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.
- 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
DAY 1 : (9 AM – 5 PM)
Applicable regulatory regulations and Guidance documents for APIs
– ICH Q7..Good Manufacturing Practice Guide for APIs
– 21 CFR 820…Quality System Regulations (QSR)
– ICH Q10..Pharmaceutical Quality Systems
Topics commonly associated with each:
– Quality management
– Buildings and Facilities
– Process equipment
– Documentation and records
– Change control and validation
– Complaints and recalls
– Packaging and labeling
DAY 2 : (9 AM – 5 PM)
Auditing approach for API manufacturers and areas of focus
Typical audit checklist and preparation before audit. Review typical issues
Expectations for actions taken after audit..follow-up and continuous improvement steps
Supplier qualification and areas covered in quality agreements:
– Notification of changes/evaluation
– Handling of deviations
President, VTS Consultants
Mr. Christie was the Validation Manager at Parke-Davis’ Sterile Products Facility where he was involved in the review and approval of all facilities, equipment, and system commissioning/qualification activities. He had routine interaction with the FDA and European inspectors (EMEA), corporate management and third party contract-manufacturing representatives to defend validation practices and to assure regulatory compliance for the manufacture of aseptically produced products.
Mr. Christie is a speaker and trainer for several professional organizations in the US, Canada, Europe, and Asia and is a published author of several articles dealing with the challenges of aseptic processing. Additionally, Mr. Christie served as a member of the ISPE’s Professional Certification (PCC) Commission as an Examination Development Committee (EDC) member.
He possesses a BS degree in Biology from Shippensburg State University (PA) and an Executive MBA degree from Michigan State.
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DoubleTree by Hilton Hotel Philadelphia Airport
Philadelphia, PA, USA | March 21 – 22, 2019