapted to the client's needs and to regulations.
Medical Devices Pharmaceuticals 12
Software Validation
Projects within the Life Sciences industry are characterized by extensive regulatory requirements. These must be applied from the initial phase and throughout the entire life cycle of the production facilities to ensure that the products manufactured by the client always fulfill the approved specifications. Increased levels of automation and computer-controlled analysis mean higher throughput and less room for human error by operators.
We offer our clients validation services for existing as well as new computer systems and automation equipment. We assist in determining the validation scope, planning and qualification management based on a categorization of hardware/software in accordance with GAMP and GxP criticality, as well as system assessments in compliance with 21 CFR Part 11. We carry out all validation activities in projects, including the preparation of test plans, test forms, execution of tests, deviation and change control, as well as the related documentation and reporting. Software validation is a key competence at AN GROUP A/S.
Medical Devices Pharmaceuticals 13
Audit
Whether a client needs to complete a Mock inspection, an internal or supplier audit, we are able to assist. We offer value-added QMS audits, where the focus is ensuring that our clients and their suppliers are in compliance. Our audits are performed by a team of global experienced and international certified auditors. Audits are guided by best practices, as well as experience and recent industry trends. We manage the entire process, from making all arrangements, completing and reporting to final follow-up. We perform audits in: · ISO 9001: Quality Management Systems · ISO 13485: Medical Device – Quality Management System · ISO 17025: General requirements for the competence of testing and calibration laboratories · 21 CFR 820: Quality System Regulation / Medical Device / Good Manufacturing Practises
Medical Devices Pharmaceuticals
14
Mock Inspection
The purpose of a Mock Inspection is to determine whether an organization is prepared for a full Stage II audit in compliance with standards specified by a third-part Certified Body (CB) or regulatory requirements by, e.g., FDA. The Mock Inspection aids your company in preparing for an actual formal audit process. It ensures that your organization continuously complies with specified policies, procedures, and external requirements in meeting company goals and objectives, and is an opportunity to identify and implement necessary improvements to the management system.
We can perform a Mock FDA Inspection of your operations to determine compliance to the FDA QSR (Quality System Regulation)/cGMP (Current Good Manufacturing Practices). Mock Inspection are performed in compliance with FDA auditing standards by former US FDA field investigators, via our partner (Supaso International).
Medical Devices Pharmaceuticals 15
Inspection Readiness
GMP Inspection Readiness is essential, whether preparing for an EU or FDA Inspection, or a third-part or other partner audit. The process includes: · Performing assessment of Inspection Readiness at site · Preparing GMP Inspection Readiness Program · Assisting client organization in launching GMP Inspection Readiness Program · Providing training for SMEs so they are ready at all times to interact with regulatory inspectors · Performing Mock, GMP, GCP or GLP inspections · Reporting deficiencies and recommending actions to address them · Working with client organization to implement necessary changes
AN GROUP A/S's partner (Supaso International) employs a number of former FDA regulators with the experience and expertise to provide services supporting the organization in introducing a program for GMP Inspection Readiness and preparing for FDA Inspections and QSR, GLP, GCP or CAPA inspections. 16
Medical Devices Pharmaceuticals
Risk Management
We have experience integrating quality Risk Management into quality systems, so our clients benefit from quality risk management plans that comply with regulations. We specialize in process and software risk management. We use the risk assessment as input to define the extent and scope of validations. We support our clients by facilitating the risk assessment process, risk assessment training, root cause analysis training and SOP writing. Keywords: · ISO 14971: Medical Device – Application of risk management to medical devices · ICH Q9: Quality Risk Management
Medical Devices Pharmaceuticals 17
CAPA
The FDA's Corrective Action Preventive Action (CAPA) system requires that problems are investigated and prevented in future products. Including CAPA in a Quality Management System (QMS) is crucial for FDA compliance. Planning and implementing CAPA requires time and resources. Many companies are either inexperienced with CAPA or lack adequate resources for implementation.
We assess clients' current QMS systems and processes, make recommendations, and provide direction while helping to implement an effective CAPA process. As part of our CAPA Consulting services we can: · Determine client's individual needs and where CAPA process can be of benefit · Evaluate the resources currently available for developing and implementing CAPA · Mentor and coach client teams to expedite CAPA implementation
Medical Devices Pharmaceuticals
18
Regulatory Affairs
We offer our clients the following Regulatory Affairs services: · Classify devices and provide appropriate conformity assessment routes · Perform toxicological evaluation on medical devices, IVDs, in-vitro fertilization devices (IVF) and OTC drugs · Prepare and update technical file · Device Classification · Prepare and submit applications for FDA and maintain FDA submissions · Provide strategies for toxicological testing · Coordination with laboratory test agencies, international regulatory agencies (competent authorities) and notified bodies · Plan, prepare, and implement regulatory strategies on international product registration and submission of product dossiers
Medical Devices Pharmaceuticals 19
Training
Our consultants have experience performing a range of training options for clients. Training courses are based on client needs. The trainings we offer include: · · · · · · · ·
Process validation Software Validation Risk Management Supplier Control Statistical Process Control Good Documentation Practices Good Testing Practices Warehouse and Distribution
"Let us know your training needs. We can tailor our courses to your particular goals. We have access to several facilitators, all former FDA Officers with extensive experience in various program areas."
Medical Devices Pharmaceuticals 20
Serialization and UDI
Pharmaceutical Serialization is the tracking and tracing of a prescription drug's path through the supply chain, from manufacturing to dispensing. The Unique Device Identification (UDI) System is intended to assign a unique identifier to all medical devices. The UDI is expected to improve patient safety (in part by helping to identify counterfeit products, and improving the ability of staff to distinguish between devices that are similar in appearance but serve different functions). Both Serialization and UDI present opportunities to improve efficiency, safety and patient care. This is generally accomplished through automated, electronic means, and is legally required in many countries. It involves such company practices as recording, authenticating, maintaining and sharing accurate records of items prior to dispatching. We are able to provide both the compliance service and IT infrastructure to support Serializationas well as UDI. We plan, implement and lead Serialization/UDI projects for medical devices, device combination products, and stand-alone software. This includes executing the changes necessaryfor compliance with UDI regulations, as well as incorporating UDI processes into quality management and production operations.
Medical Devices Pharmaceuticals 21
Quality Support
We oer our clients a depth of experience in dierent areas. Our clients receive support in their quality organization, whether they need special expertise or assistance in implementation. Our consultants have diverse experience and are able to work independently and in teams. Their focus is on providing value and ensuring goals are reached. We can take responsibility for large or small projects by providing project management and the right team or person for the task. Our commitment to delivering valuable knowledge and expertise to our clients is unparalleled.
Medical Devices Pharmaceuticals 22
Contact information
AN GROUP A/S Mejeribakken 8 DK-3540 Lynge Denmark
AN GROUP A/S Øster Fælledvej 11 DK-9400 Nørresundby Denmark
AN GROUP A/S Hareskovvej 19 DK-4400 Kalundborg Denmark
AN GROUP A/S Hovedgaden 54 DK-8220 Brabrand Denmark
AN Group A/S Nørre Sundby
AN Group A/S Brabrand
AN Group A/S Lynge
AN Group A/S Brabrand
Serbien
Kosovo
Company: +45 48 25 10 00 / +45 31 42 00 49 E-mail: gmp@angroup.dk Web: www.angroup.dk
www. ReklameService.dk · 5951 6615
AN GROUP Balkan Novi Sad Novosadskog Sajma, Str. No. 3 Serbia
AN Group A/S Kalundborg