QA / QC

EU GMP, FDA, ISO, ICH as well as GAMP, ISPE and EMA

QA-consultants in AlfaNordic

Quality work has always been a core area of Life Science (pharmaceutical industry, biotech & medical devices) and the requirements have been constantly increasing over the years. Therefore, it is imperative for manufacturers that their quality departments function optimally in the balance between thoroughness and flexibility, and that the basis is always the applicable legislation and cGMP. QA employees are also in a context where there is constant change, as optimizations / LEAN are often part of the agenda. At the same time, the existing sets of rules are changed towards increased quality consciousness and risk evaluation - with optimized requirements for documentation as a consequence. The GMP rules are constantly under review, and one of the pervasive change measures is that there are increased requirements for risk assessments for new as well as existing products and processes. As a consequence, further systematic analyzes of the "root cause" are demanded / expected as well as a more risk-based approach on qualification and validation requirements. Similar changes are seen in conjunction with the analysis equipment being both more efficient and more sophisticated. This effect both the validation of the analysis method and of the equipment and the increased demands also requires further professional competences - including knowledge about IT / Automation and dataintegrity.

AlfaNordic risk management

Implement risk management so that you have an overview to do things right
- first time
Be able to make the best business decisions in mitigating risks in your organization.
Learn more about risk management

AlfaNordic Audit

Know your cGMP gaps
Take AlfaNordics advice
Be able to make the best business decisions in mitigating risks in your organization.
Learn more about Audit

We can help you stay ahead

We work for many different customers in this exciting field and have in-depth knowledge of government requirements and other initiatives that the industry is undergoing. We are constantly working to improve our competences to stay ahead of the expectations for QA / QC set by both external stakeholders, such as authorities, and internal stakeholders.

We provide high-end proven solutions

AlfaNordic QA / QC delivers high-end services that are compliant with Eudralex Vol. 4, FDA 210 & 211, 21 CFR 820, 21 CFR part 11 and ISO 13485 including all guidelines. Our QPs can also act as QP delegates and quality auditors in all aspects of QA. In QC, we work with analysis methods, method development as well as equipment qualification and method validation. Finally, we handle ”Out-Of-Spec”/ “Out-Of-Trend” (OOS / OOT) and corresponding documentation. 

In addition to this, we have strong consultancy expertise in food and comedy law.

The following are examples of our expertise within QA/QC:

QP

We work based on Eudralex vol 4 and we can support with experienced quality consultants who can work both as Qualified Persons (QP), as QP delegates and as QP assistants. We have consultants with extensive experience within releases in all parts of the supply chain.

QA

We work with all processes in the field of quality and carry out all kinds of review and approval. We have in-depth knowledge of both production processes as well as qualification / validation and related documents. We prepare Annual product review /Quality product review (APR / QPR) as well.

QA - fødevarer og kosttilskud

We offer comprehensive consultancy services in food and dietary supplements. 

  • Classification
  • Product Evaluation
  • Product labeling and information
  • Evaluation of promotional materials
  • Authority contact
  • Quality Management Systems 

QA - Cosmetics

We offer comprehensive consultancy services in cosmetics 

  • Quality management systems according to ISO22716
  • Product Evaluation
  • Product labeling and information
  • Evaluation of promotional materials
  • Preparation of dossiers regarding cosmetic inclusive safety reports, cf. applicable EU rules
  • Office Contact

Production support

We have extensive experience supporting production departments with tasks that ensure a later QA approval - ie. we handle and investigate deviations/non-conformities, review all types of documents, write standard operating procedures (SOPs) and ensure that qualifications / validations are performed to compliance.

Teaching

We carry out many different types of quality training (GMP=Good Manufacturing Practices) - from basic GMP training of production staff to company customized courses with topics such as Qualification / Validation, Good Distribution Practice (GDP) and Good Documentation Practice (GDocP), based on the company's own procedures and documentation.

Audit

We conduct GMP and GDP audits, based on inspectors' focus areas. We conduct / schedule both internal audits and audits of suppliers of raw material and equipment. We have conducted audits in Denmark, Germany, Ireland, England, France, India and China, among others. We also have experience with audits of CMOs (Contract Manufacturing Organizations) as well as mock inspections.

QC

We have experience in conducting analysis method validations and optimizations of chemical and physical analysis methods with all aspects from setting up acceptance criteria, protocol writing, tests and reporting. We have in-depth knowledge of all elements from purchasing analysis equipment to qualifying the same (URS, IQ, OQ, PQ) - both execution and documentation. Our consultants can provide support in connection with ”Out-Of-Spec” (OOS), “Interim Laboratory Investigation” (ILI), troubleshooting and CAPA and can also ensure that QC is in compliance with GMP at all times.

Why us?

We are a specialized consulting department within AlfaNordic, serving the pharmaceutical and biotechnology industry. We feel able to compete with companies with much bigger size for the following reasons:

Controlled growth and increasing efficiency are often the key to a company's success and profitability. These goals are just as often the company's main priorities, but can be reduced or disappear by daily disruptions of inadequate and risky processes in administration and production. As a partner, AlfaNordic will be the best within the field. We evaluate the strategic risk and provide organisational advice to the entire value chain of your company.

Our sales and delivery process

1. Competency needs

The competence requirement for the desired task is described together with the customer. Possibly a sales meeting will be held. Contact AlfaNordic Sales or a Function Manager.

2. Proposal and review

AlfaNordic prepares presentations, time requirements and CVs for the task, as well as sends the presentation to the customer and goes through it. A possible meeting for further discussion of the presentation.

3. Contract

AlfaNordic submits a contract for approval by the customer. The contract includes financial information, named consultants and time consumption, as well as start and end dates.

4. Start of task

AlfaNordic's consultants start the task at the agreed time.

5. Continuous follow-up

AlfaNordic follows up on the consultants and holds regular status meetings with both the client and the consultants.

6. Completion of task and customer evalution

The task ends at the agreed time and with the agreed price. AlfaNordic follows up with a customer evaluation form and a final dialogue with the customer.

Contact our QA/QC team

Ole Markersen
Director, Medical Device, Quality Assurance, Regulatory Affairs & Pharmacovigilance
+45 3144 7511
Email
Rasmus Kriegel
Partner, Sales
+45 3144 7515
Email
en_US
da_DK en_US

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