Quality Management Systems for Small Biopharmaceutical Organizations - What small biotechs need to know about quality management systems. - BioPharm International


Quality Management Systems for Small Biopharmaceutical Organizations
What small biotechs need to know about quality management systems.

BioPharm International
Volume 23, Issue 9


A review of various regulatory requirements can cause confusion regarding actual QMS requirements. These requirements are best defined in the FDA's quality system inspection technique (QSIT):

  • quality system
  • facilities and equipment systems
  • materials systems
  • production systems
  • packaging and labelling systems
  • laboratory systems.

The elements required of these systems are described further in detail. The organization then can assess what elements are necessary for their business operations at their current stage of development. If an element is not necessary, a statement is made in the documentation of the QMS. This ensures that all necessary areas are considered as the organization develops and the QMS stays aligned to the business. The organization also must consider elements not described in the QSIT documentation such as EU-driven requirements for clear quality (technical) agreement between the company and its suppliers.

Selecting appropriate elements from a well-designed and compliant electronic system (e-system) is the most effective way to allow the QMS to develop as the business grows and its needs change. Ideally, an e-system would be populated with generic documents that could be individually tailored as required to meet the needs of the organization. Regular updates to the generic documents should be made annually to ensure continued compliance with changes in regulation and incorporation of best practices to the QMS.


At this point it makes sense to consider what a simple system really means. The documents in the QMS must effectively describe the key processes being used by the organization, but in a nonbureaucratic manner. The application of common sense goes a long way to ensure that documents and associated systems are well designed and effective in their application. The organization should develop a hierarchy of documents starting with policies at the top, which lead to the necessary procedures in the QMS.

There must be a solid and concerted disciplined approach to prevent the number of documents from increasing as the business develops. Adding documents will be necessary, but each one must be carefully considered to prevent the QMS from becoming unwieldy and disorganized.

Of course, a proactive training strategy is a key element of the application of a simple, well-designed QMS, and the development of the QMS must be done hand in hand with a well thought out training strategy. The organization also must consider whether there is a need for a cultural change as the QMS is deployed. The key to a successful QMS is the people who operate it—therefore, the culture, training, and organizational structure must embody the best approach to gaining staff engagement and alignment to the business strategy.


In both the biopharmaceutical and pharmaceutical sectors, a simple well-designed quality management system (QMS) can be a real business asset to an organization. It can ensure that the organization stays productive as it grows and develops. Effective application of a QMS will not only ensure compliance with regulations and ensure that the needs of the customers are met, but also will reduce risks and allow the organization to achieve and maintain a competitive level of productivity.

This can most effectively be done through a compliant e-system that contains well-written documents that clearly describe the processes used in the organization. A strong training strategy must accompany the introduction of the QMS, and the organization also must consider if there are any cultural or organizational elements that must be built into the implementation strategy for the QMS. This can be facilitated by a well-designed QMS that ensures correct alignment and engagement of the whole organization.

Graham Clapperton is the associate director of quality and compliance and Michael Gamlen is the managing director, both at Pharmaceutical Development Services, Ltd., Nottingham, UK, +44.115.9124277,

blog comments powered by Disqus



Bristol-Myers Squibb and Five Prime Therapeutics Collaborate on Development of Immunomodulator
November 26, 2014
Merck Enters into Licensing Agreement with NewLink for Investigational Ebola Vaccine
November 25, 2014
FDA Extends Review of Novartis' Investigational Compound for Multiple Myeloma
November 25, 2014
AstraZeneca Expands Biologics Manufacturing in Maryland
November 25, 2014
GSK Leads Big Pharma in Making Its Medicines Accessible
November 24, 2014
Author Guidelines
Source: BioPharm International,
Click here