There are two phases to this topic. The first is auditing itself. Good
audits are well structured. They must consider the reasons for the
audit, the regulatory requirements, as well as the nature of the
laboratory being audited. We will discuss the considerations that must
be made when auditing a laboratory. The social interactions that must be
expected, the nature of the regulatory requirements and the nature of
work that the laboratory performs will be discussed.
The second
phase considers what must be considered during the audit itself. Audits
conducted by inexperienced or ignorant auditors are often worthless,
wasting the time and money of both the auditors and the laboratory being
audited. Auditors who are familiar with laboratory operations are
needed as it is easy to be fooled into thinking that a non-compliant
laboratory is operating normally. Different types of laboratories will
require different auditor/specialists. We will discuss the pitfalls that
auditors can fall into, and what questions laboratories may expect to
encounter.
Why you should attend
It is necessary for a
company to know if an analytical laboratory is capable of operating in
compliance with GMP or other regulations. This is especially critical if
the laboratory is a quality control laboratory whose test results will
be used to support the release of a product to the public or to support
and application for permission to market a product. The failure of a
quality control laboratory to comply with regulations can result in the
failure of a request for permission to market a product or a forced
recall of a marketed product.
In extreme cases a revocation of
the permission to market a product may be the result. In any case the
inability to conform to regulations will result in a loss of confidence
in the ability of the manufacturer to produce a product that meets
quality and regulatory requirements, and, in turn, lead to a refusal to
purchase a product.
It is critical that the audit of the
laboratory be conducted in a professional manner, as a poor audit will
waste money and lead to a false confidence in the abilities of the
audited laboratory whether it is internal or external to the company.
Who Will Benefit
- Potential Auditors
- Supervisors who must initiate Audits
- Laboratory Supervisors and Workers
- Quality Assurance and Control Supervisors and Lead Workers
- Supervisory Management who must select Contractors
- Managers
- Directors
- Vice Presidents who Supervise Quality Assurance
- Quality Control
- Regulatory Affairs Groups
Steven S. Kuwahara, Ph.D. is the
founder and Principal of GXP BioTechnology LLC, a consulting firm that
works in the areas covered by the GLP and GMP of drugs, biologics, and
nutraceuticals. Steve has over 30 years of experience in supervising
quality control laboratories, including an animal testing facility, and
in performing GLP and GMP audits of internal and external testing
laboratories . Steve has participated in the development of drugs and
biologicals through all phases of clinical research and final product
production.
- Choosing who should be audited
- Deciding on the regulatory requirements
- Selecting the audit team
- Contacting the laboratory and asking for the audit
- Initial interactions
- Setting up the audit file
- Setting dates for the audit
- Travel arrangements and lodging
- The opening meeting
- The actual audit. Be sure to walk through the lab
- Talk to the technicians
- Assess the instruments
- Follow the path of a sample and the test results
- Data Integrity is an issue to consider
- Assessing data integrity issues
- Test reports and certificates of analysis
- The team meeting
- The closing meeting. All issues and potential observations must be discussed
- The thank you letter. Be sure to give a date for the audit report
- Responses to the audit report
- Closing the audit