Common confusions on the supply chain
Richard Moreton, vice president of pharmaceutical science at FinnBrit Consulting, covered the topic as part of his speech on ensuring the integrity of the supply chain.
Moreton believes that companies and individuals, especially outside of the US, have some misconceptions about product quality and supply chain integrity.
One of these common misunderstandings is that compliance with the monograph is sufficient. If this was true it would be acceptable to label technical grade material as compendial if it conforms with the latter’s monograph.
Moreton stressed he believes that this practice is unacceptable and stated his belief that adherence to good manufacturing practice (GMP) is vital to ensure product quality.
Companies should have knowledge of the conditions in which their materials were manufactured, according to Moreton, who used a colourful analogy to illustrate his point.
Moreton said: “You go into the restroom, you need a toothbrush, you find one on the floor. Would you use it? Seriously, would you use it? You can test the hell out of it but would you use it?
“No because you don’t know where it’s been. It might be clean; there might be no microbial contamination; there might be no chemical things you can detect but it’s not a good way to find a toothbrush, even if you’re desperate for a toothbrush.”
The emphasis on ensuring GMP is adhered to is necessary according to Moreton as: “No amount of testing will prevent fraud, only detect fraud.”
He also claimed that after he and his colleagues took a thorough look through documents provided by pharmacopeias from around the world only the US detailed compliance with GMP as a necessity.
Moreton was not questioning the quality of the other pharmacopeias, in particular saying the EU was a fine and respected body, but did express surprise that he was unable to locate any information on GMP compliance being essential.
