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Without a Trace?

Compliance & Quality Compliance & Quality

For James J. Gormley’s September article on compliance and quality in the natural products industry, he interviewed Tony Blanch, Director of Quality and Corporate Services, Nutraceutix, Redmond, WA and John B. Atwater, PhD, RAC, CQA, Senior Director, USP Verification Programs, USP, Rockville, MD. Below are their thoughts on how automation can affect production.

NIE: Automation, such as barcode readers, has revolutionized accuracy and efficiency of production. In what ways do advancements in automation systems and technology enhance quality, compliance or traceability?

Blanch: The potential exists for integrated systems to provide full traceability from raw material through production and distribution of finished products to the individual package sent to the consumer. In addition to easy product recall traceability, these tools can be used to link consumers to far more information about their product than can be fit onto a label. Trace and track systems are being rolled out now that will allow the consumer to scan a QR (quick response) code and be directed to product testing and raw material sourcing information specific to the lot they have purchased.

Atwater: The use of automated systems and technology reduces documentation errors (e.g., transcription errors) and increases traceability of material use and activities for both production (e.g., electronic production records) and laboratory operations (e.g., electronic notebooks). It is important to note that automated systems encompass the hardware (i.e., computer system), software, operating environment, standard operating procedures, training plan, and related systems and processes. Automated systems need to be 21 CFR Part 11 compliant with regard to validation and the ability to generate complete and accurate records, limit system access, protect records, and produce time stamped audit trails.