Welcome to our new home!

Enquire Now

Call us today on 0333 939 0034

Put the kettle on.

Close

How can we help make your day better?

    Quality Control

    A process by which a given entity reviews the quality of all factors involved in production of a given drug, product or compound.

    PTL Boffins - Job Role

    Quality control in the pharmaceutical industry is a critical aspect of ensuring the safety, efficacy, and quality of pharmaceutical products. This sector is highly regulated, and the stakes are extremely high due to the direct impact on public health. Quality control (QC) encompasses a range of activities and processes designed to verify that pharmaceutical products meet the required standards and specifications.

    Quality Control in the Pharmaceutical Industry

    Features of good quality control within the pharmaceutical industry include:

    Regulatory Compliance

    Pharmaceutical companies must comply with a variety of regulations and guidelines, such as those set by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Compliance ensures that products are safe, effective, and of high quality.

    Good Manufacturing Practices (GMP)

    GMP are the practices required in order to conform to guidelines recommended by agencies that control authorization and licensing for the manufacture and sale of pharmaceutical products. These guidelines provide minimum requirements that a manufacturer must meet to ensure products are of high quality and do not pose any risk to the consumer.

    Raw Material Testing

    All raw materials used in the manufacture of pharmaceutical products must be tested for quality and purity before use. This includes active pharmaceutical ingredients (APIs), excipients, and other additives.

    In-Process Quality Control (IPQC)

    During manufacturing, various quality control tests are conducted to ensure that the process is controlled and consistent. This may include monitoring and adjusting environmental conditions like temperature and humidity, and testing intermediate products for quality parameters.

    Final Product Testing

    Before any pharmaceutical product is released to the market, it must undergo rigorous testing. This includes physical and chemical testing, biological testing, and microbiological testing to ensure that it meets the required specifications.

    Validation and Qualification

    Validation of processes and equipment ensures that they consistently produce a product meeting its predetermined specifications and quality attributes. Equipment and processes must be qualified and validated according to international standards.

    Documentation and Record Keeping

    Maintaining comprehensive records is a critical aspect of pharmaceutical quality control. Documentation includes records of all testing procedures, manufacturing processes, and quality tests, as well as reports on any deviations or anomalies and their corresponding corrective actions.

    Stability Testing

    This is used to ensure that a pharmaceutical product maintains its intended physical, chemical, and microbiological quality, as well as efficacy and safety, throughout its shelf-life.

    Handling Complaints and Recalls

    Effective systems must be in place for handling customer complaints and product recalls. Analyzing these incidents can provide insights into potential quality issues and areas for improvement.

    Challenges and Trends

    The pharmaceutical industry faces challenges like evolving regulations, global supply chain complexities, and the need for rapid development and deployment of new drugs, especially in situations like pandemic response.

    Trends include the increasing use of data analytics and artificial intelligence for process optimization, predictive maintenance of equipment, and enhanced decision-making in quality control.

    Conclusion

    Quality control in the pharmaceutical industry is essential for ensuring that the products released to the market are safe and effective. It requires a meticulous, well-documented approach that covers every aspect of the drug development and manufacturing process. By adhering to strict regulatory standards and employing rigorous quality control measures, pharmaceutical companies can protect public health while maintaining the trust and confidence of consumers and regulatory authorities.

    Our validation gaskets can help your business implement strong quality control practices through In-Process Quality Control (IPQC).

    Join our inbox fan club

    We’ll update you on gasket stuff. It’ll change your life, honestly!

    PTL / News

    Pure Transfer curve