Seamless Compliance for Pharmaceutical Laboratories
Pharmaceutical manufacturers are governed by a plethora of stringent national and international standards and regulations, such as Good Manufacturing Practice (GMP). Compliance with guidelines, legal requirements and life cycle management is increasingly important to the success of a business, requiring an in-depth understanding of the regulations and an efficient approach to manufacturing.
The World Health Organization reports that there are pharmaceutical production facilities in 124 countries across the globe. Irrespective of their location, each of these manufacturers must comply with strict national and international regulations that ensure the safety and efficacy of pharmaceutical products. This demands an in-depth understanding of the relevant regulations, as well as processes, technology and metrology, to ensure compliance.
Achieving regulatory compliance requires significant investment; regulations must be implemented and processes developed and validated. However, the guidance provided is frequently, and intentionally, quite broad, for example, simply stating that measuring devices must be calibrated. This leaves the manufacturers to define criteria suitable to ensure regulatory compliance, such as the frequency of calibration. While this gives flexibility to adapt quality control procedures to specific process requirements, it also leads to a degree of uncertainty.
This guide highlights products and solutions designed to help pharmaceutical laboratories establish effective, lean systems of regulatory compliance, including developing and implementing internal controls and procedures. It covers:
- Solutions to support the fulfilment of GMP and pharmacopeia standards
- A concept for efficient data management focusing on data integrity
- Products offering features and user management to help achieve compliance and adherence to SOPs
- Advice on the selection, installation and verification of analytical instruments and weighing systems
- Service solutions to enhance product quality and regulatory compliance
- Guidelines to establish efficient life cycle management