Quality management of pharmaceuticals

Quality Assurance of Pharmaceuticals

Due to GMP and other specific national requirements, quality management systems (QMS) in the pharmaceutical industry are significantly more comprehensive than those in other sectors. This requires in-depth expertise, meticulous planning, and execution.

SCC is the right choice when you need assistance with establishing a QMS or are looking for strategic, scientific or regulatory advice on implementing quality-related processes. We have first-hand experience in performing quality management (QM) and can offer you step-by-step guidance on the successful implementation of QMS in accordance with GMP guidelines, QMS standards (e.g. ISO 9001) and national regulations.

Pharmaceutical requirements are crucial as they ensure that products manufactured and placed on the market are safe, effective, of high quality and do not pose unnecessary risks to the consumer.  Compliance with these requirements is strictly monitored by the competent authorities.

Establishing and Implementing a QMS

QMS regulates and documents all phases of the product's life cycle – from development through aproval to patient use. Ensuring the quality of products involves adhering to stringent procedures and processess. These can be categorised into:

  1. Manufacturing requirements
  2. Quality requirements
  3. Regulatory requirements
  4. Storage and transportation requirements

The requirements are precisely defined and described in a system of controlled documents consisting of:

  • SOPs
  • Forms and
  • Templates

In line with the EU GMP guidelines, pharmaceutical companies need to implement a robust QMS aimed at maintaining high quality standards and regulatory compliance, covering the following aspects:

  • Document management and archiving
  • Personnel and training
  • Cleaning and hygiene
  • Self-inspection
  • Quality risk management
  • Guidance on qualification and validation of devices, processes, and systems
  • Change, control, deviation and out-of-specification management

Our QM experts help you introduce and apply the quality management system tailored to the needs of your company, offering you practical guidance throughout the process and helping you keep your QMS up-to-date with the latest requirements.

Our QM Services at a Glance:

  • Developing a GMP-compliant QMS in line with the requirements in your target market
  • Preparing and maintaining a customised quality management manual (QMM) / site master file
  • Data gap analysis
  • QMS inspections and updates
  • Pharmacovigilance support
  • Professional advice on how to develop your quality policy, quality planning,  and quality objectives, including identification of quality indicators and hands-on support in process optimisation, monitoring and documentation