Maintenance is hot in all industries! GMP environments, such as the (Bio-) Pharmaceutical and High-End Food industry, require a high quality level for all processes that could affect the health of the patient. In the Oil, Gas & Chemicals industry the main focus is compliance with environmental and safety standards. Preventive maintenance is the key to maintaining the validated status of equipment and systems.
For the (Bio-) Pharmaceutical industry the principles of asset management fit in the life cycle approach to validation. Often there is a gap between C&Q and the total life cycle of the system and/or equipment. Asset Management gives the client the possibility to remain in a state of control during the (asset) life cycle of equipment and/or systems until retirement. Over the years Adryan Consultants has obtained extensive expertise in the field of maintenance management for the life sciences.
For the Oil, Gas & Chemicals industry it is important to provide visibility into assets and field equipment. Adryan Consultants helps oil, gas & chemicals companies and refineries to maximize return on assets. Process harmonization improves operational efficiency, while optimizing utilization of assets and reducing maintenance costs.
With our Asset Management service we can assist you in maintaining the full life cycle of systems, equipment and facilities, helping you to keep your facilities fit for purpose in a cost-effective way. This results in the following advantages:
- A clear structure is realized in the control of resources
- Enhancement of the maturity of asset management processes is achieved
- Process optimization is obtained
- Potential failures and maintenance requirements are identified by using predictive analytics and decision trees
- Cost reduction
- Improvement in corporate image.
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.
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
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.
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.
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.
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.
- 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.
Whether it is a greenfield project or a modification to an existing facility, Adryan Consultants has the engineering experience in various processes in the (Bio-) Pharmaceutical and High-End Food industry. We can deliver highly skilled professionals and/or a dedicated group of engineers who can provide engineering-related services such as design, supervision, execution, creation of drawings and specifications, process automation (from URS, FDS, SDS to implementation and qualification) and make recommendations to the client.
This includes clean rooms and air treatment (HVAC), fermentation processes, downstream processes, aseptic filling processes, CIP, SIP, freeze-drying, sterilization, water and steam treatment (WFI, purified water, clean steam), etc.
The projects in the Oil, Gas & Chemicals industries are maintained according to more demanding standards for safety, quality, health and environment. In this sector Adryan Consultants has experience with the design, construction and commissioning of typical equipment, such as dryers, evaporators, extruders, cyclones, filters, reactors and tanks.
All the projects we undertake are engineered and carried out in close cooperation with the customer and any third party suppliers. We start by evaluating the feasibility of a project, followed by design and construction of customized equipment. We ensure successful execution of the project or replacement and subsequent follow-up.
In a nutshell: We take on, organize and execute the entire job, start to finish, relieving the customer of all the issues of coordination, planning, supervision and hand-over.
Adryan Consultants has a highly skilled and experienced group of senior consultants who help our customers in various ways, for example:
- facilitating a high-level preliminary meeting for project start-ups
- performing gap analyses in order to qualify systems and asset management
- execution of pre-audits to get a facility IGZ, EMA and FDA ready, mainly focussing on quality systems, production, maintenance, packaging and logistics.
“The goal of technology transfer activities is to transfer product and process knowledge between development and manufacturing, and within or between manufacturing sites to achieve product realization. This knowledge forms the basis for the manufacturing process, control strategy, process validation approach, and ongoing continual improvement” (source: ICH Q10 (Pharmaceutical Quality System).
Adryan Consultants has successfully executed several Tech transfer projects. Typically we are hired to manage the overall project, including process transfer and manufacturing process scale-up.
In those cases we established a dedicated Process Team of bioprocess engineers who are responsible for the implementation process steps and for the execution of the pre-GMP and first GMP runs, with the support of QA, QC, Bioprocess Support and other departments related to production.
Technology Transfers occur between two parties (a Sending Site and a Receiving Site), within any transfer of the product life cycle, e.g.:
- laboratory to laboratory scale
- laboratory to development/pilot scale
- development to clinical manufacturing
- development to launch/commercial manufacturing
- drug substance to secondary manufacture
- lead manufacturer to third party manufacturer.
Our standard approach to Process Validation consists of the following stages:
- Stage 1 – Process Design: The commercial manufacturing process is defined during this stage based on knowledge gained through development and scale-up activities, according to the ICH Q8 (R2) Pharmaceutical Development.
- Stage 2 – Process Qualification: During this stage, the process design is evaluated to determine if the process is capable of reproducible commercial manufacturing.
- Stage 3 – Continued Process Verification: Ongoing assurance is gained during routine production that the process remains in a state of control.
Adryan Consultants can be your partner in achieving a successful technology transfer.
The need for organizations to hire an interim manager often comes unexpectedly. Examples are a sudden departure of a senior executive, planned absence in case of maternity leave or vacation, planned or unplanned dismissals, a sudden increase in workload, or an unexpected lack of appropriately skilled resources.
To help our customers with this often unexpected need Adryan Consultants actively maintains a worldwide network of competent and experienced general managers, plant managers, engineers and maintenance managers from different types of industries. For example, our interim managers are able to manage the complete transformation of manufacturing sites with severe quality compliance, safety, financial and on-time delivery problems.
Adryan Consultants can support your business with:
- Guidance of management and staff through new methods or processes
- Managing cultural change
- Mentoring/Team Development
- Quality management
- Program management.
Our project management approach is well-established and proven, with a significant track record in various industries and an impressive list of clients. Adryan Consultants ensures that all your projects are a success. Our project managers are working according to the latest project management methods (e.g. PRINCE2, IPMA, Lean Six Sigma). Our key traits are expertise, experience, independence and focus.
Adryan Consultants is an independent services group with no ties to other engineering companies, construction contractors or vendors. We can fully focus on making sure that projects comply with your objectives, interests and values. If required, our Project Managers can implement Project Management tools, e.g. Project Handbooks.
The following are typical projects in which Adryan Consultants is involved:
- Green and brown fields
- Relocation of a factory, warehouse or other premises
- Tech transfer
- Clean rooms, HVAC, utilities, process equipment.
Automation is more important than ever. Especially when using various control systems for utilities and processes. Some processes have been completely automated.
Adryan Consultants provides automation solutions for continuous or batch controlled processes, for any platform, ranging from systems based on PLCs with HMI/SCADA, to large DCS systems fully integrated with ERP through MES. We can take care of the process automation of your production equipment, such as bioreactors, filters, driers, centrifuges, fill and packaging lines, as well as your monitoring systems and utilities like BMS (including HVAC), WDI, HPW, CIP/SIP, including the integration of package units like washers and autoclaves.
Our Process Automation services include:
- Managing the entire lifecycle of systems, from design to decommissioning
- Defining the architecture of control systems
- Leading the technical analysis of quotations, ensuring its viability and the suitability of the proposed solution
- Leading the whole project lifecycle following the V-model, including FAT/SAT/IQ/OQ/PQ
- Defining, documenting and managing the programming standards according to ISA-88, ISA-95, cGAMP and 21 CFR Part 11
- Generating installation and configuration of manuals, both for equipment and software
- Defining, planning and managing training activities
- Defining and implementing test platforms.
Our main focus is to alleviate the concerns of our customers. Through the years Adryan Consultants has invested in several partnerships to create a network of engineers and consultants for the (Bio-) Pharmaceutical, High-End Food and Oil, Gas & Chemicals industries, which can support you in complex and difficult (often short-term) projects.
Typical requests can be:
- 3D-Piping Engineers/Designers
- Project Controllers
- Document Controllers
- Planners (Primavera, MS-Project etc.)
- Construction Manager
- Supply-chain specialists.