When a pharmaceutical manufacturing facility is subjected to an review or assessment, the matter of FDA compliance is likely to be one of the most pressing factors that will have to be tackled. Pharmaceutical consultants are more and more being sought after to offer guidance and help on what will be wanted from a manufacturing [...]
Tags: FDA auditing, FDA compliance, GMP auditing, pharmaceutical consultants, QP training
The US Food and Drug Administration is developing its control over externally manufactured drugs in a bid to reduce the number of substandard medicines which enter the American market. Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting or PREDICT is a way to control the drugs which enter at the border. Barcodes on cases of [...]
Tags: FDA auditing, FDA compliance, GMP auditing, pharmaceutical consultants, QP training
The border control policy of the US Food and Drug Administration is being developed in an attempt to cut the number of poor standard medicines which enter the country from outside. The new initiative which is called PREDICT – Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting – will be a border-based scheme which assesses [...]
Tags: FDA auditing, FDA compliance, GMP auditing, pharmaceutical consultants, QP training