The legal requirements for the Pharmaceutical and the Lifesciences industry is changing round the clock. Maintaining a cost effective, robust, error free system is the prime concern of any competent authority.

21 CFR Part 11, CGCP, CGMP, to name a few, form the fundamental elements of managing quality assurance in the Pharmaceutical and Lifesciences industry. As a result, US FDA is increasing emphasis on scrutiny of computer systems validation. In the last five years, companies have been tasked with addressing numerous provisions that stem from an increase in compliance demands. In the areas of security and privacy, daunting legislation such as The Predicate Rules (GCP, GLP, GMP), 21 CFR Part 11 as well as federal and state requirements, have required extensive assessments of business practices.

From an IT standpoint, there are intrinsic benefits to compliance for an organization’s operations. Hence, being compliant with universally accepted guidelines not only increases the system security but makes it different from the rest in the market. The security and privacy of compliance can be formed as a baseline for the sharing and archiving data.

Harmonization of regulatory requirements was pioneered by the European Community (EC), in the 1980s, as the EC (now the European Union) moved towards the development of a single market for Pharmaceuticals and Lifesciences sector.

ICH has been successful in achieving harmonization, initially of technical guidelines and more recently on the format and content of registration applications. All parties agree that there is a need to maintain this harmonization in the interest of public health to prevent unnecessary duplication without compromising the regulatory obligations of safety, quality and efficacy.

In 1997, the US FDA made an addition to the Title 21 of the Code for Federal Regulations as Part 11 taking proactive steps in the field of managing electronic documents and electronic signatures. With the Part 11 coming into effect, companies in the field of Pharmaceutical and Lifesciences have been tasked with the proper maintenance and should be able to produce those documents as and when demanded by the compenant authorities.

US FDA ensures the quality of drug products by carefully monitoring drug manufacturers’ compliance with its CGMP regulations. The CGMP regulations for drugs contain minimum requirements for the methods, facilities and controls used in manufacturing, processing and packaging of a drug product. The regulations make sure that a product is safe for use and that it has the ingredients and strength it claims to have.

The approval process for a new drug and generic drug marketing applications includes a review of the manufacturer’s compliance with the CGMP. US FDA inspectors determine whether the firm has the necessary facilities, equipments and skills to manufacture the new drug for which it has applied for approval.

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.

The objective of this ICH GCP guidelines is to provide a unified standard for European Union (EU), Japan and United States to facilitate mutual acceptance of clinical data by regulatory authorities in these jurisdictions.

Risk assessment during product development should be conducted in a thorough and rigorous manner; however, it is impossible to identify all safety concerns during clinical trials. Once a product is marketed, there is generally a large increase in the number of patients exposed, including those with co-morbid conditions and those being treated with concomitant medical products. Therefore, post-marketing safety data collection and risk assessment based on observational data are critical for evaluating and characterizing a product’s risk profile and for making informed decisions on risk minimization.

The term pharmacovigilance means all scientific and data gathering activities relating to the detection, assessment and understanding of adverse events. This includes the use of pharmacoepidemiologic studies. These activities are undertaken with the goal of identifying adverse events and understanding, to the extent possible, their nature, frequency and potential risk factors. Pharmacovigilance principally involves the identification and evaluation of safety signals.

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