Quality and Compliance

The Quality Assurance team at BioCentriq has overall responsibility for ensuring that all functions – from manufacturing to quality control, to supply chain management and facilities and engineering – are compliant with both regulatory and cGMP guidelines and standards. The goal is to ensure that we produce a safe and effective product and that all activities are conducted in a controlled and transparent manner with the appropriate supporting documentation. Below is a list of some of the activities the Quality Assurance team will be responsible for as it relates to your program.

Manage BioCentriq’s Quality Management System (QMS) which is MasterControl 

Conduct all batch release activities,  including the review of batch records, deviations, in-process data, EM data, QC release testing and other quality systems as applicable  

Approve all release documentation including COT, COA and product labels 

Provide on-site support and guidance for manufacturing teams  

Release raw materials and components 

Provide key input and manage documentation of change controls, GMP investigations, OOS incidents and CAPAs 

Lead all partner and vendor audits 

Manage continuous improvement programs 

Ensure appropriate levels of training are conducted and training records available 

Maintain BioCentriq’s Site Master File 

Establish quality agreements with partners 

Oversee all vendor qualification activities 

Support client specific regulatory submissions and interactions as appropriate 

A key aspect of being able to release your drug product for use in clinical trials is being able to demonstrate that you’ve met minimum safety standards with compendial studies such as sterility, mycoplasma, and endotoxin testing. Additional non-compendial analytics specific to the specifications of your product may also need to be tested. BioCentriq has the right Quality Control (QC) experts, laboratories, equipment, methods, and vendor relationships in place to make sure you can supply the data you need to be able to demonstrate product safety and adherence to drug product specifications. The QC team will work with you and the rest of the BioCentriq team to do the following:

Qualify the methods used to test your product to ensure suitability 

Evaluate which testing can be performed in-house at BioCentriq and which should be outsourced 

Establish data that can be used to support your IND submission as needed 

Confirm sampling plans required to support your in-process and release testing 

Execute tests and publish results required to support your product release 

Conduct in-process and release testing using methods such as qPCR, rapid micro methods, flow cytometry, ELISA, and automated cell counting  

Test and provide confirmation of results to release incoming and prepared or manufacturing materials  

Leverage their network of approved and qualified CROs as needed  

BioCentriq has deployed MasterControl as its digital quality management solution, which provides us with an electronic system for controlled documentation, management of training records, automation of training tasks, reporting to demonstrate compliance, execution of change controls, reporting to support audits, and much more.

Throughout the course of our work with you, the BioCentriq team will help ensure that you understand and have considered the FDA guidelines for the CMC portion of your IND submission(s) and created, verified, and submitted everything you need to demonstrate that you have met the requirements. This includes making sure you can demonstrate the identification, quality, purity, and strength of your drug as well as communicate how any safety issues might be addressed. Any differences between the drug product planned for use in clinical studies and that used in animal toxicology studies will also have to be described.

If needed, BioCentriq can also supply additional regulatory advisory services to guide you in the development of your submissions and applications, support your interactions with the regulatory agency and its representatives, or walk you through the impact of specific guidelines and requirements. This includes making sure you can demonstrate the identification, quality, purity, and strength of your drug as well as communicate how any safety issues might be addressed. Any differences between the drug product planned for use in clinical studies and that used in animal toxicology studies will also have to be described.