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
- 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
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