Pharmaceutical industries are involved in manufacturing of various pharmaceutical products ranging from OTC to life saving products.
Many types of guidelines & rules are implemented for production of these products which are handled by thousands of Wrong premployees in pharma.
In this article we will discuss 7 most common mistakes which are repeated in many (not all) pharmaceutical industries & the list is given below
- Use Of Cosmetic,Jewelry & Makeup
- Use Of Cell Phone
- Miss Use Of Mask & Gloves
- Data Integrity
- Avoid PPEs
- Wrong Use of Emergency Exit
- Ignorance Of Area Maintenance
Use Of Cosmetic,Jewelry & Makeup
According to many guidelines & standards, the use of cosmetics, jewelry & makeup is strictly prohibited in the manufacturing facilities.
You must have to remove all these before entering into the manufacturing unit because they may result in contamination, cross contamination or serious harm.(use of jewelry).
Apart from having strict SOPs & instructions it is generally observed that the use of all above-mentioned objects is common in many pharmaceutical industries.
Brainstorming
Everyone in pharma is aware of the fact that the above mentioned objects are prohibited, so why is there no strict check & balance in many pharmaceutical industries?
Use Of Cell Phone
Cell phones are a good source of communication but at the same time it is a big cause of accidents on roads as well as in pharma.
Workforce working in a manufacturing area or operating a machine must not allow the use of cell phones during operation because it may result in poor product quality & even serious harm to operators due to attention diversion.
In some pharmaceutical industries the use of cell phones is very common without any restriction but many have a strict control as well.
Miss Use Of Mask & Gloves
Mask & gloves are recommended during manufacturing operations for the safety of operators & products.
Here we have observed two types of violations regarding the use of mask & gloves which are given below,
Case 1
In some pharma industries the culture of using masks & gloves in manufacturing facilities is not common.Many individuals involved in various activities are not aware of wearing masks & gloves.
Case 2
In many pharma companies the workforce properly wears masks & gloves during manufacturing activities but they don’t remove them before leaving the area.They enter into any other area with same mask & gloves & come back to the native area with the same.It may result in cross contamination & is a wrong practice.
Data Integrity
Real time data entry of all documents in many pharma is not implemented.
The actual practice is to fill all documents at the same time when the activity is carried out but in routine it is not implemented.
The main reason is shortage of technical staff or lack of awareness.
Real time data entry must be ensured to comply with the data integrity guidelines of 21CFR.
Avoid PPEs
It is commonly observed that a major Portion of the workforce avoids the proper utilization of Personal Protective Equipment during risky operations.
There are two reasons one is unavailability of PPEs for everyone in many pharma & second is lack of safety awareness.
Wrong Use of Emergency Exit
The emergency door in any Pharmaceutical Industry must remain free of any obstacles so that it can be properly utilized during an emergency.
It is generally observed that emergency exits in many pharma industries are used for materials transportation, as a storage area or as a sitting area with chairs & table arrangement.
Ignorance Of Area Maintenance
It is generally observed that the majority of the individuals working in pharma don’t follow the procedures of cleanroom maintenance.
It can be violated in any of the following way
- Doors remain open during manufacturing operations.
- Discussions with others while keeping the door open.
- Bypassing the interlocking system.
- Use of material entrance for personal movement.
Conclusion
We tried to mention the most common mistakes as a general which are usually observed in the majority of pharma.
The main & basic reasons for all above mentioned mistakes is lack of knowledge & awareness.
Training sessions must be arranged along with awareness campaigns with proper monitoring & follow up.
Use of cosmetics, jewelry or makeup must be prohibited for all individuals entering into the manufacturing facility without any discrimination of designation.
Cell phones should not be allowed to the workforce which is directly involved in manufacturing.
Proper utilization of masks and gloves must be ensured.
Monitoring systems for data integrity should be implemented & ensure proper utilization of PPEs.
Emergency exits must remain free all the time & awareness for area maintenance should be provided.
Activity
Which of the above mentioned wrong practices is observed in your pharma?
You can give the answer in comments without mentioning the name of your pharma.