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Senior pharmaceutical executives must play a more active role in overseeing GMP initiatives under the FDA’s new approach to risk management, according to an industry expert who urged firms to start applying quality manufacturing concepts earlier in the drug development process.
Selecting the right members for your computer system validation (CSV) and 21 CFR Part 11 compliance teams will have a lot to do with whether your efforts are successful, an industry expert said.
The FDA has shifted its regulatory focus from software to whole computer systems — and regulated life sciences companies must adjust for that when developing effective validation programs, former FDA investigator Martin Browning said at a recent FDAnews audioconference.
Though it has shifted hard away from active Part 11 enforcement or even much public discussion of the rule by name, the FDA remains committed to seeing that regulated firms can demonstrate that their computer software does what it is supposed to do, experts tell PIR.
Poor design and weak user requirement documents are often the root cause of computer system validation (CSV) and other erecord and compliance problems, according to noted expert Kim Nitahara, chairman and CEO of META Solutions.
Some pharmaceutical industry professionals recognize outsourcing is a cost-effective solution for relieving overworked in-house staffs, adding specific expertise as needed and stabilizing far-flung cyclical workforces. However, outsourcing is not an excuse for abdicating responsibility for regulatory compliance, an industry expert said.
Manufacturers must find the right number of subject matter experts (SMEs) when developing a firm’s standard operating procedures (SOPs), said an industry executive who warned this decision can be the hardest part of implementing an SOP.
The key to adhering to a predicate rules-based system for GMP and using a risk-based approach for computer system compliance successfully is to understand how systems are being used as part of the entire process, understanding if and how your company is relying on the system and understanding the impact of the system, according to an industry expert.
Medical devicemakers can prevent manufacturing problems and improve product safety by applying the Hazard Analysis and Critical Control Points (HACCP) technique to their operations, according to a HACCP-certified auditor.