Compliance Guide To 21 CFR Part 11

The execution of 21 CFR Part 11 might look costly as well as might require a lot of work, but this has definitely standardised the process for electronic records.An insight by Pooja Patil, Corporate Communications, B&R Industrial Automation.

EVERYONE IN in the pharmaceutical industry is well aware of the stringent laws and standards being set by the US Food and Drug Administration (FDA). The US FDA is responsible for the safety and efficacy of medicines and food products. It has comprehensive laws and regulations for pharma manufacturing practices to ensure quality, purity and safety for individuals. Sometimes, the smallest deviation from standards can result in entire batches being rejected or recalled after they are out in the market. In grave circumstances, a company’s license could be at stake.

Compliance with standards, allows pharma companies to enhance product quality and meet standards. All these stringent requirements, task pharma companies across the globe to examine data at every stage of the manufacturing process, right from the time raw material arrives until the final product is packed and shipped for distribution. In many ways, data quality is extra important for pharma companies. After all, mistakes in this industry can literally be fatal. In traditional pharma facilities, the references and information about drug formulation, production and equipment and data of QA-QC were manually entered in data sheets, which were prone to human errors or could stand a chance of manipulation. The pharma industry needs accurate and reliable data to ensure safety, efficacy and quality of products. FDA has answered these challenges with 21 CFR Part 11 regulations.

Benefits of 21 CFR Part 11