How to be successful at inspection Jenny Hantzinikolas Director, Inspections Section , Manufacturing Quality Branch Medical Devices and Product Quality Division, TGA Panel Members: Katherine Clark, Alyce Maksoud, Greg Orders, Neale Baldwin GMP Forum- 21 November 2019
Overview • The eBs application • Readiness for inspection • Meeting with TGA • Inspection process
eBs application • Have you submitted your application? – Submit your application for a new manufacturing licence or variation and the necessary supporting documents as soon as possible. – Struggling with drop down boxes, contact us at Manufacturing Quality Branch (MQB). – Provide a cover letter as part of your application indicating when you believe you will be ready for an inspection. If you are not going to be ready by this date, notify the MQB by email as soon as possible. The GMP mailbox is gmp@health.gov.au.
Readiness for inspection • To be ready for an inspection you must have: – completed constructing or fabricating the premises – taken functional control of the site (we may ask to see a certificate of occupancy or equivalent)- new site – Adequate change plan for a variation to licence
Readiness for inspection • Documented and implemented a quality system, in accordance with the requirements of the manufacturing principles and specifically tailored to your proposed manufacturing operations, that includes procedures, records and instructions for the management of: – quality systems such as deviation, change control, risk management, product quality review systems and management reviews – documentation
Readiness for inspection Production operations, including • Personnel matters including training, • master batch records clothing and hygiene Complaints • Validation and qualification • Self-inspection • Equipment assembly and calibration • Laboratory controls and operations • Maintenance, cleaning and sanitisation • Release for supply • Environmental monitoring • Pest control •
Readiness for inspection Recalls / Hazard Alert • Returns / multiple returns of human tissues • Donor consent • Donor assessment • Collection / Retrieval • Subcontracts e.g. infectious disease testing • Materials •
Readiness for inspection Qualified all relevant facilities, utilities and • equipment to at least the Operational Qualification (OQ) stage Documented and approved protocols for qualification and validation • post-Operational Qualification for all facilities, utilities, equipment and processes (including cleaning) Verification for technical transfer processes •
Readiness for inspection • Validated and or verified the manufacturing processes for biologicals (given the inherent variation in biological processes) • employed, nominated and trained all key staff responsible for controlling manufacturing operations and quality assurance • Training, continuing training, assessment and effectiveness of training
Meeting with TGA • If you would like to meet with us before you submit your application, contact the Manufacturing Quality Branch and request a meeting. – gmp@health.gov.au • TGA Inspectors are available to meet with new clients to discuss proposed plans and provide advice on the licensing and inspection process. • We can meet with existing licensed manufacturer for proposed variation to licence and facility changes
Inspection process Preparation (before inspection) o Check that you are ready for inspection. o For an initial inspection you may need a consultant if GMP is new to you o Have completed the commitments to the previous inspection (reinspection) Management (during inspection) o Behaviour at Inspection. For example, appropriate resources available, open and transparent. o Provide information requested during inspection in a timely manner o Respond to the questions. It’s OK to say you don’t know or you don’t have that information
Inspection process Follow up (post inspection) o Response is provided on time to the Lead Inspector. Don’t miss timeframes . Discuss with the Lead o Responses provided to deficiencies should address the issue and requirements on the close out record. Ensure timeframes are appropriate o If things change significantly from your commitment please let the Lead know.
Useful references https://www.tga.gov.au/industry https://www.tga.gov.au/manufacturing-therapeutic-goods https://www.tga.gov.au/publication/australian-manufacturing-licences- and-overseas-gmp-certification https://www.tga.gov.au/manufacturing-inspections https://www.tga.gov.au/manufacturing-medicines https://www.tga.gov.au/manufacturing-biologicals
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