The Most Important Compliance Best Practices You Need to Know

Analytical methods play a key role in assuring that drug substances and drug products conform to their specifications. Analytical methods should be validated to ensure reliability, consistency and accuracy of analytical data. Method validation has been a requirement of FDA and international regulations and accreditation standards since many years. Inadequacies in the validation process can incite FDA Warning Letters. 

The explosion in use of social media over the past few years has been both a blessing and a curse for life sciences companies and consumers who use their products. While platforms such as Facebook and Twitter might present a great opportunity for marketing products, the limitations of the tools can present regulatory pitfalls for companies and dangers to consumers. The rapid pace of technological progress has caught agencies such as the FDA and FTC on the wrong foot and they have struggled to formulate and implement regulations on social media use. It is clear though that the onus for compliance lies with regulated companies. However, the overlap between regulations for conventional marketing and promotion and social media guidelines that are still evolving has led to confusion about compliance requirements. This white paper discusses 5 ways in which drug and device companies can stay on the right side of the regulatory agencies and ensure that they don’t attract penalties for violations.

When the FDA inspector calls, even the most experienced professional can lose confidence and make the inspection process more painful and confrontational than it needs to be. Firms are very often unsure of how to deal with the FDA inspector’s requests and can complicate matters by becoming too antagonistic or go in the opposite direction and volunteer more information than necessary. This white paper discusses different types of FDA inspections and the seven best practices that FDA regulated companies can follow in order to ensure a trouble-free FDA inspection process that reduces the risk of multiple and unnecessary Form 483 observations.

Compliance with the principles of GLP (Good Laboratory Practices) is a legal requirement for test facilities. After each GLP study is completed or terminated, a GLP final report must be prepared for submission to the regulatory agency. Test facilities should follow GLP guidelines and good archival practices as non-compliance compromises the quality and integrity of the study and gives scope for rejections,warning letters and citations by the FDA. This white paper primarily intends to provide information about necessary documentation, requirements for GLP final reports, and also details about best practices to be followed in final reporting and archiving for regulatory compliance.

Good Laboratory Practice, a regulation instituted in 1978, intended to regulate non-clinical laboratory safety studies. The outcome of these studies gave researchers the insight into safety of the new molecular entities for human trials or clinical trials.

The main laboratories that were affected by the regulation were ones conducting clinical chemistry, histology and pathology, which are used to analyze the samples generated from toxicology studies.

What are the aims of GLP? What are the key differentiators from other regulations? What are the various GLP organizational roles and their responsibilities?