Manufacturers of medicines have to make sure they produce high-quality products that are effective and safe to use. They have to follow the guidelines set by the US Food and Drug Administration (FDA) in the quality control measures in the laboratory that they use in producing medicines. While there might be changes in the process, manufacturers should stay updated to ensure they comply with the requirements. Let’s see ensuring the efficacy and safety of manufactured medicines.
These manufacturers have to consider several things to comply with the quality standards set by the FDA in the production of medicines for different illnesses in the country. Here are the things that medicine manufacturers should take into account.
Ensuring the Premises is Clean
The first thing that manufacturers should consider is to ensure their premises are clean. Manufacturers even make sure that the production area hasclean flooring. This ensures the area does not have any contaminants that can affect the safety and efficacy of the medicine.
The design of the place should facilitate sanitation and allow personnel to clean and maintain it easily. Its layout should facilitate the prevention of cross-contamination and dirt buildup. It should also prevent the entry of pests, and the facility should have an Integrated Pest Management program to eliminate pests already on the premises.
Regular cleaning and disinfection of the premises are also important, especially in the middle of a pandemic. Manufacturers should also manage humidity, temperature, and ventilation in the premises to prevent adverse effects on the products and equipment.
The manufacturer should also provide separate washing and changing facilities from the storage and production area. The emergence of the delta variant of the virus made it essential for manufacturers to provide washing facilities for their workers.
The storage areas should also be clean, dry, and well-lit. The manufacturer should make sure to maintain the temperature of these areas.
Proper Handling of Materials
After checking the premises, manufacturers should also make sure their employees handle and store the materials properly. In the past, manufacturers used buckets to bring powders used for compounds to different parts of the facility. This resulted in inefficiency and exposed the employees to toxic chemicals. While manufacturers later used improved the handling process, it still required fine-tuning to ensure the safety of both the employees and the products.
Manufacturers should make sure their containment and transport systems are reliable. They can use bags made of durable fabrics and strong film liners to facilitate the proper handling of materials.
To ensure the materials are safe and clean, the manufacturer should store pest control materials away from the components of the medicine. They should also avoid storing insecticides and rodenticides close to packaging materials and equipment.
Ensuring the Purity of the Product
With better handling of the materials used for the medicines, manufacturers can ensure the purity of their products. This reduces instances of product recalls since the manufacturer can ensure their products have no impurities.
Organic impurities in a product come from the original components, by-products, and synthetic materials used for the medicine. Inorganic impurities result from issues during the manufacturing process. (johnsonstring) When manufacturers deal with these issues during the process, they can eliminate impurities in their products.
Some components in the products of pharmaceutical manufacturers are hazardous to the health of people. So, they should make sure to provide their employees with the necessary protective equipment. This is particularly true if they handle High Potency Active Pharmaceutical Ingredients (HPAPIs). They need to wear powered air-purifying respirator (PAPR) systems to protect them from airborne particles from chemicals and drug compounds. But the manufacturer must also make sure the safety equipment allows employees to move properly since many systems are bulky and unwieldy.
Aside from ensuring employees’ health while working on the production floor, manufacturers should also conduct regular health checks to ensure everyone in the facility is not infected with the virus. It should also emphasize the importance of maintaining their hygiene.
Employees should also be advised to stay home and have themselves tested if they feel sick. Encouraging the employees to get vaccinated is also another option to protect them from the virus. The spread of the delta variant has made it advisable for people to wear a mask while inside a building.
The employees wear protective equipment while in the production area, but they should also wear a mask when they go out of these areas. The manufacturer can also set up hand sanitizer stations to encourage the employees to disinfect while on the premises.
Manufacturers should implement measures to ensure the safety and efficacy of the medical products they offer in the market.