Authored By: Michael Sassano & Antonio Guedelha
The management of a Pharmaceutical Quality Control Laboratory is a complex task that contributes to monitoring and supporting every part of your product’s quality. Although the primary functional aspects of the laboratory are sampling, sample preparation, analysis, documentation and investigations on the product manufacturing, the Quality Control (QC) area also manages safety, the entry and exit of persons and materials, behavior, material stock, reactants, and standards.
Optimization of the laboratory can be accomplished by increasing the number of samples, meeting tight deadlines and delivering high-quality data on time. Optimization within the exact specification of Good Manufacturing Practices (GMP) rules and Good Laboratory Practices (GLP) is where experience and knowledge pay off.
Laboratory Stock Management
Timing and proper staffing are the target results of planning the various tasks to solve. For example, making a regular inventory of all reagents, chemicals, solvents, and standards should be simple for your company size. Depending on the number of different products and raw materials, this can be a significant number of items to control. When those numbers are high enough, they require additional staffing. To optimize this and delay additional staffing, the analyst can track the consumption of these materials through their computer system and then check the six month inventory to update their assumptions and get accurate values. Make sure to register the materials expiry dates — which we discussed in GMP #11 — in your SOPs.
Laboratory equipment layout
Well-designed workstations and equipment flow, as discussed in GMP #4: Lab Setup, will be the most crucial design choices early on and will set you up for an optimized lab flow. You may want to mark the position of the equipment, tools, and boxes on the tables or floor to keep all these extras in the proper stations. If it is unorganized, imagine wasting time searching for tools or small equipment when you could already be doing the analysis. Increasing your output also means adhering to proper GLP layouts with washing areas, High Performance Liquid Chromatography (HPLC) areas and weighing areas. Scale up your initial staff to ensure these structural issues are being well-run.
The 5S Methodology in the Laboratory
A powerful tool for laboratory optimization is the 5S methodology. The purpose of 5S is to reduce waste and increase efficiency. The 5S should be followed chronologically and cyclically:
- SORT: Separate what is unnecessary
- SET IN ORDER: Organize
- SHINE: Clean up and make it gleam
- STANDARDIZE: Implement Standard Operating Procedures
- SUSTAIN: Develop long-lasting habits
The 5S principles comply with GLP, but you must apply them correctly for successful implementation.
Laboratory Information Management System (LIMS) applications can be implemented to decrease workload and have robust data. Also, LIMS can be directly connected to analytical equipment to collect data. Bar code readers, used together with LIMS, can decrease the time needed to collect data and record it at the right place. Electronically connecting the lab to all the processes is a fun journey of computer implementation.
Before hiring, the manager needs to evaluate the competencies and work product of the analysts. A weekly plan of the QC Laboratory is a vital tool for organizing the team and for allocating resources.
In periods of peak demand, you may consider pulling some analysts to help technicians. For example, the stability studies analyst may help with the finished product analysis. This staffing method can ease peak demand. However, it’s important not to lose focus and ensure the timely delivery of all work. It’s imperative that analysts only perform analyses for what they are trained to do.
Training and Follow-up with Virtual Reality
Today Virtual Reality (VR) and Augment Reality (AR) developed for monitoring equipment is available from some analytical suppliers. These solutions significantly decrease errors and follow GLP best practices. See a few examples here:
CDC video: Lab Training VR
VR application video: Smart Glasses And The Lab of The Future
Robots and machine learning enable systemic development for automating some analytical tasks. Suppliers of analytical equipment are already introducing automation to their equipment. Tasks that can be automated greatly free up analysts and produce excellent results.
Setting Key Performance Indicators
Set aggressive but achievable KPI (Key Performance Indicators), like the quantity of analysis, number of not-delivered-in-time analyses, the number of analysis repetitions, technician throughput, and equipment output. Watching the monthly trends of these KPIs will improve targets for next year to be more accurate.
Be patient. These steps take years of optimization and budgeting for startups, so it’s excellent to plan your future as good decisions today are needed. Over time you will hopefully go through many upgrades and staff increases as your business becomes increasingly successful. A lab is a place that can slow down or speed up a facility, so monitor it well.