Establish a Systemic Quality Assurance
We Help You Establish Robust and Systematic Quality Assurance
Quality Assurance is mandated by law globally in order to maintain the safety and efficacy of medical devices and pharmaceuticals throughout their lifecycle. Properly established QA ensures that products meet stringent regulations and standards. Let our specialists and experts in quality assurance become a part of your quality team. We will walk you through establishing a systematic approach that ensures the highest medical device and pharmaceutical quality standards.
Why Quality Assurance
Every day, we utilize quality assurance in everything we do and don’t even know it. Humans are prone to make mistakes, so we are accustomed to checking and double-checking what we do. We check more frequently if it seems dangerous or important. For example, in driving, we check our mirrors frequently to check our surroundings or before we change lanes. We check our doors are locked when leaving the house. It doesn’t make us weak but human! We are not machines or robots.
We are designed and born to make mistakes. It makes us human, a perfect and beautiful one! However, mistakes are not permitted in manufacturing life-depending products. That’s why quality assurance and control (QA/QC) exist — double-checking everything we do!
Many managers and executives consider quality assurance complex and difficult to attain. As such, some managers overreact or overdo resources, causing confusion and difficulty gaining control. True, technological advancement has made quality assurance more technical and complex. But, the basics remain indifferent.
Quality assurance (QA) should be straightforward and use plain language that all employees understand.
For most manufacturing operations, quality assurance is as simple as 1, 2, 3 as below:
- Establish
- Validate
- Implement
Good Manufacturing Practices (GMP)*
It is called Good Manufacturing Practices (GMP) for a reason. As a manufacturer, you know the best about your products and how to manufacture them. You establish a robust system that works best for you, validate it to be optimal for your manufacturing process, and then train your quality units to implement them systematically. Your competitor’s QA/QC may not apply to you. As such, you will need applicable or suitable QA for your operations and products.
Variable Factors
There are many variable factors to consider when implementing Good Manufacturing Practices. For example, a simple checklist may work for small manufacturers when everyone has been performing the same routine for many years. However, the same manufacturing process may get more complex for larger manufacturers. Therefore, you cannot apply the same procedures to every facility, thus, Good Manufacturing Practices.
*Note that in some countries, a generic, government-issued GMP regulation applies to every manufacturer, so check with your country’s regulations.
Our Expertise in Quality Assurance
Mock FDA Inspection by Ex-FDA Investigator
Former FDA Inspectors
Our ex-FDA investigators have been in hundreds of small and large manufacturing plants. We have experienced most situations. We can solve any situation with you in a unique way that is tailored to your products and manufacturing operations.
Let’s come and do a mock inspection to assess the QA/QC situation.
Assisting an FDA Inspection
Controlling the situation is the key to your success in regulatory inspections or audits. Being familiar with the surroundings and process makes your quality unit staff less stressed; therefore, it is more manageable and can control the situation. This is where we come in. Consult with us to see what we can do for your quality unit.
We are here to help control your quality!
We invite you to contact us today to learn how we can join your quality assurance team. We’re here to help you ensure the highest standards of quality and safety for your medical devices and pharmaceuticals.