Quality Assurance & Quality Control

01 Chemical Receiving

• First, we inspect its container for damage and cleanliness
• Next, we verify all of its documentation and labeling
• We then take a sample of the chemical and send it to our Quality Control lab for testing

02 Quality Control (QC) Testing

Once a chemical goes through Receiving, lab analysts on our QC team:

• Verify that the chemical has been released by the FDA, and that the manufacturer and the chemical have been approved through our qualification program
• Perform a second verification of all the documentation and labeling
• Obtain the original certificate of analysis and check that the specifications and storage conditions of the API accord with manufacturer and/or compendial requirements
• Confirm the chemical’s identity through FTIR, compare the results with the latest USP compendial standard, and assess up to nine other factors
• Double-check every step and, if the chemical passes, approve it and release it for warehouse storage

03 Chemical Storage

After QC releases the chemical:

• The Warehouse Operations team verifies its labeling with the QC certification and place it under proper storage conditions
• Any chemicals that require refrigerated or freezer storage are warehoused in a strictly controlled, refrigerated environment at all times
• Our warehouses are all kept in check by an environmental monitoring system that records the temperature and humidity of the warehouses, QC lab and repackaging facilities
• A backup generator ensures that our operations areas always maintain optimal environmental conditions

04 Chemical Repackaging

To transfer the chemicals we receive from the manufacturer’s container to PCCA containers, we have a process designed from end to end to prevent cross-contamination and mislabeling

• Before we repackage a chemical, a chemical repacker again verifies the chemical labeling
• The repacker then repackages the chemical in a dedicated clean room under the appropriate environmental conditions to prevent chemical degradation
• After repackaging the chemical, the repacker cleans the entire room and then submits the documentation and a sample container of the repackaged chemical to Quality Assurance for review. A sample of every repackaged chemical undergoes Quality Assurance review

05 Quality Assurance (QA) Review:

After repackaging and before the chemical can be shipped out:

• A QA technician verifies the chemical’s labeling and all of its documentation, ensuring that it has been repackaged correctly
• They also verify that the chemical container is clean and in appropriate condition
• The QA technician then sends the chemical sample to QC for identity testing
• A QC lab analyst performs an identity test on the chemical to ensure that it is the correct one and matches all of the labeling and documentation
• A second QC analyst double-checks the testing results
• If the chemical has passed every check and test, QA releases it to the warehouse to be stored and shipped

06 Quarantine, Return, Disposal

• If at any point a chemical fails any of these checks or tests — from the moment it is first inspected in our receiving area to the moment it is released after repackaging and QA review — it is quarantined and either returned to the manufacturer or appropriately disposed of
• We reject up to 250 lots of chemicals every year

07 Warehouse Shipping

• When fulfilling orders, our Warehouse Operations team members use bar code scanners, ensuring that every item pulled for the purchase is the correct one

08 Shipping

• Team members select and pack all products under proper environmental conditions, with fulfillment areas for hazmat, non-hazmat, refrigerated and non-refrigerated items
• This system ensures that items are stored, pulled and shipped under appropriate conditions and results in over 99% accuracy in order fulfillment at PCCA