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Pharmaceutical regulations and standards

The manufacturing of pharmaceutical products has to be maintained at high standards to ensure the strength of the active ingredients, quality and purity of the final products. These standards ensure safe and effective products for patients. Minute changes in any of these factors can have serious consequences for patients, therefore the controls and checks put in place need to be far more stringent than, for example, the food industry.

The medical profession and patients expect medicines to be consistently produced to a high level of precision and safety with every new batch. But it is virtually impossible for the medical or pharmacy professional, much less the consumer, to tell if a pharmaceutical product as supplied by the manufacturer is safe, or if it contains what it is supposed to contain.

The major burden for ensuring consumer safety, lies firmly at the manufacturing stage, where it is essential to use industry-accepted Good Practices to maintain safety and efficacy.

Good practices for drug manufacturing

Both regulatory authorities and Pharmaceutical industry itself puts great emphasis on manufacturing pharmaceutical products using practices and processes that ensure high levels of quality and safety built into every step. Regulatory requirements emphasise Good Practices for controlling quality and safety, from drug development to distribution:

  • Drug discovery: Good Laboratory Practice;
  • Drug trials: Good Clinical Practice;
  • Manufacturer: Good Manufacturing Practice;
  • Distribution: Good Distribution Practice;
  • Storage: Good Storage Practice.

GMP is the part of quality management which ensures that products are consistently produced and controlled according to the quality standards appropriate to their intended use

WHO good manufacturing practices for pharmaceutical products - World Health Organization

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