| In the pharmaceutical industry, it can be difficult to | | | | tasks. This is unfortunate since the first three stages |
| find a quality system model that provides a | | | | of maintenance are prime opportunities for |
| rendezvous point for conformance (either directly or | | | | automation. |
| indirectly) with the FDA's cGMP initiative, 21 CFR | | | | The benefits of automation are obvious: |
| Parts 210 and 211 regulations, the FDA's Critical Path | | | | |
| Initiative, ISO 9000 standards and/or the | | | | 1. More time for analysis and related research |
| requirements of foreign regulatory bodies. | | | | 2. Less administrative responsibility |
| The FDA however presents a potential model in the | | | | Quality management personnel in regulated |
| Quality Systems Approach to Pharmaceutical cGMP | | | | pharmaceutical environments can take advantage of |
| Regulations1 guidance document that may provide | | | | "automation benefits" by searching for software |
| the building blocks that pharma companies need to | | | | solutions that can be an "observer" of a company's |
| begin or continue developing a high-functioning quality | | | | quality system. In short, these solutions should |
| system that will help meet all of the regulations | | | | provide the data and trending technology that makes |
| requirements mentioned above. The FDA's suggested | | | | it easy to identify deviations and nonconformance |
| model is divided into four main categories: | | | | events. The solution(s) should also provide |
| - Management Responsibilities | | | | sophisticated auditing software and should also allow |
| - Resources | | | | for the easy creation of reports that reflect data |
| - Manufacturing Operations | | | | trends. With effective automation technology, the |
| - Evaluation Activities | | | | most important responsibilities of quality system |
| The focus of this article will be on the first category: | | | | maintenance are still in the hands of management but |
| management responsibilities---and will comment not | | | | timely and tedious administrative tasks become a |
| only the stated responsibilities of management | | | | "thing of the past." |
| (provided by the guidance document itself) but on | | | | Responsibility #2: "Plans Should be Aligned with a |
| the possibilities for the automation of many tasks | | | | Manufacturer's Strategic Plans to Ensure that the |
| (often administrative) that are associated with | | | | System is Part of the Manufacturer's Mission and |
| pharmaceutical quality systems management. | | | | Quality Strategies."3 |
| Responsibilities of Management Personnel in Regulated | | | | A quality system-regardless of the type-is never an |
| Pharmaceutical Environments | | | | entity unto itself. It has its metaphorical noses in |
| According the FDA's Quality Systems Approach | | | | everybody's business. That is why it is essential that |
| quality system model, management personnel in | | | | the quality system plans of any pharmaceutical |
| pharmaceutical environments should be responsible | | | | company be melded into the goals and realities of |
| for the following: | | | | other systems and processes that occur throughout |
| Responsibility #1: "Senior Management Should | | | | the pharmaceutical environment. It can be difficult |
| Demonstrate Commitment to Developing and | | | | however to align quality system management with |
| Maintaining their System"2 | | | | other processes and departments (even beyond |
| The development of such a system takes time and | | | | manufacturing) because departments have a natural |
| dedication. No matter how much a quality manager | | | | tendency to be disjointed and subjective. |
| may know about the complexities and the "ins and | | | | Automation-if the right solution(s) are provided--can |
| outs" of various models, he or she will invariably need | | | | allow pharmaceutical companies to essentially connect |
| to demonstrate a commitment to the development | | | | quality, compliance and everyday procedural |
| of the quality system itself. Management personnel | | | | processes with solutions that are launched from one |
| also have the responsibility of system maintenance. | | | | platform (management should look for a web-based |
| Quality system maintenance can be described in five | | | | platform). The benefits of one-platform, centralized |
| stages: | | | | automation are at least two-fold: |
| | | | |
| 1. Observation of quality system | | | | 1. Faster and more effective communication between |
| 2. Identification of deviations and nonconformance | | | | departments |
| events | | | | 2. Less errors due to manufacturing and quality |
| 3. Reporting | | | | disconnects |
| 4. Analysis | | | | Conclusion |
| 5. Appropriate Action | | | | In the pharmaceutical industry, it would seem that |
| Management should be responsible (at least to | | | | the facets of managerial responsibility are |
| reasonable degree) in all aspects of system | | | | innumerable. However, modern quality management |
| maintenance and will often carry the most important | | | | solutions (GxP management solutions for instance) |
| responsibility of data analysis and subsequent decision | | | | have been designed to consolidate and considerably |
| making (stage four). However, managers often | | | | ease the efforts required by pharmaceuticals |
| spend most of their energy on stages the heaviest | | | | management personnel. |
| burden at stages two and three and even on stage | | | | Reference |
| one which essentially (at least below the strategy | | | | 1-3: fda.gov/CDER/guidance/7260fnl. |
| level) are nothing more than tedious administrative | | | | |