Concerns related to the efficacy and safety of medical drugs have caused most governments to develop regulatory agencies to oversee development and marketing of drug products and medical devices. There is always room for improvement of an organization’s management systems. ANSI/PDA Standard 001-2020: Enhanced Purchasing Controls To Support The Bio-Pharmaceutical, Pharmaceutical, Medical Devices And Combination Products Industries contains procedures that describe the operating instructions and best practices for manufacturers of FDA-regulated products.
How was the FDA Created?
Before the Pure Food and Drug Act of 1906, the U.S. government had no formal oversight of medicine, food, and cosmetics—leaving issues of quality and purity to the individual states or manufacture. This lack of regulation was not much of a concern then because people made their own goods or purchased them from locally owned shops. As more people moved into cities to work in factories, city dwellers could not produce these medicines themselves and needed access to these products.
As drug products gained in popularity, horrific stories regarding both workplace and product safety were exposed, such as in Upton Sinclair’s The Jungle (1906). The report detailed the abysmal working conditions in a Chicago meatpacking plant where rotten meat and poisoned rats were knowingly ground-up, canned, and sold to consumers. Additionally, medications like Mrs. Winslow’s Soothing Syrup for teething and colicky babies contained ingredients such as morphine and alcohol that were not disclosed.
President Theodore Roosevelt signed the Pure Food and Drug Act in 1906: Congress moved legislation to prevent the “manufacture, sale or transportation of adulterated, misbranded, poisonous, or deleterious foods, drugs, medicines, or liquors.” The law was enforced by the Bureau of Chemistry in the Department of Agriculture; the bureau became the Food and Drug Administration (FDA) in 1930. The FDA is charged with protecting the health of the US public and it is the US government agency involved in the oversight of prescription medications, including how these are advertised to the public.
What Is ANSI/PDA Standard 001-2020?
ANSI/PDA Standard 001-2020 ensures awareness of the requirements for purchasing controls for a specific material, component, product, or service throughout the product lifecycle and that the responsibility for compliance at all stages is shared throughout the entire organization, with final responsibility falling to the management of the company. Current quality management systems can be made more effective in preventing counterfeit, substandard, or adulterated materials from entering the market and potentially harming patients. Implementation of risk-based processes will better define purchasing controls responsibilities, authorities, and accountabilities.
The procedures in this American National Standard describe the operating instructions and best practices for manufacturers of FDA-regulated products. ANSI/PDA Standard 001-2020 is intended to expand on the requirements already defined under FDA regulations for pharmaceutical products, medical devices, and combination products and ICH guidance. It represents current thinking on the topic and should be viewed only as recommendations, unless activities in the document are specified by a regulatory or statutory requirement.
Chief Procurement Officer
A Chief Procurement Officer or a management-designated equivalent is the individual within an organization that can help a company ensure compliance throughout the procurement process. This person provides management, administration, and supervision of the company’s acquisition programs. Additionally, ANSI/PDA Standard 001-2020 maintains that the Chief Procurement Officer should provide supporting activities and confirm adherence to regulations like the Phase-Appropriate Good Manufacturing Practice regulations for:
- Product development
- Clinical study supplies
- Quality control
- Manufacturing drug products, medical devices, and combination products
- Processing drug products, medical devices, and combination products
- Packaging drug products, medical devices, and combination products
- Storage of drug products, medical devices, and combination products
- Distribution of drug products, medical devices, and combination products
The First Medicine Invented in a Lab
The first medicinal drugs came from natural sources and existed in the form of herbs, plants, roots, vines, and fungi. For a long time, remedies were based on trial and error, superstition, and uncertainty about how the human body worked. Over the 1500s and 1600s, people in Europe started using opium—a milky sap from the poppy plant— to treat pain. Laudanum was a mixture made of opium, alcohol, and herbs (it was highly addictive) that helped with pain, insomnia, coughing, and diarrhea; it was used to treat nearly everything, from colds to the Black Plague.
Over the next 150 years, scientists learned more about chemistry and biology. In 1804, Friedrich Sertürner, a German scientist invented the first modern, pharmaceutical medicine. He extracted the main active chemical from opium in his laboratory and named it morphine (after the Greek god of sleep). Sadly, Sertürner became addicted to his own drug and warned people to be careful with it. Doctors used morphine to treat severe pain, and we still use it for that purpose in hospitals today.
In 1820, quinine was discovered as a cure for malaria. Paracetamol was invented in 1877. In the 1890s scientists first made aspirin from the bark of the willow tree, and we still use aspirin to treat headaches, fever, and inflammation. The first antibiotic, penicillin, was accidentally discovered in a lab in 1928 and is still used to treat infections caused by bacteria. Before penicillin, there was no effective treatment for infections, such as pneumonia. Since the 20th century, thousands of new remedies have since been created in laboratories, and presently more medicines are being developed using biotechnologies like bioprocessing.
ANSI/PDA Standard 001-2020: Enhanced Purchasing Controls To Support The Bio-Pharmaceutical, Pharmaceutical, Medical Devices And Combination Products Industries is available on the ANSI Webstore.
