QUALITY MANAGEMENT
AdvaCare’s quality management system includes all aspects of quality relating to facilities, products, and service.
The AdvaCare philosophy on quality management focuses on establishing quality, productivity, and a competitive position. Our management are evaluated monthly on the following principals:
– Customer Focus
– Leadership
– Process Approach
– Continual Improvement
– Factual Decision Making Process
Customer Focus
Understanding current and future customer needs is paramount to our success. It is our policy to meet customer requirements and exceed the expectations of all customers.
Leadership
Our management establishes a system of accountability in which every employee assumes a leadership role, resulting in every member of every department becoming fully involved in achieving quality objectives.
Process Approach
Every task, activity, and resource must follow established procedures to ensure uniformity and accountability in everything we do.
Continual Improvement
One of our permanent quality objectives is the continual improvement of overall performance, which is implemented and evaluated on an individual level. Every employee is expected to also contribute to the improvement of the company as a whole.
Factual Decision Making Processes
All decisions made by management are based on data analysis and information. Decisions to be made without such required information must get approval of our Board.
QUALITY ASSURANCE
Production
Good Manufacturing Practice (GMP) is the part of quality assurance which ensures that products are consistently produced and controlled to the appropriate quality standards.
GMP is aimed at diminishing the risks of cross contamination/mix-ups and false labeling.
Above all, AdvaCare is most concerned with protecting the end user and avoiding risk due to inadequate safety, quality or efficacy.
Distribution
Any comprehensive system of quality assurance must be founded on a reliable system of controlling the products quality.
All of our manufacturing operations are designed to exceed the accepted norms of GMP.
Our customer’s distribution channels and supply chains follow quality assurance as well in order to ensure our end users are getting quality medicines.
Inspections
The objective of inspecting pharmaceutical manufacturing facilities is either to enforce GMP compliance or to provide authorization for the manufacture and importation.
AdvaCare frequently conducts both internal and third-party inspections to monitor the quality of manufacturing facilities and pharmaceutical products from the point of manufacture to delivery to the recipient, as a means of eliminating the hazard posed by the infiltration of counterfeit drugs.
Quality Control
The term quality control refers to the sum of all procedures undertaken to ensure the identity and purity of a particular pharmaceutical product.
AdvaCare’s procedures range from the performance of simple chemical experiments (thin layer chromatography, infrared spectroscopy, etc.), to more complicated requirements of pharmacopoeial monographs.
Activities extend to the area of quality control laboratories (good laboratory management practices, models, etc.) for Certificate of Analysis and lists of laboratory equipment.
- Do you want to know more about our standards?
Do you want to know more
about our standards?
QUALITY CONTROL
AdvaCare’s approach to quality control emphasizes three aspects:
- Elements such as controls, job management, defined and well managed processes, performance and integrity criteria, and the identification of records;
- Competence such as knowledge, skills, experience, and qualifications;
- Soft elements such as personnel integrity, confidence, company culture, motivation, teamwork, and quality working relationships.
AdvaCare’s quality control system emphasizes the rigorous testing of products to uncover defects, and reporting to management who make the decision to allow or deny the release, whereas quality assurance attempts to improve and stabilize production, and associated processes, to avoid issues that lead to defects.