With an ever increasing practice of contracting out services and the demand of APIs for numerous drug products, the assurance of quality practices for their manufacture is an area of concern for all parties involved, including regulatory inspectors. In addition, it is an often incorrect assumption made by companies who continue to think that if services are contracted out, that their responsibility for maintaining quality and regulatory compliance goes with it. As with any service, or product contracted out t’s in the suppliers’ interests to keep themselves to a high standard of quality to attract clients, but the regulatory burden ultimately rests on the company receiving their products or service. Therefore, the monitoring and managing of quality issues, practices and processes is extremely important when outsourcing anything that could potentially impact the product received or service performed.
This seminar will examine the expected practices and expectations as defined in the “Guidance for Industry, Q7A” known as “Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients”. In addition, there are requirements for the control of suppliers as found in 21 CFR 820 used as the basis for all audits, and in “Q10 Pharmaceutical Quality System Guidance”. This guidance extends quality systems responsibilities for drug makers to the activities they outsource. One particularly important clause states that contract givers “should be responsible for assessing the suitability and competence of the contract acceptor to carry out the work required.” It also establishes that all responsibilities for quality-related activities between the two parties should be specified in a written agreement. This is usually covered in quality agreements which will also be discussed.
Why You Should Attend:
Attendees will define the critical steps to review during an audit to assure that the following, as defined in the Guidance document are adhered to: “Each manufacturer should establish, document, and implement an effective system for managing quality that involves the active participation of management and appropriate manufacturing personnel”.
The system for managing quality should encompass the organizational structure, procedures, processes and resources, as well as activities to ensure confidence that the API will meet its intended specifications for quality and purity. All quality-related activities should be defined and documented”. The seminar will also provide suggested steps in conducting the audit, including preparation, approach and how to address observations made. As one person stated, “it often takes more time to address observations than it did to get through the audit. Whether the attendees are the auditors or the ones audited, this section will provide valuable insights into recommended activities. There will be plenty of opportunity for attendees to share experiences, questions and discuss actual case studies of the presenter. An audit checklist will be provided to help attendees improve their approach prior to conducting the audit.
Areas Covered:
Review the current regulatory requirements for control of suppliers, regardless of what they provide
Discuss steps for preparation, execution and summary of audit findings
Review an audit checklist and openly discuss with regards to current practices of attendee companies
What are the typical topics covered in a quality agreement
What are some common deficiencies cited by regulatory auditors when auditing supplier qualification processes
Who Should Attend:
Quality Assurance Management and Staff
Quality Control Management and Staff
Manufacturing Management and Staff
Production Management and Staff
Regulatory Affairs Management and Staff
Operations Management and Staff
Laboratory Personnel