Requirements and Implementation of Continuous Training in Pharmaceuticals : Pharmaceutical Guidelines

Requirements and Implementation of Continuous Training in Pharmaceuticals

Training is important but continuous training is more important because workers must be aware about the current change in the pharmaceutical regulatory guidelines to work accordingly.
Training is crucial in almost every field. In pharmaceutical industry it is of great importance as a slight difference in the composition of a drug can cause huge effects on a person or even cause death. It takes years of hard work to develop a drug formula. Getting the drug approved by FDA and other decision-making committee is not an easy job.

With very little carelessness in the product quality, it is very common to find FDA warning letters and various notices or violation letters. In 2017 there were 61 GMP warning letters issued by FDA related to data deficiency and improper handling issues. 30% of these 61 GMP warning indicated towards training issues or requirements. Big pharmaceutical companies face huge loss due to unskilled labor or accidents due to careless handling of machinery. Production of a wrong batch of medicines will greatly stain the reputation of the pharmaceutical company.

Consequences of Improper or Lack of Training
Continuous Training
One has to deal with many complicated processes before a medicine is released in the market. Employees working in granulation, compression, coating, quality control and warehouse are some of the areas those need proper training of the staffs. Additional knowledge in more than one department of an industry such as quality control, warehouse, and packaging, should be provided. Workers also need to be given proper training to maintain their proper hygiene. In sterile pharmaceutical manufacturing, many issues of product sterility are reported due to the lack of personal hygiene.

There are many accidents reported due to improper management of machinery. Sometimes these incidents can be fatal. For example, in the year 2012, there was a fatal explosion at one of the Canadian pharmaceutical plant. Due to improper handling, there was a fire which went on to destroy 15,000 liters of acetone. Two workers were declared dead on the site and twenty were brought to the hospital. A blast in FBD was reported in a reputed Indian pharmaceutical company in 2011. One operator died in this accident.

Another important issue is drug storage. Drug products that have to be subjected to proper storage conditions (including proper temperature requirements, humidity, pressure, age and preventing them from smoke, fumes, or radiation). Improper handling of the raw material in warehouse area can cause the issuance of wrong material that can damage the whole batch. This can cause the ten times more loss of revenue of the company than the cost of staff and workers training.

The requirement of Continuous Training in Pharmaceuticals
Pharmaceutical companies are required to follow the cGMP guidelines. cGMP is a continuous process of improvement of manufacturing practices. Regulatory agencies are continuously making amendments to the guidelines. If companies need to comply with the regulatory agencies then they have to train our employees accordingly. Continuous training should not be limited to the amendments of the regulatory guidelines but employees must be trained for changes in the SOPs, validation programmes and new equipment or system.
Related: Requirements of FDA for Training in Pharmaceuticals

How to Implement it into the Pharmaceutical Industry?
Methodologies like Lean Six Sigma are a means of promoting continuous improvement. There are various approaches to train workers. One of the best approaches is internal training. According to this method, the industry needs to hire experts and these experts train the workers. The next approach will be arranging the classes where works can learn before getting their hands on the machinery. This will allow them to know about the machinery and clear their doubts related to the working.

Other than these, a continuous evaluation of workers helps in keeping a check on the improvement of the worker. This clearly tells the worker how bad or good they are. Giving continuous feedback plays a major role here. If the employees get continuous feedback from their employers, this two-way process encourages them to work harder and better. Companies should always invest in workers development. This produces the employees who take pride in their work and are happy with their work making sure that there is continuous progress in their knowledge.
Related: Common Ways to Avoid the Most Frequent GMP Errors

Training of employees should be a continuous process. Companies can hire contractors that can train their employees in the workplace or before they are set on with the responsibility of handling big complex pieces of machinery.

Successful companies have always focused on training as an ongoing process and not as an individual event. This is simply based on the fact that the more you learn more you earn but most of the companies don't want to invest in training and they have an employee to maintain the training documents with his routine work. I would recommend having a training and implementation team in pharmaceutical companies that will find and implement the cGMP requirements and arrange training of the employees accordingly.





Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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