Pharma companies are governed by defined rules and regulations to ensure efficiency, quality and safety in their products in global markets.
If we talk about compliances, requirements evolve and from time-to-time, new products are tapped into at a quick pace. Parenteral Drug Association (PDA) has researched that on an average, a pharma company must manage 1250 compliance GMP-related Standard Operating Procedures (SOPs).
SOPs are well-written methods that describe all the necessary tasks and procedures in detail regarding the pharmaceutical ‘context’; they document a routine activity and employees must follow them. People in this industry who are especially engaged in R&D, manufacturing, processing, packaging and holding drug products are trained, educated to perform those functions. But knowing and understanding SOP is one thing and complying with cGMP requirements is a different proposition. Pharma companies have numerous SOPs, which are conducted on a routine basis – each task requires an SOP that has to be often updated.
SOPs serve the purpose of – superior, consistent, compliant and reproducible job execution-in line with the enforced drug standards (FDA, CDSCO or MHRA).
To help achieve the above, trainings are essential and in an industry, is a continuous process. Plus as new trends prevail, companies grapple with many challenges. Primary among them can be:
- Their expanding footprint across the globe
- Faster launch of new products
- Keeping updated with the changing regulatory compliances
- Budgetary aspects for organization-wide trainings
How E-learnings help industries tackle SOP-related concerns
E-learnings help promote learnings in an environment where numerous repetitive tasks are involved. Their primary delivery method – enhanced learnings through interactive media and assessments post learning, forms a complete package for a high-risk industry such as pharmaceutical. Because here, a keen emphasis on standards is given to deal better with hazards and risks to maintain a safe workplace.
It is often said that a worker learns better ‘by doing’ as they come across various scenarios for themselves. For such cases, considering repetitive trainings is not wise; it isn’t cost-effective to the industry. E-learnings usually provide continual improvement related to specific processes. Their packages also allow flexible scheduling of time and the curricula can be designed to be specific and relevant to a learner’s roles and their responsibilities.
Cognitive skills that comprise technical know-how, procedural skills and developing thinking ability form a part of the E-learning vocabulary. By presenting different scenarios, either with photos or through videos, a learner is introduced to different learning styles. For SOP, this becomes necessary as going through the same set of documents becomes dull and to help sustain learner’s attention, a taste of text, audio, video, images can be useful.
When n number of people are a part of an SOP, eg. For handling spillages, E-learnings can better address such situations because they provide more clarity (e.g. the type of personnel involved or approach to while handling spillages in this case). They can offer instructional methods in a clear and crisp manner; ensure that same quality of information is received by every learner, thus enabling efficacy.
E-learnings can be ideal when people are geographically dispersed and have limited time at their disposal. If a specific group of people are to be trained for a certain topic; say procedure to sterilize a drug container, E-learnings convey the right amount of background knowledge.
All of this is nothing but an aid of technology to lay better light on compliance and trainings. E-Learning chronicles the best knowledge and can complement conventional and standardized trainings for those who are new to the job or need retraining. It is a systematic solution that keeps the ethos of trainings intact and deftly handles the challenges in this industry. We are now aware that SOPs are integral to a pharma industry, so leveraging traits of technology for this purpose makes sense.