PHARMACEUTICAL QUALITY CONTROL ANALYSIS.

Like the food and beverage industries, that manufacture substances that enter the human body, the Pharmaceutical industry is designed to ensure that its products and processes meet certain, non-negotiable quality standards.

The pharmaceutical industry is even much more stringent as regards quality, because it manufactures products that can alter the normal physiological, psychological and mental functioning of the human body; and is also the only feed stream for the various fields of medicine.

Therefore, in the words of the CEO, Quality Chemical Industries Limited , Mr. Ajay Kumar Pal , in his remarks at the Safety week, 2024; "Quality and Safety are second to none", quality especially in the pharmaceutical field / industry is the utmost priority.

To meet the indispensable and non-negotiable objective and need for quality, several and rigorous quality control tests are carried out on all substances entering and leaving a pharmaceutical manufacturing process; notably the raw materials, packaging materials and the finished products. Further inspections are done on machinery and equipment used in the process.

The Quality Control tests being categorized into In-Process QC (IPQC) tests and Finished Products QC (FPQC) tests.

The IPQC tests are done during the production process; and is aimed at detecting and correcting errors at every stage of production. It is also aimed at monitoring and adjusting production parameters back to desired ranges, in case of any deviation(s).

FPQC tests are both quantitative and qualitative; and are done on Finished products, to ensure their compliance to the set, local and global quality standards. Quality Chemical Industries Limited adheres to both National Drug Authority (NDA) and World Health Organization 's standards.

Quality Chemical Industries Limited majorly produces Antiretroviral and anti-malarial drugs, as its contribution to the regional and global fight against the killer diseases: HIV/AIDS and malaria, endemic in Africa and other parts of the world.

Several FPQC tests carried out include: Identification test, Hardness/Break force test, Friability test, Disintegration test, Dissolution test, Assay, Uniformity of Dosage Units, Impurities determination; among others.

• Identification tests: confirm the presence of the right API's in the medicines, as per the Pharmacopoeias.
• Dissolution tests: determine how quickly the API's get released into a given media, representative of the human physiological medium.
• Assay tests: quantify each API in each tablet; in percentage form.
• Uniformity of Dosage Units (UDU): ensures each tablet contains the same, specified amount of each API. This ensures consistence in the dosage and hence therapeutic effect of each tablet.
• Impurities determination: identifies and quantifies any foreign and undesired substances in the medicines.

Several Analytical techniques are applied in the pharmaceutical qualitative and quantitative analysis ; most notably: Chromatography and Mass spectrometry.

Chromatography applies the difference in the interaction of the substance(s) in question (called an analyte(s)) with different phases (the mobile and stationary phases), to identify, quantify and separate different components of a mixture.

This difference, being due to the difference in the effective distribution / partition of the analyte(s) between the two phases; which in turn is due to factors like the chemical nature of the components, temperature and PH.

The common Chromatographic techniques used are: High Performance Liquid Chromatography (HPLC), Thin Layer Chromatography (TLC) and Gas Chromatography (GC).

Mass spectrometry makes the use of the charge-to-mass ratio, from which the molecular mass of the different components in the sample mixture are identified.

The samples and standards are prepared by preparators; using different analytical laboratory practices like weighing, dissolution, sonication, pipetting, dilution, further dilution; among others.

The samples and standards are then analyzed by the chromatographers and other analysts using the different analytical equipment.

Among the impurity identification tests are: Organic impurities, Related Substances and Elemental impurities tests.

The most recently adopted, on the advocacy by WHO; is the Elemental Impurities (E.I) test.

E.I, currently being done only at Quality Chemical Industries Limited , the only company licensed by WHO in the whole of Africa, is done to detect heavy, carcinogenic metals like mercury, gold, Thallium, Lead, Nickel, Arsenic; among others, from the medicines / tablets.

It involves the use of the very sophisticated and expensive Inductively-Coupled Plasma Mass Spectrometry (ICP-MS) technique.

This is response to the surge of cancer cases recorded among several patients, according to recent WHO findings.

All these, and many more others, is the concerted effort of the Quality Control (QC) and Quality Assurance (QA) departments; and portend the non yielding commitment of the pharmaceutical industry as a whole, and Quality Chemical Industries Limited , in particular, as such a company, to quality and safety; quality and safety of all its products, and safety of all its human resource and workforce.

Courtesy of:

Quality Chemical Industries Limited (QCil)

Ajay Kumar Pal , CEO - QCil.

World Health Organization (WHO) and partners.