Welcome to AlfaNordic A/S - Excellence in GMP

QA / QC

EU GMP, FDA, EMA, ISO, ICH samt GAMP og ISPE

AlfaNordic’s QA consultants

The quality work has always been a core area within Life Science (pharmaceutical industry, Biotech and Medical Devise) and the requirements have been perceived as being on the rise during the last many years. It is therefore extremely important for the manufacturers that their quality departments work to an optimum within the balance between thoroughness and flexibility, where the foundation is always the legislature in effect at all times as well as cGMP.

QA employees also find themselves in a context with constant changes as optimisations/LEAN are often part of the agenda. At the same time, the rule and regulations in effect are optimised towards heightened quality with consequently increased requirements for the documentation. The GMP rules are continuously under revision and one of the constant change initiatives is that the requirements for risk assessments are continuously increased for new as well as existing products and processes. The results are inherent requirements for and expectations of a proper ”root cause analysis”.

The area of QC and QC Support are seeing comparable changes, and at the same time, the analysis equipment becomes more effective and sophisticated, and validation of analysis methods and equipment consequently make bigger demands on the technical competencies – including knowledge of IT/Automation.

We can help you keep one step ahead

We work for many different customers in this exciting field and have in-depth knowledge of regulatory requirements and other initiatives that the industry is subjected to. We are constantly working on improving our competencies in order to keep abreast of the expectations that both authorities and the internal ”stakeholders” place on QA/QC.

  • Compliance EMA, QMS / QRM, FDA GMP & ISO

  • QA – Product, Production and Documentation Approval

  • Production Support – Batch Documentation, Non-Conformities, CAPA

  • Audits – Supplier and Internal Audits

  • QP – Qualified Person(s)

  • QA of validation documents

  • Production Chemists – Various Support Functions

  • SOP – Writing and Training SOPs

  • cGMP Training

We deliver high-end documented solutions

Our QA/QC area delivers high-end services that are in compliance with Eudralex vol 4, FDA201, 211 & 820 and ISO 13485 including all guidelines. Our QPs can furthermore act as delegate QPs and Quality Reviewers within all aspects of QA. In QC, we work with analysis methods, method development and equipment qualification and method validation. And finally, we handle OOS/OOT and documentation in general.

Why us?

The QA consultant department under AlfaNordic provides services to the Life Science, that is the pharmaceutical, biotechnological and the medical device industry. We feel that we are fully equipped to compete with companies many times our size for the following reasons:

  • We combine solid experience with quality assignments with in-depth pharmaceutical and biotechnological expertise, developed during many years of service to the industry.
  • We hire skilled people who know how to keep several balls in the air at the same time. Quality, speed and execution are key words for ensuring effective work routines, regardless of whether the role is as a participant in interdisciplinary teams or as an advisor to top management.
  • We promote professional development and strive to make talented people even better.

Controlled growth and increasing efficiency are often key words for a company’s success and profitability. These goals are just as often the company’s highest priorities, but can be reduced or disappear via daily interruptions by inadequate and risky processes in QMS, development and production.

As a partner, AlfaNordic will be the best within this field. We assess the quality-related risks connected with processes and products, and we provide consulting services all the way out through the value chain to the patient and internal customers in your company.

Client Advantage

Our employees all possess significant knowledge and experience within the Life Science industry – both from the part of the customer and as consultants. Our consultants are all able to enter into a close cooperation with our customers as if they were part of the team in the company. This is true regardless of whether the assignment is for a short or longer period of time and whether it is in Denmark or abroad.

As a consulting house, we take an active part in spotting new trends in the industry and thus breaking down barriers and developing and creating sustainable solutions for our customers.

Our Track Record

Our consultants have headed quality projects at some of the biggest companies in Denmark. This work has brought us to Asia, South and North America and to several countries in Europe.

Customers like Bavarian Nordic, Biogen Idec, Novo Nordisk, Leo Pharma and Statens Serum Institut are just some of the companies that our consultants visit. We hope that we can also pay you a visit.

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.

QP

We work under Eudralex vol 4 and we can support you with Senior Quality Consultants who are able to work both as a Qualified Persons (QP), as a Delegate QP and as a QP assistant. Our consultants can furthermore act as delegate QPs and Quality Reviewers in all parts of the Supply Chain.

Training

We conduct many different kinds of GMP training courses – all the way from basic GMP training of production employees to company adapted courses with subjects like Qualification/Validation, Good Distribution Practice and Good Documentation Practice where the starting point is the company’s own procedures and documentation.

QA

We work with all processes within the quality area and execute all forms of reviews and approvals. We have in-depth knowledge of production processes, qualification/validation and pertaining documents. We prepare APR/QPR documentation.

Audits

We conduct GMP & GDP audits with emphasis on the inspectors’ focus areas. We conduct/plan internal audits as well as supplier audits of both raw material and equipment suppliers. We have conducted audits in countries like: Denmark, Germany, Ireland, England, France, India and China. We also have experience with audits of CMOs and Mock audits.

Production support

We have in-depth experience with supporting production departments with tasks that secure a future QA approval – that is, we draw up non-conformities, we review all types of documents, prepare SOPs and make sure that qualifications/validations are performed within the correct quality.

QC

We are experienced in performing method validations/optimisations of chemical and physical methods with all aspects from setting up acceptance criteria, drawing up protocols, execution and reporting. We have in-depth knowledge of all elements from procurement of analysis equipment to qualification of this equipment (URS, IQ, OQ, PQ) – execution as well as documentation. Our consultants can support you via OOS, ILI, troubleshooting and CAPA and moreover make sure that QC is in GMP compliance at all times.

Contact our quality team

Do you want to know more. Do you have competency inquiry or request. Or maybe you want to present us with a challenge? You are always welcome to contact one our area managers. They are ready to answer your questions.

Paul Orlien
QA / QC

T: +45 5356 7700

Christian Ilsøe
Co-owner, Board Member & Senior Consultant

T: +45 5152 9030

Preben Lind Hansen
Business Development

T: +45 6146 2340