1. Site visit to understand the current situation
1) Understand the client's policies, plans, goals and requirements for the TGA application process.
2) Understand the availability of registration/registration information required for the application documents.
3) Understand the "software and
hardware" compliance of GMP.
4) Make an objective assessment based on the site visit and give the assessment conclusion.
5) To make general arrangements and discuss the policies and strategies for the application project, taking into account the actual situation of the company.
2. Provide Australian Sponsor support services
1) For applicants who do not yet have an Australian Sponsor, the Australian branch of Conrad can act as the Australian Sponsor to provide all the Australian Sponsor support services required for the TGA application, including.
a) Providing Sponsor legal status (corporate entity).
b) Assume all legal and regulatory responsibilities of Sponsor.
c) Establishing and providing a liaison channel and mechanism between the Sponsor and the TGA.
d) Assume the responsibility of submission, acceptance, application, transmission, communication, payment and supervision between TGA and the applicant company in the capacity of Sponsor.
2) For the applicant company that already has an Australian Sponsor.
a) Provide training to the Sponsor on the responsibilities and obligations of laws and regulations.
b) Provide liaison and coordination services between the applicant company and its Australian Sponsor.
3. Application document production
1) Propose the work task list of the project.
2) Produce an outline for the preparation of documents for providing Chinese registration.
3) Provide training and guidance to the staff preparing the basic information for the client, including.
a) General control of pharmaceutical products in Australia;
b) Basic introduction to the registration of pharmaceutical products in Australia;
c) The content and requirements for the preparation of
4) Review and confirm the basic information provided by the client.
5) Preparation of registration documents and related application documents in English.
6) Assist in the submission of registration documents to TGA with the cooperation of the client's Australian registration applicant (SPONSOR).
7) Technical liaison with TGA during the registration and GMP inspection process and answer questions from TGA.
8) To be responsible for the supplement and amendment
of registration documents and other application documents during the
9) Respond to queries from the Australian Consul of the applicant company regarding the registration documents.
4. GMP Clearance and TGA site compliance inspection
Standards and Objectives: Based on the application documents submitted, Australian GMP regulations and other GMP related requirements and guidelines of the EU, we guide and lead our clients to improve the "soft" and "hard" parts of the production site, and help our clients to be fully prepared for the "site compliance inspection" of TGA. We help our clients to prepare for the "on-site compliance inspection" of TGA and finally pass the on-site inspection.
1) Assist to start the GMP Clearance and on-site inspection in cooperation with the Australian Sponsor of the applicant company
2) We help our clients to prepare for the GMP compliance inspection at the TGA production site in accordance with the Australian TGA GMP regulations and guidelines
a) GMP training
--Australian GMP interpretation and practical application
--Comparison of Australian GMP with EU GMP and Chinese GMP
--Use of Australian GMP in TGA compliance inspections and TGA concerns
--Validation and focused validation implementation
--Other topics as required
b) 2-4 rounds of "software" and "hardware" audits and corrections
--Confirmation, modification and
improvement of the environment, plant facilities and equipment (including
confirmation of GMP compliance of the plant layout)
--GMP documentation system compliance evaluation, guidance and templates for the preparation of important management procedures and operating procedures
--Guidance in the development of validation master plan, key validation program development (production process validation, analytical method validation, computer system validation, key equipment validation, important cleaning validation and sterilization protocol validation)
--Guide the implementation of various validations, review and standardization of validation reports
3) Provide experts, consultants and technicians to conduct joint "mock pre-inspection" of the company
4) Production of factory master files (SMF) required for on-site inspections
5) On-site technical and technical
translation support during on-site GMP compliance inspections of production
facilities by Australian TGA officials
6) Provide guidance and assistance to the client in the correction and prevention of inspection deficiencies (CAPA) and return to TGA
5. Certificate application and post-certificate services
1) Responsible for or assist the applicant enterprise to apply for various certificates after the application is approved
2) Provide follow-up responsibilities and work recommendations for the applicant enterprise after the application is approved
3) Provide advice on the establishment of Pharmacovigilance (PV) system after approval
As a subsidiary of Tigermed, we have a strong background and work with Tigermed Group and other sister companies to provide a one-stop service platform for domestic and international clients from R&D, registration, and transformation to production.
Over the last two decades, Canny has formed a mature and standardized service system in terms of consultant team, service standards, service protocols, project management and confidentiality system, and has passed ISO 9001 quality management system certification)for many years, providing professional services to more than 1370 Chinese and foreign clients in total.
practices in pharmaceutical industry
Global clients and partners
Global GMP inspection & certification projects
We always have a good communication with authorities, closely follow-up the updated industry trends, and establish a fully-fledged information and documents database, which enable us to have strong information integrating and analyzing capabilities so as to share with our clients and support them from R&D system establishment, clinical trials operation, RA, GMP compliance and MAH related support.