Compliance & Validation

The main service for which Adryan Consultants has become known over the years is Compliance & Validation. It’s part of the wide range of services that Adryan Consultants can offer today.

Compliance & Validation is at the heart of any (Bio-) Pharmaceutical and High-End Food facility. Adryan Consultants offers a full range of Compliance & Validation services. For organizations with limited in-house expertise who need project support for Compliance & Validation issues, Adryan Consultants is a household name. We can ensure our clients that their regulatory and quality requirements are met at installation and during operation.

Commissioning & Qualification

What makes Adryan Consultants unique compared to other consultancy companies is that we understand the needs of our clients. The Life Sciences marketplace is diversified and globalized. Consequently, our consultants have to be able to come up with flexible solutions to help our clients in the validation of their systems and equipment.

Adryan Consultants adopts an integrated approach which ensures that our clients are covered for every validation phase, from URS to PQ/PV. That is why we base our Commissioning & Qualification approach on the client’s VMP. If not available we have the right people who are able to write one to suit the required purposes.

Adryan Consultants has extensive Commissioning & Qualification knowledge and experience in relation to the following systems:

  • Clean Utilities
  • Fill and Packaging Lines
  • Clean Rooms
  • Cold Rooms
  • Process Equipment
  • Process Control / Automation
  • HVAC.

Our consultants are able to help with writing and executing various types of protocols, such as FAT, SAT, DQ, IQ, OQ and PQ/PV. They can also write and assist in the preparation of supporting documents such as, for example, VPP and Risk Assessments.

Cleaning validation

In recent years we have seen many clients struggling to find the right approach to Cleaning validation. At Adryan Consultants we understand the necessity of providing documented evidence that cleaning methods are implemented within a facility in order to prevent potential carry-over of product (including intermediates and impurities), cleaning agents and extraneous material into the subsequent product. Our consultants follow the latest guidelines and standards.

CSV

Adryan Consultants offers a wide range of Computer System Validation (CSV) services in support of clients’ manufacturing, laboratory and enterprise systems. We provide a full understanding of (Bio-) Pharmaceutical and High-End Food business processes with regard to a practical risk-based approach to Computer System Validation. We ensure validation of systems in accordance with current guidelines and regulations, including all devices (hardware) and software for important functions in production processes. The consultants of Adryan Consultants have knowledge of all kinds of CSV platforms and activities, such as Siemens PLC, a Computer Lab Verifier in the lab, Excel sheets, Serialization, Building Management Systems, Aggregation solutions in packaging processes and verifying network and firewall upgrades.

Validation activities are planned and linked to the lifecycle of equipment, processes and products (ICH Q10). These activities are scheduled using Change Management. Validation planning is based on Risk Management (ICH Q9), a continuous activity throughout the lifecycle of systems and processes. The lifecycle of equipment, processes and products covers the full cycle from initial commissioning of a system to decommissioning, including all changes that may occur. Throughout the entire lifecycle it is necessary to maintain and guarantee the validated status of the system.

For system validation Adryan Consultants uses the latest GAMP guidelines as a starting point to define the required and delivered documentation per phase. The Validation Project Plan stipulates how the validation process should be set up, which systems and processes are to be validated, which qualification documents need to be delivered, which acceptance criteria apply and what the validation status is.

In addition to compliance knowledge and experience in the field of cGMP, CSV, GAMP, ICH, ISA 95 and ISO 13485, Adryan Consultants has extensive knowhow and experience in serialization and aggregation in packaging lines.

Our clients can rely on our knowledge and experience to support in validating their GMP systems. Validation activities include defining Validation Master Plans, IQ, OQ and PQ protocols, executing protocols and creating relevant reports. Moreover Adryan Consultants can support clients in defining User Requirements and the execution of FAT and SAT activities.

Quality Assurance

The QA consultants of Adryan Consultants are experts in the full range of Quality Assurance activities for the (Bio-) Pharmaceutical industry, be it in the role of QA Officer for production or QA departments, or in an Interim Management role. Their expertise is based on knowledge of FDA and European (EMA) legislation and regulations, as well as knowledge of various production processes and techniques including fermentation, aseptic processes and utilities. They have also gained many years of experience in the (Bio-)Pharmaceutical industry, working for multiple large and smaller companies in different roles.

Adryan Consultants offers Quality Assurance consultancy and Interim Management services for QA and production departments, for production of APIs (chemical and/or biological), Drug Products and for Packaging departments. These services include:

  • QA responsibility for greenfield projects or modifications related to production equipment, utilities, filling lines and packaging lines, according to cGMP, corporate company policies, etc.
  • Guidance and control with regard to the structure, maintenance and improvements for:
    • QMS – Quality Management Systems (QMS), Quality Manual
    • Other (automated) GxP systems and controls
    • Related training programs
  • Applying legislation and regulations in practical/pragmatic solutions.
  • Improvement and monitoring systems:
    • Change Control
    • Deviation/CAPA Management
    • Customer Complaints
  • Improvement of Business Processes related to Pharmaceutical/Medical Device production.
  • Support in setup, review and/or authorisation of Master QA documents.
  • Audits:
    • Internal system and/or performance audits
    • Vendor Qualification audits; Assessment of suppliers / CMOs / service providers, Quality Contracts
  • Support in Regulatory Affairs, Registration File assessments and changes and updates to Drug Master Files.