Expiration dating and stability testing for human drug products
Expiration dating and stability testing for human drug products - dating an exotic dancer story
Since the early 1970s, it has become a concern that unstable Drug Products (DPs) may not be able to maintain their quality attributes after being stored over a period of time, so, in 1975, the United States Pharmacopeia (USP) included a clause regarding the drug-expiration-dating period.In 1993, the International Conference on Harmonization (ICH) issued the guidelines on stability (Table 1).
For the majority of drugs sold in the United States, these dates range from 12 to 60 months from the date they are manufactured. Your medications may expire before the expiration date if improperly stored, or they may last well beyond their expiration date, as some studies have shown.
This type of testing ensures that a drug’s potency and integrity are intact over a specific amount of time, which becomes the expiration date.
Several factors can influence these dates, including type of active ingredients, storage conditions, preservatives, and the kind of container the drug is stored in.
Quality, safety and effectiveness are the most important attributes of drugs and pharmaceuticals.
Because of its key role in public health, the pharmaceutical industry has always been a comparatively highly regulated industry.
While most drugs do not become dangerous when expired, they can still pose a threat to your health. Using a drug past its expiration date may affect its quality and effectiveness.
Pharmaceutical manufacturers determine a drug’s shelf life, or expiration date, through stability testing.
As a Contract Research Organization, we are recognized for the analysis and control of pharmaceutical products by the Belgian Ministry of Health.
Our laboratory is GMP inspected and recognized by the Belgian Federal Agency for Medicinal and Healthcare Products (FAMHP), GLP certified by the Scientific Institute of Public Health (IPH) (Identification number: T02), FDA registered (FDA Establishment Identifier (FEI): 3005742674) and ISO 17025 accredited by BELAC (Identification number: 363-TEST) and all testing is carried out according to European GMP Guidelines.
The second division ‘Extractables and Leachables’, focuses on chemical compounds released under appropriate conditions from the Medical Device into the Drug Product.
This combined approach results in optimized study design and cost efficient budgeting.
The frequency of medication errors associated with drugs formulations is unknown, but dosage errors can produce toxic results.