If you work in the pharmaceutical industry then you likely accept that health and safety rules and regulations exist for consumer safety. They also ensure that all drugs that are brought to market are effective and do exactly what they are intended to do. Needless to say, there is often much scrutiny around compliance from investors, regulators and even the public. It is therefore crucial that compliance in the pharmaceutical industry is up to standard or there can be serious repercussions. After all, this is an industry where there is no slap on the wrist – fines are heavy and your business cannot afford to risk them. So, how can you ensure your firm remains compliant in such a highly regulated industry?
Make sure you have written guidelines for compliance procedures.
A 2019 study of the most common citations issued in 2018 by the FDA in the US found that lack of written standard operating procedures came in at number 4. As one of the panellists stated “ We understand that things are going to go wrong. How you handle it when it goes wrong is what we care about.” That means that you need to have a set of safety guidelines for standard procedures as well as a set of guidelines for when procedures are not followed.
Not only is having a clear set of procedures a requirement for compliance, but they are also critical for ensuring quality and safety within the work place.
Sanitise, Check, Record.
It’s one thing having procedures in place, but you also need to be following them. Unsurprisingly, maintaining a sanitised environment is crucial for the production of pharmaceuticals. There is always a danger of contamination, and all staff must take proper precautionary measures to ensure that neither they nor the product is at risk. All incoming and outgoing batches must be tested regularly according to their requirements. That includes temperature testing, and raw material identification and verification. Instruments such as Progeny by Rigaku are invaluable when it comes to this area.
Additionally, you must ensure that you are keeping an updated log of any checks or tests that you do. Should your business be subject to a safety audit, this will likely be one of the requests from the visiting officer. You also need to ensure that all equipment is not just sanitised but being properly maintained. If not, it could be subject to malfunction, which could have disastrous consequences!
Investigate every discrepancy.
Of course, keeping a log of all tests or checks conducted is also key to discovering what might have caused any errors in production. It is your responsibility to fully investigate any discrepancy that may occur in any batch of drugs, and ensure that you and your business are maintaining absolute quality control at all times.
However, when it comes to quality control in the pharmaceutical industry, the best cure is always prevention. Ensuring that you and your business is compliant in the first place is better than dealing with the mess that follows if you’re not. If you’re unsure about your compliance standards make sure to reach out to the relevant regulatory body for advice.
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