Ensuring quality pharmaceutical products
Whilst embracing technology and upholding sustainability, pharmaceutical manufacturers still need to ensure their products are safe for consumers. The commitment to serve the people by providing quality and affordable healthcare would remain the top priority.
This is because ensuring healthy lives and promoting well-being at all ages is essential to sustainable development.
In doing so, these manufacturers might need external assistance like SIRIM to help them with the facilities, services and standard validation.
Dr Ahmad Hazri Ab Rashid, General Manager of SIRIM’s Industrial Biotechnology Research Centre (IBRC), said three different types of facilities at the centre might be helpful to pharmaceutical manufacturers in general.
“The first one is the analytical and testing facilities. The testing areas are in biological, chemical and physical analysis or testing. The biological analysis can be broken down further into toxicology, microbiology, molecular biology, biological assays. The chemical analysis and testing include chromatographic techniques (liquid and gas), mass spectrometry and titration techniques,” said Ahmad Hazri.
“The second one is in “open lab” collaboration where we invite the pharmaceutical companies to use our labs in collaborative work to perform research activities in the development of pharmaceutical processes and products, be they chemical or biological.
“The third one is our piloting facilities where the companies can use to optimise their process be they upstream or downstream processes and may also include the heart of the process, which is the reaction process.
“We invite the pharmaceutical companies to meet us and discuss how we can formulate solutions for challenges faced by the industry.”
Commitment to provide safe pharmaceutical products
IBRC is in a synergistic relationship with the local pharmaceutical manufacturers and committed to assisting pharmaceutical companies in manufacturing safe, modern drugs for consumers.
In ensuring the safety of these pharmaceutical products, Ahmad Hazri highlighted that the centre would perform the identification tests and the quantification and limit of impurities to ensure the product meets the required specifications and is free from any substances that affect the safety of the product.
“For example, nitrosamines are organic compounds that we are exposed to in our everyday lives. They are formed from chemical reactions or in low levels in our water and foods (meat, vegetables and dairy).
“Some nitrosamines may increase cancer risk if people are exposed to them above the acceptable levels and over long periods. At IBRC, we frequently performed the analysis for detection and quantification of nitrosamines for the pharmaceutical companies to meet regulatory requirements both locally and overseas.
“We are also able to perform toxicity and microbiology testing on production samples as part of quality controls or in development samples for registration purposes. Some examples of tests are abnormal toxicity, pyrogen test, sterility test and endotoxin test,” said Ahmad Hazri.
Validation of Active Pharmaceutical Ingredients
Besides providing safety assessment, IBRC also offers pharmaceutical manufacturers the service to validate their Active Pharmaceutical Ingredients (APIs).
APIs are the main ingredients in medicines, and due to the different manufacturers, these APIs might have other qualities and strengths. Therefore, the validation of APIs is essential for pharmaceutical companies to ensure quality healthcare products.
According to Ahmad Hazri, the determination of APIs are governed by the standards described in the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) or Food and Drug Administration (FDA). The determination can be performed on production samples or samples from R&D activities.
The general manager said: “The discussion of the validation of analytical procedures is directed to the most common types of analytical procedures.”
These types of procedures include:
• Identification tests to ensure the identity of API by comparison of a property of the API (e.g., spectrum, chromatographic behaviour, chemical reactivity, etc.) to that of a reference standard
• Quantitative tests or limit tests for control of impurities’ content
• Quantitative tests of the active moiety in samples of drug substance or drug product or other selected component(s) in the drug product
“At IBRC, we perform method validation of our analytical procedures to ensure our analysis meets the relevant standards applied by the relevant regulators. It includes the following validation parameters: analytical procedure, specificity, accuracy, precision, detection limit, quantitation limit, linearity, range and robustness.”
Ahmad Hazri then explained the meaning of each parameter involved in the validation process.
“The analytical procedure refers to the way of performing the analysis. Specificity is the ability to assess the analyte unequivocally in the presence of components expected to be present.
“The accuracy of an analytical procedure expresses the closeness of agreement between the value which is accepted either as an actual conventional value or an accepted reference value and the value found.
“The precision of an analytical procedure expresses the closeness of agreement (degree of scatter) between a series of measurements obtained from multiple sampling of the same homogeneous sample under the prescribed condition,” said Ahmad Hazri.
He then mentioned that the precision might be considered at three levels: repeatability, intermediate precision and reproducibility.
“The detection limit of an individual analytical procedure is the lowest amount of analyte in a sample which can be detected but not necessarily quantitated as an exact value.
“The quantitation limit of an individual analytical procedure is the lowest amount of analyte in a sample which can be quantitatively determined with suitable precision and accuracy.”
He explained the linearity of an analytical procedure referred to its ability (within a given range) to obtain test results directly proportional to the concentration (amount) of analyte in the sample.
Meanwhile, the range is the interval between the upper and lower concentration (amounts) of analyte in the sample (including these concentrations).
“Finally, the robustness of an analytical procedure is a measure of its capacity to remain unaffected by small, but deliberate variations in method parameters and provides an indication of its reliability during normal usage.”
SIRIM’s IBRC is home to the nation’s premier industrial biotechnology R&D and technical service provider. The centre offers a wide range of product testings to fulfil industry’s demands for safe, high-quality products that comply with regulatory requirements. — @green