In the pharmaceutical industry the quality control team is constantly confronted with the need to determine a growing number of parameters with high quality and as effectively as possible. The regulations of the pharmacopoeias (US, Pharm. EU or Japan) and the internal regulations of the manufacturers change constantly. The solution: modular multiparameter measuring systems with comprehensive service throughout the working life of the instrument
The optical rotation, density, refractive index, turbidity, pH value and color of liquids all play an important role in quality control checks. The determination of these parameters is important in order to check the quality of the incoming raw materials and also the quality of the end products. The quality assurance team therefore needs to determine quality-relevant parameters on delivery, during the production process and during the final check on the product.
In pharmaceutical companies, for example, the precise analysis of numerous quality-relevant parameters is essential due to the existence of international standards, legal requirements and the responsibility towards the customer and society in general.
Defined work steps, trained personnel and reliable instruments and plants are indispensable for quality control.
How can pharmaceutical companies profit from instrument manufacturers?
Time, money and the efficient use of human resources play an important role in all producing companies. By actively involving the supplier’s know-how and the supplier’s support and service it is possible to make savings in all of these areas.
This begins with the risk assessment for a new instrument: Nobody knows more about the risks than the instrument producer itself. If the manufacturer is also familiar with the relevant guidelines, such as GMP, cGMP, 21 CFR Part 11 and GAMP5 , then it can also provide the pharmaceutical company with a comprehensive package of expertise, active support and documentation which fulfills the regulations of the industry. This includes, for example, a risk-based qualification documentation with which the instrument can be integrated into the production workflow via defined tests in order to comply with pharmaceutical specifications.
This means pharmaceutical companies do not need to spend a lot of time before the qualification process getting to know the instrument, creating a risk assessment and implementing this into the qualification documentation.
In addition, the qualification includes a custom-tailored and documented training for all people defined by the pharmaceutical company. The auditors of national authorities or the FDA (Food and Drug Administration) regularly check whether the measuring instruments meet the requirements of the guidelines, whether data is handled in a traceable way (Audit Trail) and whether the employees are sufficiently trained for their job. If an instrument manufacturer offers specific product training as part of the qualification, the pharmaceutical company also profits from this.
As part of the qualification process (PQP – Pharma Qualification Package), Anton Paar offers an additional instrument-specific instruction manual (called SOP, Standard Operating Procedure) in the language of the country. This process specification can be implemented as required into the defined laboratory workflow for operation of the instrument after approval by the quality manager.