Page 4 - Automated issue 14 - Maintenance matters

ISSUE 14
Pharmaceutical manufacturing now, then and in between
The influences that caused the pharmaceutical manufacturing sector to develop into what it is today.
Since the dawn of humanity, there have been people dedicated to healing others. Rituals, acupuncture and prayer were used in ancient times to treat patients, with herbs and plants used as early medicines. The production of pharmaceuticals has been revolutionised since the era of apothecaries.
Pharmaceutical manufacturing operates under a different set of pressures to other manufacturing industries. Because an error can have a detrimental impact on patients, the industry must be highly regulated. The introduction of new regulations has led to changes in the way products are manufactured, which has set the pharmaceutical manufacturing industry apart from other production industries.
Fordism
In the early 20th century, Henry Ford conceptualised Fordism as a method to increase productivity and standardisation in the automotive manufacturing industry.
One of the main principles of Fordism was to use standardised procedures to manufacture identical replicates. The concept also involved specialised assembly lines so that unskilled workers could contribute to production. Improved assembly lines reduced the manpower required to operate a factory, meaning employers could pay their workers a higher salary. In addition, the assembly lines used interchangeable parts so that they could be used to manufacture different products, giving rise to the idea of flexibility in manufacturing.
Fordism was later adopted by other industries, such as the pharmaceutical industry, which required standardised products to be produced accurately. This alone, however, was not enough to ensure patient safety.
The thalidomide scandal
In 1956, thalidomide, an anticonvulsive drug, was licensed as an over-the-counter medicine. The drug relieved morning sickness and so became popular with pregnant women. Thalidomide’s impact during
pregnancy led to the birth of over 10,000 physically impaired children.
The tragedy highlighted the need for rigorous testing of the safety of pharmaceutical products. As a result, the first European Pharmaceutical Directive was introduced. The Directive required all products to be authorised by a competent authority from at least one EU member state, prior to marketing.
“Transitioning from batch to continuous manufacturing reduces downtime, waste production and the need to reboot systems”
To gain authorisation, manufacturers had to prove that their drug was safe and effective. They accomplished this by altering their processes to reduce the risk of events that could make a product unsafe or ineffective. Companies also introduced research and development (R&D) programmes to analyse sample drugs post-manufacture.
Good manufacturing practices
In 1978, to further ensure the safety and effectiveness of pharmaceutical products, the industry established good manufacturing practices (GMPs). In accordance with GMP regulations, all products must be of consistent quality, be appropriate for their intended use and meet the requirements of the market authorisation or product specification.
The GMP compliance of pharmaceutical manufacturers is regularly inspected by the Medicines and Healthcare Products Regulatory Agency (MHRA) and the European Medicines Agency (EMA). The introduction of GMPs incentivised pharmaceutical manufacturers to examine their processes and make changes to ensure compliance.
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