Laboratory Control System Operations in a GMP Environment. David M. Bliesner

the expendables budget derived from existing data and takes into consideration projected changes in manufacturing volume and its impact on testing workloads? 2.3.5 Does the laboratory have a clearly defined and functional capital expenditure budgeting process? Capital expenditures include purchasing pieces of equipment and instrumentation such as HPLCs, GCs, balances, etc. 2.3.6 Is the capital budget derived from existing data and take into consideration new product introductions, changes in manufacturing workloads, etc.? The age of equipment should also be a consideration. Equipment and often the software used to run it need to be replaced from time-to-time. Aging equipment can lead to unnecessary laboratory investigations, which are time-consuming and often not value-added. 2.3.7 Is there a change control system in place to ensure that the purchasing department cannot “swap out” supplies or vendors without involving the laboratory purchasing personnel to prevent inappropriate substitution of materials or equipment? For example, instances have been observed where the purchasing department, in an effort to save money, has switched vendors who make syringes, which are used to remove samples from dissolution baths. The result was extraneous peaks in the chromatography because the less expensive syringes included a lubricant in the syringe barrel, which was not present in the original validated method syringes. 2.3.8 Does the laboratory have a defined process for requesting and receiving approval to hire new personnel? 2.3.9 Does the laboratory have specific personnel assigned to purchasing and budgeting activities? 2.3.10 Do the personnel assigned to purchasing and budgeting have the proper skills and training to perform planning, budgeting, and purchasing activities? 2.4 Laboratory Administration and Operations 2.4.1 Does the laboratory possess work flow or process diagrams, at least for its primary operations, such as sample management, testing, data review and management, and reporting of results? Work flow diagrams or process maps are invaluable and lay the basis for efficient operations for most all tasks performed in the laboratory. See the Chapter 2 Appendix (www.wiley.com/go/Bliesner/LabControl_GMPEnvironment) for an example work flow diagram-template. 2.4.2 Does the laboratory have a general administrator, office manager, or similar administrative support person? 2.4.3 Does the administrator, office manager, or similar support person perform or supervise the following activities: 2.4.3.1 Managing work orders for office and laboratory repairs? 2.4.3.2 Overseeing stockroom operations? 2.4.3.3 Supervising requisition of administrative and operational supplies? 2.4.3.4 Managing external contractors and contracts? 2.4.3.5 Managing/enhancing communication between the laboratory and internal/external customers? 2.4.3.6 Supervising laboratory safety training and compliance? 2.4.3.7 Monitoring overtime billing? 2.4.3.8 Initiating capital equipment purchases? 2.4.3.9 Attending production planning meetings? 2.4.3.10 Representing the laboratory at Quality Council, Quality Review, or similar meetings where site-wide quality metrics are reviewed? It is critical that the QC laboratory be engaged with the other Quality Systems within the organization, particularly Manufacturing and QA.It is not unusual for the QC laboratory to become isolated from the other systems, which leads to an underappreciation of the challenges that exist for running a laboratory. It can also lead to unrealistic expectations regarding the volume of testing, which can be achieved and testing turnaround times, especially at the higher levels of management. Personnel at these levels rarely have laboratory experience and need to be respectfully educated on the nuances and challenges of running a QC laboratory. 2.4.3.11 Collecting, analyzing, reporting, and presenting quality metrics related to the QC laboratory (e.g. laboratory errors, challenges related to test methods, out-of-specification (OOS) and out-of-trend investigations (OOT) investigations, equipment issues, etc.)? See the Chapter 2 Appendix (www.wiley.com/go/Bliesner/LabControl_GMPEnvironment) for some example metrics. 2.4.3.12 Collecting, analyzing, reporting, and presenting operational metrics related to the QC laboratory (e.g. right-first-time on testing, testing turnaround times, testing backlogs, etc.)? 2.4.3.13 Managing regulatory agency inspections? 2.4.3.14 Managing internal and external audits? 2.4.4 Does the administrator, office manager, or similar support person perform or supervise keeping current with FDA and regulatory related items such as: FDA has several e-mails feeds to which you can subscribe, including notification of Warning Letters, Guidance Document updates, etc. through the Subscription Management Center: https://www.fda.gov/about-fda/contact-fda/get-email-updates You will receive automatic e-mail notifications to the topics with which you wish to stay current. 2.4.4.1 Recent Warning Letters? 2.4.4.2 Recently posted Form 483 observations? Electronic