Overcoming Data Integrity Challenges In Biopharmaceutical Production

By Calvin Kim, Samsung Biologics

Data integrity and the regulations associated with biopharmaceutical manufacturing may seem increasingly complicated, but technology and well-planned, risk-based strategies make it easier to adhere to these essential requirements.

To ensure the safety and efficacy of pharmaceutical products, the FDA and other regulatory agencies demand a high level of data integrity (DI) in GxP records associated with the manufacturing process. DI-related risks faced by pharma and biotech companies merit critical consideration because, while DI is not a new concept, regulatory scrutiny continues to increase due to a combination of industry growth, evolving technology solutions for DI control, and continued DI-related deficiencies in regulatory inspections.