By: Johanna Vallo
The process of manufacturing a drug substance involves several stages before it can be marketed and one area of such importance is the implementation of drug laboratory quality control. Standard operating procedures of drug manufacturing include quality check and quality assurance from the raw materials used to the finished products. It includes the checking of the specification standards of raw materials, packaging and labeling materials, and the random sampling of finished products.
Drug laboratory quality control is an assurance check that all drugs being manufacture pass quality standards set by different drug regulatory boards. Quality control is necessary in every phase of drug development. The most important purpose of quality control in drug manufacturing is to make sure that the public can avail of safe and therapeutically effective medicines.
The impact of poor drug laboratory quality control will be low quality drugs or below standard quality medicines. This can lead to:
Lack or minimal therapeutic effect – If drugs have not gone quality checks, the major consequence is that they cannot exert their maximum therapeutic effects. The active constituent content of the drug may be minimal or does not comply with the labeled claim of the drug.
Adverse or toxic effects may occur- The worst result of poor quality control can result to death because of the drugs adverse effects or toxicities brought about by poor aseptic techniques implemented in the production process.
Loss of credibility of the drug firm- Poor quality drug can backfire to the company that manufactured them. If drug laboratory quality control protocols are not followed, drug regulatory boards can order closure of the company.
