QC Planning and Scheduling in Pharmaceutical and Biotechnology Laboratories
Pharmaceutical and Biotechnology manufacturers continue to operate in a highly competitive environment within the changes required by new regulations and other compliance mandates. The Quality Control (QC) Laboratories plays a vital role in pharmaceutical production for both in process and finished product testing. Especially in QC Laboratories or R & D labs, quality planning and scheduling are major challenges for many of the organizations because they have high diversified drug products that are to be tested with a huge number of analysts and instruments.
As a result, to improve QC Lab operations, Scientists/Analysts/Quality Planners/managers are finding a way to improve in processes, utilization of resources or work centers, reduce lead times while increasing reliability and speed up the authorizations required for compliance, for both production and batch release.
A good Quality Control Planning describes how an organization will achieve its quality goals that specify the quality assurance and control activities to be performed in a day to day lab operations. The Analysts from different sections has to analyze different types of incoming samples like Finished Goods (FG), In-Process, Stability Samples, Raw Materials, and Environmental Samples, etc. in their Quality Control Labs for testing purpose.
Some of the challenges of manual planning and scheduling
- Samples received in QC labs are registered manually in books, paper records or excel sheets based on specifications for which they need to be tested or analyzed.
- Difficult to manage and maintain scheduler or planner for allocation of resources within multiple sections in a Lab where there is a high volume of samples or tests to be planned and scheduled to perform the actions.
- Analyzing the different samples like Finished Goods (FG), Raw Materials, In-Process, Stability Samples and Environmental Samples based on demand, priority wise is very difficult to manage and create proper scheduling based on the availability of Equipment Instruments and Analysts availability, etc.
- Due to unavailability of planners and analysts, leading to rescheduling the day or weekly work plan. In some scenarios like re-test, re-samples taking place within workflows of various department.
- Allocation of resources like an instrument for analyses, identifying the analyst who has to perform such actions is a major challenge to track down
- Uneven workloads on skilled and unskilled technicians, where the process getting a down break and unsatisfactory planning leads to high operating costs
- The large volume of data like sample results, estimated duration, the actual duration of the test or task execution are maintained on different templates of spreadsheets and also in paper records.
- Slipping of schedule like adding a resource can bring the schedule back to its actual or original target date or time or if any other adjustments like adding or deleting the test cycles, resources and changing the dates or time that impacts the delivery timelines
- There is no proper planning for some of the samples that are to be tested based on demand, priorities.
- Generating the reports of analyses from different instruments like HPLC and where analysts have to report delays are taking place during the process such as delays in equipment’s or instruments, calibration issues and waiting for analysts or technicians during the group of test samples
- All the Lab Technicians/ Analysts/ Planner/Scheduler are focusing on manual planning instead of task execution which results in additional work hours incurring high operating costs
- One of the major challenges is managing the equipment/instruments and analyst during the OOS. Most of the times, analysts are using the non-calibrated instruments for analysis because unable to identify the calibrated and non-calibrated list of instruments from a group of instruments.
For example, without using QC planning and scheduling in pharmaceutical Laboratories QC teams may not estimate the proper test planning, execution time, completion of task within days or weeks, etc. and so on.
Due to manual administrative works like data entry, calculations, sample specifications lead to incorrect output results, prone to human errors as well as decreases the efficiency of a lab.
In order to avoid the complexity of scheduling, an ideal solution is required to minimize the time spent by the scientists/analysts or any supervisors and provide the flexibility to change schedules based on demand and optimize the lab efficiency, performance in terms of test cycle times and on-time deliveries.
AmpleLogic “QC Planning and Scheduling” Software
AmpleLogic QC Planning & Scheduling Software is a web-based solution designed specifically for Quality Control Lab and R&D Laboratories. It helps you to plan and schedule your resources, track the laboratory activities involved in your lab and generate user configurable reports to have a quick decision making to analyze.
AmpleLogic QC Planning and Scheduling Solution can automatically calculate the efficiency of each analyst based on the completed samples or actual tests. This feature enables both analysts and management to track their individual performance and efficiency with the reasons of the delay, time consumption which gives the insight to identify about the analysts whether they are required an additional training as well as the challenging tests in the labs
AmpleLogic Solution will allow you to connect from anywhere any time with compliant features to ensure data integrity, regulatory compliance, traceability, and audit readiness.
This QC Planning & Scheduling Software will comply with FDA 21 CFR Part 11, EU Annexure, MHRA, Good Manufacturing Practice (GMP), Standard Operating Procedures (SOP’s) and Batch Record Instructions, ISO and other regulatory requirements.
Features of Quality Control Planning & Scheduling Solution
- Create and set a paperless lab scheduling and planning taking into account resource availability and time deadlines.
- Full visibility on your lab performance, resource utilization, instrument usage and availability for allocation is visible in the daily, weekly and monthly schedule with easily customizable reports
- Provides accurate resource needs based on your unique requirements and accordingly create or deliver a laboratory QC Plan with a single click
- For Stability and Finished Goods (FG) Samples, a separate test schedule can be created based on urgency or if it is to be completed within a day
- Auto-generate email triggers, escalations and communicate the scheduled activities to your analysts.
- Automatic Planning and Scheduling delivers daily, weekly or monthly schedules based on QC Analysts and Instruments availability. The System can automatically block the resources until the time of OOS, Root Cause (RC), has been completed across the various departments in a laboratory by different analysts
- Allows you to create customized reports and charts as well as you can import or export your data to an excel spreadsheet for detailed analysis
- Able to track reports of each employee or resource is assigned to the optimal amount of task, real-time data gives the overview of shortfall or excess in resources which will enable you to quickly identify any gaps in the last minute
- This QC Planning Software shows each task, the analyst is assigned to complete it, the actual duration of the work and also estimated duration for a test
- Auto schedule the samples or test activities based on analyst’s availability, qualification, experience level, due date, critical path tests, batch size, and priority, etc.
- Supports regulatory compliance by providing a complete audit trail, electronic signatures, email alerts, and field-level security, etc.
- This software can indicate different color coding to the analyst regarding the schedules like lateness, being late and criticality, etc.
- Gives QC planners instant real-time visibility of each team availability against the current work, unavailability, etc.
- Based on product grouping we can also group different samples to minimize the overall test time
- Auto Generate Reports on Weekly/Monthly basis on and Monitor Key Performance Indicators (KPI’s) based on Samples, completion of time and employee performance
Benefits of QC Planning & Scheduling Solution
- This application is simple and easy to use with a drag and drop feature, allowing your team to quickly plan, schedule and reschedule your daily lab activities and resource
- Manage, view and edit schedules from anywhere at any time and give employees to instantly access from any web-based browsers
- Integrate with multiple data sources like ERP, Legacy Systems or with any existing systems
- Configure the solution to your specific or unique requirements when it comes to creating, planning and scheduling the activities
- Single Dashboard provides you to see and take appropriate action against all your job activities
- Avoid unnecessary meetings between the departments and endless e-mails, monitor achievements on a weekly, monthly, quarterly or on a yearly basis
- Helps organizations to manage and optimize their resource allocations, increase productivity, save time, reduce operational costs and increase efficiency
- Eliminate Paper records in a controlled way that increases lab efficiency, reduce errors. And consolidate your data into a single repository, saving your time lost looking for information.
- Enhance communication and visibility for all departments and functions, hence it can reduce the emails, phone calls about the status of samples
AmpleLogic QC Scheduling Software will support the head of departments, managers, and supervisors in allocating the various tests required to release the different samples to various analysts, based on critical, due date work-load and other parameters