Your patients have no idea if a drug is safe. Based on their trust in you, they ingest pills, liquids and any other forms of drugs as instructed. They never stop to think about the pharmaceutical lab safety where their drugs were made. They have no idea if a barbiturate came in contact with and contaminated their blood pressure medicine.
When they take medication, patients do not wonder if the facility was clean, if the label machine was malfunctioning or if the employees have the flu while handling their medicines. They don’t ask if the equipment is running properly or to see the companies’ track record when it comes to errors.
As their physician, you need to make the effort to ensure the medicine you prescribe abides by all rules and regulations of pharmaceutical lab safety pertaining to creation, sorting and packaging of medications.
Good Manufacturing Practices
The Federal Drug Administration (FDA) sets forth Current Good Manufacturing Practices (cGMPs) that all laboratories must follow to ensure safety when dealing with pharmaceutical lab safety. These are the minimum requirements to pass inspection.
Hopefully, manufacturers are providing even more precautions on their own to ensure safety to the patient, which also helps protect you and your practice.
Some of the areas in which minimal requirements enforced by the FDA are listed below.
Pharmaceutical Lab Safety Of The Equipment
Equipment refers to any instrument used in the manufacturing of a drug product. This can include computers, processors, sorters and anything else in which the drug comes in contact. Every single piece of equipment must be inspected to ensure consumer safety.
Equipment must follow calibration requirements and are graded on how well they work and if adjustments are needed. They must carry their own identification number that is traceable. Calibration must also be measured on multiple points, usually three to five, on the instrument to check its ability throughout its use, not just at the beginning or end.
Each lab should have a technical representative on staff that will document and report all consistencies and inconsistencies that occur. Specific forms should be created by the facility. The forms and records kept by staff will also be inspected and graded by the FDA.
The Facility
The building where any drug product will be held, processed or packaged endures strict scrutiny for pharmaceutical lab safety by the FDA. The size and location of the building are just as important as maintenance and operations. They are broken down for inspection purposes as internal and external environments.
Manufacturers cannot just set up shop in an old building that has been sitting empty for years. Both the exterior and interior of the facility must be pristine and sterile. They must adhere to laws for zoning, clean water, and have a lack of problems with insects or rodents.
The facility must also be located nearby to where potential staff live, not in an area where a workforce would be inconvenienced.
Construction materials are determined by regulations and there is a lengthy list of requirements. Concrete walls, plaster and paint, flooring resistant to chemicals, and suspended ceilings are just a few examples of the requirements. Lighting, ventilation, plumbing, and sanitation regulations can bring consequences if the regulations on pharmaceutical lab safety are not correctly followed.
Facility owners must take into consideration how products will be disposed, that no eating or drinking takes place where medications are processed or packaged. If a staff member violates these rules, there are written ways they will be reprimanded.
Employees are evaluated and inspected just as much as the facility and equipment.
The Employees
A culture of compliance must be integrated throughout the company. One staff member could disrupt an entire process and create violations if they are not on board with understanding the importance of following regulations.
Training is provided to all staff, no matter what their duties. They are trained in how to keep the facility clean, how to properly handle and dispose of contaminated medication, and how to report errors in the manufacturing process.
Trained supervisors are responsible for making sure the rest of the staff follow guidelines. This includes making cleanliness of the facility and the staff a top priority. Staff must learn how to wash hands properly to dealing with their own illnesses such as the flu, learning when to call off sick.
Documentation is another key aspect of meeting FDA requirements for pharmaceutical lab safety employee standards. From every training attended, to every sick day taken, it must be recorded.
The Testing
Manufacturing facilities must do a lot of testing. And then they must test their testing methods. If the way they test the quality of the drugs they produce is not giving them the answers needed, they must improve it.
They can do this by creating new testing methods or by improving existing testing methods. Analytical test methods must be validated during each phase of the manufacturing process. The FDA has established diverse types of validation tools.
One tool is designed to test process, while another validates cleanliness. Others include computer system validation, methods and documentation. That’s right, more documentation, which can be seen as proof of quality control.
The Complaints
No matter what product you are manufacturing, someone is going to complain. Therefore, the FDA has set forth guidelines to handle all types of complaints, both internal and external. It starts with the manufacturer assuming responsibility for the error causing the complaint.
Then, the manufacturing facility must respond to the complaint according to regulations. Failing to do so can lead to consequences such as warning, fines and plant closures.
The process of responding to complaints includes recording information. Information gathering means getting every bit of data you can collect, even if you do not think it is useful right away, it may be later. The next steps are to assign and investigator to the case and begin the investigation. Then you can follow-up with results and make changes as needed.
The FDA requirements on pharmaceutical lab safety are extensive but set in place to protect patients, and you, from any negative effects.