Melbourn Scientific is warning device developers and others not to rely on the accuracy of manufacturers specifications for raw materials as there can be major variations between batches. Derek Solomon, Laboratory Manager, comments that suppliers often only do a fraction of their business with pharmaceutical companies and their boundaries are often much wider than is acceptable for GMP manufacture.
Melbourn Scientific provides pharmacopeial testing as part of its suite of contract analysis services. The company has recently gained a manufacturing licence following a successful UK MHRA GMP (Good Manufacturing Practices) audit and is expanding its facilities for raw material testing, QC and finished product testing.
Solomon warns that raw materials testing is needed at all stages of development.
“Often the raw materials used in early product development are not GMP compliant with the assumption that they will be substituted for GMP grade material as the manufacture is scaled-up. This means that the raw materials are often not given much attention until later in the development process where the implications of impurity content are more costly.
“Pharmaceutical materials manufactured under GMP compliant conditions will be done in such a way that the product and the process are controlled and reproducible. It is not safe to assume, however, that the excipients will be produced in the same way.
“For many raw product suppliers their products are available in bulk to a range of industries and the specification can be changed without warning. This can have major implications for pharmaceuticals and may cause the final product to fail.”
The issue here is that there are no universal standards for commercial manufacturers outside of the pharma industry, and where testing does occur there is a requirement to transfer and validate the method in a GMP environment. Solomon advises that instead of relying on the manufacturers certificate of analysis, pharmaceutical product and device manufacturers should develop their own specifications and test against these.
“Testing requirements for the same product differ from pharmacopoeia to pharmacopoiea, however many suppliers are unaware of this and claim compatibility with both,” he explains.
“As experienced analytical chemists we are used to trouble shooting such issues and can assist clients by developing a detailed specification for the material which we can test against. This can include the correct pharmacopoeia for each of their target markets. We have found that raw materials can vary considerably and that regular testing can avoid costly recalls.”
Although a state-of-the-art analytical facility, Melbourn Scientific regularly performs some of the more historical requirements of the pharmacopoeia.
Regulation of medicinal products in the United Kingdom dates back to the reign of King Henry VIII (1491–1547) when the Royal College of Physicians of London had the power to inspect apothecaries’ products in the London area and to destroy defective stock. The current edition of the British Pharmacopoeia comprises six volumes which contain nearly 3,000 monographs for drug substances, excipients and formulated preparation.
“The older pharmacopoeia monographs can utilise the more classical chemical techniques which we can bring into the current century and implement the tests using more robust and commercially scalable analytical techniques,” continues Solomon.
“The importance of high quality raw material testing cannot be underestimated and should form a vital part in any product development lifecycle.”