Pharmaceutical Quality Control


What is pharmaceutical QC?

The term quality control when in reference to pharmaceutical manufacture refers to a selection of procedures that ensure the identity and purity of a particular manufactured product. Pharmaceutical identification (ID) test include methods such as thin-layer chromatography (TLC) which is a simple screening method for a particular pharmaceutical compound. TLC is used regularly in laboratories for the identification of counterfeit medicines.

Pharmaceutical analysis also includes significantly more complicated methods such as pharmacopoeial methods. The pharmacopoeia is a publication that lists directions for analysis (monographs) of a wide range of medicinal products. Analytical methods referenced involve the use of sophisticated laboratory equipment such as high performance liquid chromatography (HPLC). This technique is used to separate and quantify each component in a pharmaceutical compound or mixture

The final product of a suite of analytical tests and the ultimate deliverable of any quality control laboratory on the pharmaceutical industry is the development of a certificate of analysis (COA) for the products tested. A COA is a document that confirms the product including excipients and demonstrated that the product has been manufactured to the correct specifications and to good manufacturing (GMP) standards. GMP standards are enforced by the Medicines and Healthcare Regulatory Authority (MHRA), a government agency responsible for the regulation of medicines in the UK. To find out more, please visit the MHRA website.

What makes a good Quality Control Analyst?

To pursue a career in pharmaceutical quality control, it is essential that you have good attention to detail and that you can follow instructions. Standard operating procedures (SOPs) within a GMP laboratory require strict adherence to ensure that pharmaceutical products released on the market for sale are safe for human consumption. In addition, pharmaceutical QC laboratories are generally very fast-paced environments in which to work, especially in commercial laboratories or contract research organisations (CROs). Once a product has been manufactured, it has to be stored at expense prior to release for sale. In some cases, certainly with generic medicines, profit margins can be low, therefore every second counts. You must be able to remain calm under pressure and ideally thrive in high-pressure situations.

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