Setting up an Investigational Drug Pharmacy

Setting up effective, compliant investigational drug pharmacies means reviewing Food and Drug Administration (FDA)  requirements and applicable state boards of pharmacy.  Depending on the regulatory body reviewing the pharmacy, different parameters may need to be met. It is also important to have a well-developed process in place to ensure the accuracy and precision of drug products.  What Do State Boards Look for? The state board of pharmacy tends to be associated with the practice of pharmacy, which may be specific based on each state.  State boards deal with pharmacies at an individual level, and aim to ensure that facilities meet the requirements of the state board, and are appropriately registered and staffed. What Does the FDA Look for? In contrast to state boards, the FDA takes a more exhaustive approach.  The FDA generally looks for the compounding of marketed and unmarketed products which are able to meet the same accurate and precise measures every time.  In order to meet this standard, investigational pharmacies must focus on developing several processes. What Should Companies Focus on? Setting up a quality system In order for companies to make sure that their products are consistent, an effective quality system must first be put into place.  Quality control involves testing and inspecting product components to ensure that they meet approved specifications. All of the different specifications should be met before being put into the quality system so that quality is designed and manufactured into the product itself.  This process is often referred to as “quality by design.”   When setting up a quality system, one of the common setups that is used is the Deming or Plan-Do-Check-Act (PDCA) cycle.  This cycle allows companies to produce precise, accurate results every time. Corrective and preventative actions The FDA will typically look at seven major components of quality systems when measuring accuracy and precision.  They are mainly looking to make sure that there is a process in place to correct potential problems, and generate preventative actions. A corrective action involves addressing immediate problems and taking action to ensure that they are dealt with.  However, companies need to focus on more than this and take preventative action to ensure that future problems do not arise.  In order to take preventative action, companies must often perform a root cause analysis to evaluate why and how a given problem happened in the first place.   Production and process controls For production and process controls, the FDA will generally review process design, process qualification and continued process verification or validation.   Process design is involved at stage one, and refers to the commercial manufacturing process.  To meet FDA standards, companies must demonstrate that their manufacturing process is appropriately designed.  The manufacturing design is evaluated on the basis of how well it can reproduce commercially manufactured products.  Next, companies must demonstrate ongoing assurance during production to ensure that the process remains controlled. The process of validation requires companies to detect sources of variation in their products.  Further, companies must understand how this variation might impact the process and product ...