One of the more delicate industries today is pharmaceuticals, and pharmacists, lab technicians, chemists, and more are always hard at work making new medicines. To get this delicate work done, strict clean room standards must be maintained, and GMP standards, or “general manufacturing practices,” should be kept in mind as well. GMP quality assurance can go a long way toward ensuring that clean room standards are met, and that a product is carefully inspected and ready for safe use. GMP quality assurance is key to finishing a product today, and GMP storage conditions should be to a high standard as well. Just how large is today’s industry for chemicals and pharmaceuticals today? How can clean room standards make a difference in all this?
The Modern Pharmacy Industry
Medicine is always needed by the general populace, and this makes for a robust industry that has some strict quality assurance standards around it. In the modern age, nearly 810,000 Americans are hard at work in the chemical companies across the United States, and this includes the pharmaceutical sector, too. This is an enormous industry; in fact, the American pharmaceuticals industry holds 45% of the world’s pharmaceutical market. Similarly, the United States stand as the world’s single largest chemicals producer. All of this is exacting work, and the right hardware must be in place, and the correct safety standards followed, for the best results.
Clean room standards are one such way to maintain GMP quality assurance in a hard day’s worm. What does this entail? Humidity, for one, is a major factor in keeping a clean room up to standard. To maintain clean room standards, electronic sensor devices are used to maintain and monitor the clean roomn’s humidity. The humidity can be controlled with precision as accurate as 1% with modern sensors, and this can go a long way toward keeping a clean room running smoothly. On top of that, workers in a clean room may be expected to wear body suits, eye goggles, gloves, and more to prevent contamination while they are at work. A rip or tear in someone’s gloves or suit can bring operations to a halt until the contamination can be corrected. Gloves, goggles, suits, and more should be regularly checked for any defects or other issues before use, and they can be sent for repairs or replaced right away.
Replacing the fume hood is another factor to consider. A laboratory’s fume hood should be checked over once per year by an independent certifier, and this will ensure that it has correct air flow to meet Cal/OSHA criteria. A recent survey found out how often lab crews intend to work on their fume hoods. In that survey, it was found that one in five labs was set to replace the fume hood, and one in three of those replacements was necessary due to the hardware’s old age.
GMP quality assurance takes other forms, too. The proper paperwork should be done to log everything that happens at the work site, and this can make it much easier for staff members to accurately log how much material was made. This is also essential for tracking rates of accidents or customer complaints about products, and fixing an error with the product will be made much easier if there are logs to consult. During a typical work day, staff members may log who worked on what task, and what was produced and in what quantity. Should a mistake be made, or if a customer sends back faulty items, this can and should be recorded as well to smooth out the correction process. Such logs and details can also help a company prove that it is meeting OSHA and other standards of the workplace, should an inspection or audit be performed by another agency. These logs can also be useful if customers mention a lack or excess of products, or the wrong kind. These complaints can be checked against the lab’s own records to figure out the cause of the discrepancy. Finally, this logged information can be useful when an official inspection is carried out, and the lab can prove what sort of work it did, and when, and with what quality standards.
