Dear Reader,

Here are some definitions and elaborations on the role of Quality Assurance and Regulatory Affairs in Clinical Research and in an Organization:

Role of Quality Assurance in an Organization: Quality Assurance in a company regulates the compliance of guidelines set by regulatory agencies such as FDA (Federal Drug Agency), ICH (International Conference on Harmonization), TPD  (Therapeutic Product Development, Canada) and helps to plan the process of the company to keep up with the expected quality which is required for it’s success.

Difference between the role of Quality Assurance and Regulatory Affairs: QA is the organizational body that ensures quality compliance within the industry whereas Regulatory Affairs mainly deals with the agencies and is responsible for answering any compliance related issues that they may have.

    Importance of maintaining QA documentations: The purpose of maintaining QA documentation is to maintain a proper planning; a historical   background of the work and also it is a cGMP requirement. A good documentation is very important for good quality. Given the rapidly evolving drug development expansion of clinical trials, increasingly there is  the need for voluntary GCP-related quality assurance of clinical trial activities by industry sponsors.  Regulatory agency requires that companies specify, in their NDAs whether auditing was conducted or not for a particular study. According to the FDA’s August Part11 A scope and Application guidance, it gives the organizations freedom to maintain both paper and electronic versions of records however a written SOP must let the FDA know which version of documentation should be used by FDA for inspection purposes. Organizations must make sure that personnel are properly trained in their use and must ensure that all the personnel are using the same version or level.

 FDA does not intend to object if you decide to archive required records in electronic media. Persons still must comply with all predicted rule requirements, and the records themselves and any copies of the required records should preserve their content and meaning.

 ICH GCP and FDA GCP : FDA maintains that its GCP regulations are entirely consistent with the ICH guidelines. However, inspections are mainly focuses on finding deviations from FDA GCP guidelines.

Type of document that FDA can access while visiting a site: FDA can have access to any records and reports related to IND  code 21 CFR 312.58(a)> Agency cannot have access to personnel file and their personal information except qualifications. 

 What is OSHA: Occupational Safety and Health Administration (OSHA) is the primary federal regulatory agency involved with employee health and safety. It was formed in 1970 to assure proper health of every man and woman at work in the nation.

 What is HIPAA: The full name of HIPAA is “Health Insurance Portability and Accountability Act of 1996”. This covers health plans, health care providers that transmit the health information electronically. In general HIPAA is referred to as Privacy Rule

  Please check our website frequently for more information on the topics.

BayBiotech Team