Compliance in GMP has received so many increases, innovations and new regulated segments that it can be difficult to keep up with today’s regulations. NORDIKA can guide you on your way to full service.
Nordika has been a leading international company in the development of new guidelines and best practices, and we are at the forefront with industry consulting to implement or improve practices such as:
Quality by Design – QbD
Quality based on the project. A systematic approach to development that begins with predefined objectives and emphasizes process control and product and process understanding, based on sound science and quality risk management.
NORDIKA uses the best engineering practices to guarantee the quality of its product from the beginning of the project
CAPA – Corrective and Preventive Action
The purpose of Corrective and Preventive Action methodology is to collect information, identify and investigate quality and product problems, and take appropriate preventive and / or corrective actions to prevent recurrence.
NORDIKA has solid knowledge and practices to assist you in the continuous improvement of your process.
NORDIKA has professionals qualified and recognized by the life sciences market, conducting IN-HOUSE training and / or through important institutions of education and knowledge dissemination.
Quality Risk Management
Quality risk management is a systematic process for assessing, controlling and communicating risks to the quality of the product throughout its life cycle.
Standard Guide for Specification, Design and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Equipment and Systems.
Emphasis on product quality and risk management associated with the process are part of the NORDIKA culture of developing and managing projects.
Systematic examination to ensure that the quality system complies with established requirements and determines their effectiveness.
NORDIKA conducts and conducts quality audits to assist your company in a constructive and preventive process to increase the effectiveness of the quality system.
An analysis that can be done for the quality system as a whole, or for different areas or activities. It aims to check if there is a gap or improvement point between the actual and required to meet any legislation, policy or standard. From the identified gap and / or improvement point it is possible to plan an action.
NORDIKA has a leading role in the life sciences industry, with recognized professionals in the market as references and influencers in their disciplines.
Commissioning and Qualification
At Nordika, we have the technology and knowledge to develop C & Q activities, using a risk-based approach and science, reducing testing and resource utilization efforts.
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Data integrity refers to the completeness, consistency and accuracy of the data. Complete, consistent and accurate data must be attributable, legible, contemporaneously recorded, originals or faithful, accurate copies (ALCOA)
Documented evidence demonstrating that cleaning procedures remove waste at predetermined acceptance levels, taking into account factors such as batch size, dosage, toxicological data, solubility and area of contact of the equipment with the product.Evidência documentada que demonstre que os procedimentos de limpeza removem resíduos a níveis pré-determinados de aceitação, levando em consideração fatores tais como tamanho do lote, dosagem, dados toxicológicos, solubilidade e área de contato do equipamento com o produto.
Validation of Computerized Systems
Documented evidence demonstrating that cleaning procedures remove waste at predetermined acceptance levels, taking into account factors such as batch size, dosage, toxicological data, solubility and area of contact of the equipment with the product.
Documented evidence that demonstrates with a high degree of security that a specific process will produce a product consistently, complying with pre-defined specifications and quality characteristics.