Among the tools used by the Pharmaceutical Industry, Primary and Secondary Standards are often viewed as critical, as it is through these substances that the identification and dosage of all medicines are determined with certainty.
These substances, however, have different roles in pharmaceutical production: Primary reference standards are substances manufactured and tested to compliance by a certified source with high quality and supplied with respective Certificate of Analysis. Secondary reference standards are substances that are prepared by comparison with a primary reference substance. They can be provided by manufacturers, and they are also named as working standards.
The certified sources from which these quality reference standards can be obtained are British Pharmacopeia (BP), United States Pharmacopeia (USP), and European Pharmacopeia (EP) but they are quite expensive, which is why the Eudralex volume 4 refers, on chapter 6, that “Reference standards should be established as suitable for their intended use. Their qualification and certification as such should be clearly stated and documented.
Whenever compendial reference standards from an officially recognized source exist, these should preferably be used as primary reference standards unless fully justified. For example, the use of secondary standards is permitted once their traceability to primary standards has been demonstrated and is documented. These compendial materials should be used for the purpose described in the appropriate monograph unless otherwise authorized by the National Competent Authority.
In other words, Primary standards are used as primary calibrators or primary reference materials. They are purchased in very small quantities and would therefore be used for standardization and preparation of Secondary standards. From Primary Standards, Secondary Standards can be prepared in appropriate quantities. It should be ensured that the standards are, in the storage conditions described on the label and/or certificate of analysis. All analytical results obtained in the standardization shall be recorded in the laboratory according to GMP standards.
For these reasons, it is important to consider that, ultimately, it is possible to ensure correct work, as far as “Primary and Secondary reference Standards” with an elaborate and concrete SOP that addresses all calibration details, which, in turn, will help you to avoid any sanctions by the authorities. RC REDOL can be your partner in this journey since we provide the experience and know-how necessary for your organization to keep up to date with the regulations and to ensure correct quality management. Take the first step, today, and contact us!
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