Healing is a fundamental need and from time immemorial, people have used plants and natural remedies to recover from their illnesses. These uses, together with advances in chemistry and technology, gave rise in the 19th century to the pharmaceutical industry and, today, to a continuously growing market that exceeds 1,200 billion dollars.
In order to ensure consumer safety, the sector is one of the most regulated in terms of research, production, and distribution. In this area, CMMS is an essential link
in enabling pharmaceutical companies to comply with standards and optimize their production capacities.
The pharmaceutical industry, evolution, and regulation
An Industry in constant search of innovation
It is a fact that men have always been attentive to their health, and this since the beginning of their existence. Indeed, before the use of chemical molecules as is the case now, each culture had its own mixtures and practices to cure ills. We can take the example of traditional Chinese medicine, which is still widely used today.
Over time, thanks to advances in chemistry and the appearance of factories, researchers and testers have developed increasingly innovative and effective remedies. These new medicines have made a major contribution to extending and improving life expectancy. However, the slightest problem or defect in the manufacturing process can be dangerous or even fatal for the patient. In order to avoid this, governments and health organizations have decided to strictly regulate the drug development process up to the point of distribution.
This constant search for innovation is, of course, still relevant today. Researchers are constantly creating, improving or rethinking recipes, processes, and technology while minimizing costs. At the international level, the harmonization of requirements for the rules applicable to the industry is still being finalized and is the main challenge.
Standards and Compliance
As mentioned above, to meet the heavy responsibility for consumer safety, strict standards have been established. They guarantee the potency of the active ingredients and the quality of the finished products.
The slightest transgression of these standards can have serious consequences for the patient. Neither the consumer, nor a health care professional, nor a pharmacist can know whether the product is safe because it is impossible to determine with the naked eye. This is why more rigorous controls and checks are regularly carried out than those applied in other industries.
These regulations may differ from country to country. As far as the European Union is concerned, manufacturers and importers must be authorized, registered and verified by the competent authorities.
In addition to the legal and regulatory requirements, additional standards (mainly food) codify the manufacture of medicines:
- SQF (Safe Quality Control)
- BRC (British Retail Consortium)
- ISO 22000
- HACCP (Codex Alimentarius)
- Prime Safe
- American Institute of Baking (AIB)
They are also accompanied by the Good Manufacturing Practices established by the World Health Organization.
Monitoring the manufacturing processes
According to the World Health Organization (WHO), Good Manufacturing Practices (GMP): "are part of quality management. They thus ensure that products are consistently manufactured and controlled to the highest quality standards appropriate to their intended use, and as required by the marketing use, clinical trial authorization or product designation" (WHO, 2011). The pharmaceutical industry is at the highest level of quality assurance in the development, manufacture, and control of products. GMP-GMP is a concept of quality assurance. Each box of medicines placed on the market has been evaluated, tested and verified throughout its design to ensure compliance with regulations. These good manufacturing practices focus on all aspects of the process and control:
- Manufacturing process determined upstream and critical steps validated
- Suitable premises, storage, and transfer
- Trained and qualified production and quality control personnel
- Written and approved facilities and operating procedures
- Complete traceability of a product
- Claims registration and review systems
- An internal audit system to verify the implementation and monitoring of GMPs
- Hygiene and Sanitation
Standards for the drug manufacturing process are fine, but what about the equipment that makes them?
The essential contribution of CMMS
In the pharmaceutical industry sector, standards for premises and equipment are defined in Chapter 3 of the GMPs listed by the French Agency for the Sanitary Safety of Health Products (AFSSAPS) and are just as essential as the GMPs. Indeed, the production of medicines cannot take place without adequate working conditions. These include the well-being and hygiene of the personnel, the maintenance of the premises (pipes, ventilation, etc.), but mainly by the good working order of the production machines. The monitoring and maintenance of the equipment is therefore essential
and strictly regulated.
Before any intervention, the maintenance service provider must prepare a work order containing the following information :
- Name of the equipment concerned
- The description of the work to be done
- The name of the intervention
- The signature of the user service authorizing the action
Then, at the end of this one, the work order must be completed by presenting :
- The description of the work performed
- Any changes made
- The products used
- Parts that have been replaced
These documents must then be presented to the maintenance manager so that he can verify the accuracy of the information and sign it, and then the user service manager and quality assurance approve it for the equipment to be put back into service. Of course, many tests have been carried out according to procedures drawn up in advance by the maintenance department. All necessary parameters such as test frequency or acceptance limits are specified in these procedures.
Maintenance service providers are thus confronted with requirements that include a mass of information. There are many regulations to be complied with, and a maintenance strategy to be planned, which can sometimes be difficult to achieve without a suitable Computer-Aided Maintenance Management tool.
With CMMS it is possible to pre-register these formalities in the application and access them at any time thanks to its availability on a smartphone. Technicians can thus directly enter their work orders while on the move in front of the equipment as they carry out their maintenance. These work orders are immediately accessible by their manager and recorded in the centralized database, guaranteeing speed, traceability and data quality.
All procedures and rules are listed in the service ranges, shared and accessible by all, allowing maintenance providers to take a look at them at the slightest doubt and thus avoid errors.
In addition, access to an equipment history and intervention planning enables a preventive maintenance strategy to be established and the number of breakdowns to be reduced. This will increase the life expectancy of the installations while reducing maintenance costs, resulting in cost reduction and productivity gains.
CMMS software also offers a customization function that responds to the specific demands of its customers. An option that is perfectly suited to a sector that is constantly evolving.
The societal issues encountered recently suggest that the pharmaceutical industry will once again have to meet new challenges related to the ecological transition in order to move towards sustainable chemistry. It is time for these players to equip themselves with a modern CMMS solution capable of meeting these new challenges.
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