Nov 28, 2017

About the author

Dr. Gina Stetsko

Dr. Gina Stetsko is a senior pharmaceutical development and manufacturing executive with over 35 years experience, including 23 years in the start-up pharmaceutical field. She holds a PhD in Pharmaceutics from Purdue University.

Topic tags

Novateur, Regulatory

Quality Assurance: An Important Contributor to Value Creation

For most start-up pharma companies the drive to the next fundraising milestone and value inflection point consumes most of their planning. Sometimes, however, some of the details “behind the scenes” can be deprioritized, such as a designated person responsible for quality assurance, a preliminary quality system and quality procedures.

From a regulatory perspective a quality assurance function ensures compliance with regulatory guidances and the integrity of the data generated by all parties involved so it is suitable for regulatory submission or for review by potential future partners.

Quality Assurance clearly needs to ensure compliance with GLP, GMP and GCP requirements (collectively GXP). Studies conducted under these guidelines are inextricably linked, so all need to be addressed in a similar manner.

However, compliance goes beyond just meeting regulatory requirements since it can also serve to prevent wasted time and money on delays or repeating GXP activities and also supports informed business decision-making.

Some issues recently seen with clients include:

  • R&D staff found a second supplier for a key active ingredient for use in a drug device but the supplier was not audited and qualified. The material received was later found to be sub-potent which delayed the start of a clinical trial.
  • R&D staff faced a tight timeline to produce clinical material for a Phase 2 trial and agreed to batch record changes without QA review that jeopardized a link to a completed Phase 1 study.
  • A company chose a well-known API supplier and did not conduct an audit or complete supplier qualifications. Since the API supplier has supplied many companies worldwide and has many regulatory approvals, qualification was not considered important. An audit conducted many months later found that this particular API was manufactured in a smaller facility with many potential sources of contamination. This placed preclinical studies and a clinical trial in jeopardy since the material was deemed non-compliant.
  • A company with no staff responsible for QA used a contract manufacturing firm that had many deviations that required review and laboratory retesting procedures that were not compliant. Company staff provided no initial oversight for batch release and problems were discovered later.


Some management teams feel that using a contractor’s quality system or SOPs is a way to avoid the time, cost and effort to develop an internal quality system. However, the ultimate regulatory responsibilities will always lie with the sponsor company. Contractor systems and procedures can be useful but they only play a role in the overall quality system of the sponsor company.

A simple way to address this without spending a great amount of time and money is to contract with an experienced quality assurance services firm or find a qualified quality assurance consultant who can fulfill the role of an internal responsible person. If funds allow, a person experienced dealing with a virtual development environment could be hired.

It is essential that a start-up company address their quality system very early on. Some of the details that need to be addressed include:

  • An Independent Quality Unit or Responsible Person
  • A Documentation System for GXP protocols and reports
  • A Supplier Qualification and Auditing Program for all GXP contract sites
    Batch Disposition procedures to release GLP test articles and GMP clinical supplies
  • A system to handle Deviations, Investigations and Corrective/Preventive Action (CAPA) Controls at contract sites
  • Personnel Training Program (as required)

While the pursuit of quality can be a costly line item, successfully establishing accurate product requirements and risk mitigation strategies early on will result in significant savings over the product development lifecycle.

Establishing an internal quality system can be a very simple process to start with and the system can gradually grow as the programs progress and additional funds are raised.

The main issues to address are the acceptance of the need for this function and locating the assistance required. This investment is guaranteed to pay dividends for start-up companies and is essential to support value creation.

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