The Importance of Good Manufacturing Practice (GMP)

When we take a couple of painkillers or give our child a spoonful of cough syrup, we do so in the firm belief that the medicine will do what it is supposed to do and not do any harm. We believe this because we trust that in our modern society the knowledge, standards and practices are in place to ensure our medicines are safe and effective.

Regulations have been introduced as a response to tragic circumstances from our past and to prevent them from happening again. Laws concerning the production of medicines are in place worldwide, to protect the patient.

However, as reported in the news today, executives at a pharmaceutical manufacturer in Indonesia have been prosecuted after a failure with tragic parallels to the Sulfanilamide Disaster in 1937.

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Boss of Indonesia cough syrup maker jailed after child deaths

The Chief Executive and three other officials of an Indonesian firm whose cough syrup was linked to the deaths of over 200 children have been sentenced to jail.

They were handed two-year prison sentences and fined 1bn Indonesian rupiah ($63,056; £51,786).

The firm, Afi Farma, was accused of producing cough syrups containing excess amounts of toxic substances.

The Public Prosecutor said that between October 2021 and February 2022 the company received two batches of propylene glycol, which is used for making cough syrup.

These batches contained 96% to 99% ethylene glycol, the prosecutor said. Both substances can be used as additives to solvents. While propylene glycol is non-toxic and widely used in medicines, cosmetics and food, ethylene glycol is toxic and used in paint, pens and brake fluid.

The company did not test the ingredients used in the cough syrup and instead relied on quality and safety certificates from its supplier, prosecutors said.

Source: BBC News 2nd November 2023

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The Sulfanilamide Disaster

Sulpha (Sulfa) drugs were introduced in 1935 and many manufacturers began making the new anti-infectives as drugs used to treat streptococcal infections. In 1937, S. E. Massengill Company, a pharmaceutical manufacturer, experimented with a liquid preparation of Sulfanilamide. Harold Watkins, the company’s chief pharmacist and chemist, found that it would dissolve in diethylene glycol (DEG) and called the preparation “Elixir Sulfanilamide”.

But Watkins was not aware DEG is poisonous to humans (it is a chemical analogue of antifreeze). He simply added raspberry flavouring to the sulpha drug which he had dissolved in DEG. The company marketed the resulting “elixir” resulting in at least 358 poisonings and 107 deaths, mostly of children.

Lessons still to be learnt

The pharmaceutical industry is one of the most heavily regulated industries in the world because, as we have seen although medicines have the power to do good, they also have the potential to do great harm if not prepared correctly.

Good Manufacturing Process (GMP) is the practice which ensures that products are consistently produced to the quality standards appropriate for their intended use and as required by the product licence.

However, even in this modern day of extensive regulations and legislation controlling the manufacture and supply of medicines, as we have seen today new disasters and issues are waiting to happen. This triggers new questions on how we need to assure quality, safety and efficacy.

So, what can we do?

We must strive to ensure we adhere to GMP. This can only be achieved by having robust and validated processes, supported by good procedures and effective training. The key point to note is that GMP is not a once off. We constantly need to review, assess and improve our practices to ensure we remain compliant and avoid such outcomes as we have seen today.

If you need any support with ensuing this ongoing compliance including support with self-inspections, audits, gap assessments or inspection preparation/remediation please reach out to the team here at JensonR+.

Our Quality team, which includes Qualified Persons and Responsible Persons, are highly experienced in the pharmaceutical industry with a proven track record of consistent delivery. In addition we have experts in Regulatory Affairs and Pharmacovigilance including QPPVs.
Contact us to find out how we can support and deliver your GxP needs.