Safety, of drug products

Impurities in a final product must be known and controlled. Without sufficient control of the quality of the drug substance, the safety of drug product is not assured. The FDA was formed to ensure that companies manufacturing and selling food and drugs control quality in order to protect consumers. Inadequate control of product purity and impurities also indicates that processing is not fully productive, as batches will be destroyed or reworked to improve the quality. With frequent need to rework batches, additional time is justified to optimize conditions. 

Drug Safety Evaluation has been written with the central objective of presenting an all-inclusive practical guide for those who are responsible for ensuring the safety of drugs and biologies to patients, health care providers, those involved in the manufacture of medicinal products, and all those who need to understand how the safety of these products is evaluated. 

Dotzel, M.M. (2000) Additions to the list of drug products that have been withdrawn or removed from the market for reasons of safety or effectiveness. Federal Register, 65, 256-258. 

Refer to Section 9.8.The risk-based approach directs resources to address issues according to risk levels to assure the safety and quality of drug products being manufactured. 

It is widely understood within the industry that risk is defined as the combination of the probability of harm and the severity of that harm. Within the pharmaceutical industry whenever risk is considered the equipment or product being assessed must be viewed in the context of the protection of the patient. From our perspective, analytical instruments may impact on the validity of data that determines the safety and efficacy of drug products, or on the quality of the drug product. They may also impact on the identity or potency of the drug product and therefore it is important to ensure that risk management is performed throughout the complete life cycle of the instrument. 

Equipment used in the compounding of drug products shall be of suitable composition so that surfaces that contact components, in-process materials, or drug products shall not be reactive, additive, or absorptive affecting the safety, identity, strength, quality, or purity of the drug product. 

The Food Drug Administration has the responsibility for the premarket clearance of all animal drugs. The 1958 food additive amendment to the Federal Food, Drug Cosmetic Act requires sponsors to demonstrate the safety of their products. The Kefauver-Harris amendment of 1962 requires the sponsors to demonstrate, in addition to safety, the efficacy of their drugs. Safety implies safety to the animal as well as to the consumers of animal products. The role of the Center for Veterinary Medicine in the premarket approval process is to establish conditions of drug use and to establish the allowable tolerances for drug residues in animal-derived food products. 

Many drugs will be used in elderly subjects, and certain diseases, for example, Alzheimer s disease, are associated with the ageing process. Clinical studies to test the efficacy and safety of medicinal products in elderly subjects need to take account of the following ... 

In order to permit a smooth transition, the two committees (that on Safety of Drugs and that on Safety of Medicines) met simultaneously from Jime 1970 onwards, the CSD continuing to appraise products for clinical trials and... 

Regulations were introduced to lessen the administrative load on the authority and to simplify the procedure for granting a postapproval variation without negotiating any quality attribute of drug product [10]. Under these regulations, type IA and type IB were defined also, clearcut terms were introduced for extension application, parallel/consequential notification/variation, and urgent safety restriction. For streamline operation of these regulations, four documents have been prepared ... 

---