Welcome to AlfaNordic A/S - Excellence in GMP

Validation

Experienced and professional experts

AlfaNordic’s Validation consultants

At AlfaNordic, quality is paramount and we understand the importance of the qualification and validation work which in the final analysis is about patient safety.

Our work is based on a risk-based approach to qualification/validation with a systematic assessment of the task, so focus is aimed at the aspects of the validation that might have a critical impact on the product. You as a customer will, to a higher degree, be able to argue for the product safety in your discussions with the authorities.

We have in-depth knowledge of the pharmaceutical and biotechnological industry and meet our customers where they are. Our customers will meet experienced and professional validation consultants who are able to step in directly as a worthy sounding board.

We can help with our broad experience

Qualification and validation take up a lot of space and require extended efforts in the pharmaceutical production, it is therefore natural that this discipline constitutes a larger part of AlfaNordic’s many competencies. We offer our customers support within qualification and validation of facilities, equipment, processes (API, Aseptic, Packing), cleaning validation and IT/automation. We perform tasks for our customers with short notice within projects of a shorter or longer duration. Our skilled employees offer assistance with or performs validation management (Project Management), planning, design, practical execution of validations and assessment of existing validations. We can lead, perform reviews and perform Quality Assurance (also in the role of QA) or we ourselves can prepare the necessary documentation during the product’s entire lifecycle, or during part of it.

  • GAP analyses

  • FMECA risk assessments and QRM

  • Validation Master Plan / Validation Plan (VMP/VPL)

  • Operational and Process Performance Qualification (OQ/PPQ)

  • Standard Operating procedures (SOP)

  • Trend documentation (Periodic reviews)

  • Change Request

  • Requirement Specifications / Functional Specifications (URS/FS)

  • Requirement Traceability Matrix (RTM)

  • Design and Installation Qualification (DQ/IQ)

  • Process Verification (PPQ/PV)

  • Review of validation documentation (also in the role as QA)

  • Training of employees

  • Non-Conformities

We offer validation

Validation and qualification are performed on facilities, equipment, processes (API, aseptic, packing, cleaning validation and IT / Aut.

We assist with PQ and PV as well as Cleaning Validation. We can lead, perform reviews and perform Quality Assurance or we ourselves can prepare the necessary documentation.

Why us?

We are a specialised group of consultants at AlfaNordic, providing services to the pharmaceutical and biotechnological industry. One of our strengths is to perform validation work at different levels in a disciplined manner. Use us for what we are good at, that is, providing practical help and experience to the validation work.

We can provide the experience that can prevent you from making mistakes, and if the damage has already been done, we can help solve it.

Client Advantage

AlfaNordic’s consultants possess the experience and competencies needed for the task. We have a wide segment of consultants with in-depth experience within DQ, IQ, OQ, PQ, PV and Cleaning Validation.

Our Track Record

  • Qualification and validation of a semi-automatic robot for aseptic production (Rigshospitalet)
  • Validation of packing line including serialisation (Novo Nordisk)
  • Autoclave validation (Xellia)

Our sales and services process

The course of events for assignments normally goes through the following process.

1. Competency needs

The competency needs for the specified task are identified together with the customer. A sales meeting may be held. Please contact AlfaNordic sales department or an area manager.

2. Proposal and review

AlfaNordic draws up a proposal, identifies time frames and provides CVs for the task. The proposal is forwarded to the customer, followed by a review and a discussion. A meeting may be scheduled for further discussions of the proposal.

3. Contract

AlfaNordic sends the contract to the customer for approval. The contract covers economy, named consultants and time consumption, as well as start and end dates.

4. Start of task

AlfaNordic’s consultants start working on the task at the agreed date and time.

5. Continuous follow-up

AlfaNordic follows up on the consultants and continuously hold status meetings with the customer as well as with the consultants.

6. Completion of task and customer evaluation

The task is completed within the agreed time and economy. AlfaNordic follows up with a customer evaluation form and a concluding dialogue with the customer.

Requirement Traceability Matrix (RTM)

As an essential part of a successful validation, it is necessary to secure traceability of URS requirements to the validation documentation – an RTM is drawn up for this and this RTM is thus the backbone of the coming validation.

Operational and Process Performance Qualification (OQ/PPQ)

A controlled method for demonstrating fulfilment of functional requirements and performance requirements. The method will ensure that requirements from the URS via the RTM are tested according to a protocol with several test plans that are subsequently consolidated in a report. This will form the basis for the final approval of a piece of equipment.

Validation Master Plan / Validation Plan (VMP/VPL)

In order to secure a smooth validation, a validation plan must be drawn up for the project, – that is, a description of the roles and responsibilities of the different ”stakeholders” throughout the project.

Process Verification (PPQ/PV)

A controlled method for demonstrating fulfilment of process and product requirements. The method will ensure that the requirements from the URS via the RTM are tested according to a protocol with several test plans that are subsequently consolidated in a report. This will form the basis for the final approval of a process.

Design and Installation Qualification (DQ/IQ)

The purpose of the DQ is to make sure that the chosen solutions fulfil the specified requirements. The process entails involvement by supplier/QA and the user. The Installation Qualification is a controlled method with a protocol, test plans a report that demonstrate fulfilment of the installation requirements.

Our customer evaluations

from previous tasks

Average customer evaluations for completed tasks. Grades applied according to a scale of 1 to 5:

  1. Unacceptable
  2. Less acceptable
  3. Acceptable
  4. Good
  5. Very good
GMP training in 2015
4.27
Projects in 2015
4.14
Risk Assessment in 2014
4.10

Contact our validation team

Would you like to know more? Do you have a competency request? Or maybe you have a challenge for us? You are always welcome to contact one of our area managers. They are ready to answer your questions.

Mai-Britt Olafsson
Validation

T: +45 5353 4378

Henrik Linnemann
Co-owner, Board Member & Senior Consultant

T: +45 2811 0091

Preben Lind Hansen
Business Development

T: +45 6146 2340