By Mat Khaloobagheri
Navigating the ever-changing regulatory environment is tedious, expensive, and time consuming. Regulators want to know you're doing all you can to ensure the quality, safety, and efficiency of the products you sell. Stockholders and management want to know you're preserving the organization's precious resources by trimming excess spend from your budget. This challenge represents the proverbial "rock and a hard place." However, being in compliance is more affordable than being out of compliance.
Acetake Group offers a wide variety of validation services that meet FDA, ICH, and many European standards. Although our primary focus is on that of the pharmaceutical and biologics industries, we also perform many required studies for food and beverage, cosmetic, industrial, and medical device companies.
Since our customers are regulated by either GMP, ASTM, GLP, or the Code of Federal Regulations, we understand that one off-the-shelf protocol template would not be enough to satisfy each of our customer's diverse needs. For this reason, we customize our protocol packages to meet the specific quality system of every customer that we service. The quality department is allowed to review our documents before we arrive on site to ensure that there are no gaps, and all regulations are met.
In addition to customization of protocols, we also understand the need for flexible scheduling and service options to minimize cost and disruptions. We often work around production schedules on a second shift to maximize our customer's operational times, diminishing interruptions of the day-to-day business. Our services can be protocol generation only, execution of customer protocols, or the full suite of protocol generation and execution.
No matter what service is requested, a technical validation representative will assist our customers in determining the best scope of work for each job and provide a detailed quote that clearly establishes the scope of the job. There is no opportunity too large or too small for our team. We are focused on a partnership with our customers to enhance their experience. Our expertise is vast, including expertise for small jobs with a single piece of equipment or large-scale remediation project with hundreds of instruments.
We verify that the equipment does what the manufacturer says it will do. To prove that a piece of equipment is performing consistently, we perform IOPQ testing. These initials stand for:
Installation Qualification (IQ): This verifies that the unit is installed properly. We will check voltage, proper leveling, etc. We do not install the equipment as part of the IQ.
Operational Qualification (OQ): This is when we test all of the features of a unit such as the control panel, any on and off switches, alarms and 24-hour mapping for temperature units. For non-temperature units we test other features like rotation for centrifuges, pH units for pH meters, and weighing accuracies for balances.
Performance Qualification (PQ): This is what we test to ensure that the unit operates as the customer requires it to work. This is customer specific and will require our team working with yours to define the scope of work.