Issue link: https://www.e-digitaleditions.com/i/1199406
32 January 2020 Tablets & Capsules define the critical quality attributes (CQA) of the prod- uct being manufactured and ensure that CQA data is automatically sent from the equipment to servers, is backed up per schedule, and is periodically tested for retrieval of data and metadata to ensure that the data is attributable, legible, contemporaneous, original, and accurate (ALCOA). This requirement is often overlooked when installing new equipment. Formal change control for new equipment, and even equipment that is moved from one location to another, must include an ALCOA assessment when connecting to GMP networks. This is particularly important when installing additional network data cabling to accom- modate newly purchased equip- ment. The net work architec- ture must be able to identify the equipment connected to specific data port IDs located in clean- rooms and map the equipment's data to secure and compliant server locations. FDA warning letters for com- puter networks cite the failure of valid ation documentation to include complete updated design documentation, and com- plete wiring/network diagrams to identif y all computers and devices connected to a system. Given that net works change frequently, maintaining accu- rate diagrams that reflect the network's current configuration requires revision control (formal change control). Addi- tionally, the World Health Organization (WHO) guid- ance on validation of computer systems states that GxP computer systems and network validation should include the system physical and logical architecture and map out the relevant workflows and data flows. Drainage. Drainage is the most difficult utility to retrofit, and not all drains are created equal. Some are designed to transfer liquids directly to normal waste streams, some treat the effluent before sending it to city waste, and others capture the effluent so it can be taken away and processed. Ensure that the room in which new equipment is to be installed has the proper drain system with floor connections next to the intended equipment location. If the room does not have drains or has the wrong type of drain, be prepared to spend big dollars and allow for significant downtime to trench new drains. Note that, depending on the city or state, a permit will likely be required for the new drainage. Explosion proofing. Pharma- ceutical production equipment and cleanrooms, including those than employ solvent handling and processing, such as spray drying, are categorized in terms of their explosion potential. In North A merica, hazardous location electrical codes and standards use a "class, division" system as the basis for classifying hazardous locations. Locations are divided into three classes based on the type of hazard and the explosive characteristics of the material and two divisions based on the occur- rence of risk of fire or explosion the material presents. You can mitigate the potential for explosions in cleanrooms by ensuring that electrical outlets, lighting, and sources of heat and spark are separated from the surrounding envi- ronment to protect them from dust, moisture, vapors, or other contaminants. This isolation can also protect the surrounding environment from outgassing, heat, arcing, air pressure leakage, electromagnetic interference, and other conditions that could negatively affect process integrity and personal safety. In cases where cleanrooms can pose an explosion risk based on the materials that will be processed, it's prudent to seek the advice of a qualified industrial electrician or other expert to assess the controls currently in place and determine whether additional protection is needed. This is particularly important for manufacturing processes that don't use physical containment or isolators to trans- fer flammable materials and solvents from one piece of equipment to the next and rely solely on the cleanroom infrastructure for protection. Some types of production equipment, including specialized computers, are certified to meet the requirements of the specific hazardous loca- tion class and division to provide an extra level of protec- tion for the process, facility, and personnel. GMP networks and servers. When connecting new equipment to GMP networks and servers, you must FDA warning letters for computer networks cite the failure of validation documentation to include complete updated design documentation, and complete wiring/network diagrams to identify all computers and devices connected to a system. Photo 1: Ensure that the room in which new equipment is to be installed has the proper drain system with floor connections next to the intended equipment location or be prepared to spend big dollars and allow for significant downtime to trench new drains.