Maintaining safety and adhering to the highest standards of hygiene is the topmost priority at a drug manufacturing plant. A drug impurity is something that is not a regular component of the drug’s formulation.
In drug manufacturing plants, there are several chances of contamination. The contaminant can be an organic substance. These substances can arise at multiple steps during the manufacturing process.
So they can be a by-product of the synthesis or an intermediate compound, or a product of drug degradation.
The contaminants can be inorganic substances like ligands, heavy metals, etc. The presence of impurities in drugs can cause severe health concerns. So all drug manufacturing plants practice good manufacturing norms to ensure that their products are safe for human consumption.
Ways In Which Drug Manufacturing Plants Maintain The Purity Of Their Products
Maintaining the purity of drugs is a core concern of drug manufacturers. All jurisdictions in the world have stringent norms and standards for drug safety. In the US, for instance, the FDA( Food And Drug Administration) clearly defines what drug purification means, and any drug which does not meet the safety norms is not allowed in the market.
Using Equipment That Reduces Chances Of Contamination
A drug manufacturing unit needs several pieces of equipment like a tablet counter, a
liquid capsule filling machine, a powder filling machine, a conveyor belt, etc. Each of these pieces of equipment increases the efficiency of production, and they also reduce the chances of contamination.
One major advantage of pieces of equipment is that they minimize human contact with the final product(drug). As the chances of human intervention are reduced, the chances of accidental contamination are reduced. A machine also protects the worker from accidental exposure to powders and solvents that can cause harm.
A liquid capsule filling machine, for instance, is almost a necessity for all plants that manufacture capsules. Some drug formulations need to be sold in semi-solid form due to their poor solubility. For such formulations, a liquid capsule filling machine is indispensable.
Most capsule filling machines are automated, and they are highly efficient. Some machines are known to fill and seal almost 1200 per hour. The design of filling and selling is such that the machines can be thoroughly cleaned after each round of production. Easy cleanability is a great advantage because residual chemicals can upset the composition of capsules in the next batch of production.
Performing Risk Assessments
Risk assessments are a precautionary measure to assess what harms exist or what hazards may occur at a place, and then steps are taken to minimize those hazards. Risk assessment involves several components, and the risks are assessed at the following levels.
- Planning and Product level risk assessment
- Risk at the premises-these usually includes the risk of fires, escape of chemicals, etc.
- Risk to people-this involves gauging the adequacy of the safety equipment and safety
norms in a workplace. So it involves checking if the personnel have safety gear like face masks and gloves. Do they know how and when to use the equipment?
- Prevention and Protection risk-This involves checking if the safety norms are in place. So if the fire does not function or the safety valves of a machine are not working, it is a protection and prevention risk.
- Policy risk- This involves assessing the broad policies in all areas to see if they encourage safe practices.
Maintaining Data Sheets
A datasheet or a safety data sheet, as it is commonly known, is a sheet that provides information on the properties of chemicals. Every chemical has definite chemical and physical properties.
A datasheet contains information on the chemical and physical properties of the material. So when you purchase a new chemical compound for your drug manufacturing unit, you get a sheet that mentions its dielectric constant, chemical composition, melting points, etc.
Properties like melting point and chemical reactivity are vital as they determine the outcome of chemical reactions involved in the manufacturing process. So every time a new drug formulation is being tested or a new person is involved in the production process, the data sheets must be exchanged.
Datasheets help take adequate safety measures, and well-maintained datasheets go a long way in preventing accidents in a manufacturing unit. Well-maintained and up-to-date datasheets ensure that vital information is not lost in translation.
Ensuring The the Products Conform To The Environmental Safety Norms
A drug manufacturing unit, like any production unit, has to conform to environmental standards. There are many environmental concerns in a pharmaceutical unit, like the discharge of effluents, the release of chemicals, the type of packaging used, etc. Of these, the release of effluents is a significant concern.
Globally the world has started seeing the harmful impact of antimicrobial resistance or AMR. The World Health Organization (WHO) says that AMR undermines the effectiveness of modern medicines and puts millions of lives at risk.
AMR means that increased and improper use of antibiotics makes the bacteria (microbes) resistant to the drugs.
When drug manufacturing units release effluents from an antibiotic manufacturing unit, they may induce antibiotic resistance in microbes by the improper release of antibiotics in the environment.
Thus, a responsible drug manufacturing unit should treat its effluents properly so that they do not cause hazards like antimicrobial resistance. Likewise, the packaging should use a little plastic if possible. Since plastics are known to cause long-term harm to the environment, replacements for plastic covers are sought by responsible drug manufacturers.
Drug manufacturers follow many safety practices at all stages of production to ensure that the production process and the product itself do no harm. Moreover, manufacturers also take care of the safety of the people who work in their units.
The WHO has a comprehensive list of GMPs or good manufacturing practices for pharmaceuticals. These GMPs cover all aspects of drug production, like the drug manufacturing process, analytical methods, water treatment, computer system validation, etc.
All responsible manufacturers adhere to the GMPs given out by WHO and other global regulatory bodies so that their products gain maximum acceptability.