Quality Control - How are the controllers controlled?

Are there specific requirements for the analytical control laboratories controlling the manufacturing departments of medicinal products: in example active ingredients and finished products?


In short, yes there are!


Not only the manufacturing sites are comprised by finished product assessment of all relevant factors,  such as production conditions, results of in-process testing, reviews of manufacturing and packaging documentation, compliance with Finished Product Specification and examination of the final finished pack. Also the control laboratory premises and equipment shall meet the general and specific requirements for Quality Control areas specified in the rules for Good Manufacturing Practice – called “the GMP rules” in everyday speech and laid down in the European rules¹ as well as in the Danish rules².

There are requirements for e.g. design of physical facilities (cleaning, protection against insects or other animals, lighting, temperature, humidity and ventilation, avoidance of cross-contaminations), for the accurate function of the equipment and for the education, experience and authorization of the personnel.

In addition, all activities should be recorded and documented according to the official guidelines and internal documentation systems with written procedures for sampling, documentation and verification.

Instructions and written procedures for calibrations, qualification and maintenance of the analytical equipment (log books) and all kinds of methods must be validated in order to be able to secure and document that equipment always measures correctly and the analytical procedures are in compliance with final valid results.

Finally, all analytical results for equipment, substances and products are recorded in log books so that these abnormal results relative to trend analysis and specification requirements can be monitored to ensure that procedures and equipment are always in compliance with the specifications.

Control as a topic is to check the production processes for incoming materials and manufactured products to ensure that these particular procedures have just been followed, and therefore the laboratories of course must also keep control of their own processes and equipment.

¹ The Rules Governing Medicinal Products in the European Union, volume 4, EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary use.

² Bekendtgørelse om fremstilling og indførsel af lægemidler og mellemprodukter (BEK nr. 1358 af 18/12/2012).

; Top