Based on years of hands-on practices in international GMP inspection and certification services and with the guidance and cooperation of our professional partners in EU, we are able to support Chinese companies who is looking for accepting European GMP inspections so as to obtain EU GMP certificate, our services include:
1. On-site visit to understand the updated situations in the Site
a) Well understanding the motivations, objectives, policies, plans and requirements of the company for EU GMP certification;
b) Getting a full picture for "software and hardware" with the Site and their gaps against with EU GMP;
c) Assessing the project feasibilities and gaps based on the site visit and communications;
d) Formulating the draft project strategies and roadmap for launching.
2. EU GMP application and preparations
a) Guiding customers to select a suitable submission product;
b) Assist in EU partner and Applicant assessment and coordination;
c) Guiding for a proper submission procedure and the Competent Authorities, alternative countries e.g. Netherlands, Germany, France, Spain;
d) Aligning customer with local EU resources to submit the application and trigger the inspection;
e) Acting as a liaison between the Authority and customer;
f) Coordinating and arranging for the inspection preparations and acceptance.
g) Guiding customer to pay right to the Authority;
h) Onsite support before-during-after onsite official inspection;
i) Post-inspection follow-up.
3. On-site inspection
Based on the submission dossier, EU GMP regulations and guidelines, we will guide our customer to improve "software" and "hardware" related to the applied Product, and support them to prepare for the official inspection acceptance to make sure they will get ready and pass the on-site inspection.
a) Guiding our customer to allocate resource to prepare and arrange for the inspection acceptance.
b) Participating in the whole preparation procedure to make sure our customer gets ready for the inspection:
i. EU GMP training
- EU GMP interpretation and practices
- Comparisons between EU & China GMP
- EU GMP applications during the inspection and Focuses
- Validation and key validation implementation
- Other topics
ii. Rounds of Audits and CAPAs guidance:
- Onsite review for the facilities, utilities and equipment, follow and guide for renovation if any;
- Overall review for the QMS documents, attentions will be paid more to critical SOPs, templates will be provide at request;
- Review for SMP, assist in validation protocols drafting for key items which mainly include production process validation, analytical method validation, CSV, key equipment validation, cleaning validation and MF.
- Remotely/onsite guidance for testing execution and review for the validation reports.
c) Mock-inspection before the official inspection with our Experts to challenge for both procedure and SME.
d) Guiding customer to prepare for SMF.
e) Onsite Experts and interpreter support during EU GMP inspection.
f) Continuous support for CAPAs and response after the inspection.
4. Duration and Certificate validity
Business communications & contract: 1-2 months
Candidate EU Applicant selection & contract: 1-2 months
Project KOF & application submission: 1-3 months
Site preparations; 3-6 months
Official inspection notification: 3-6 months
Inspection carrying out: 1-3 months
Approval and certificate issuance: 1-3 months
The above activities will be proceeded in simultaneously as much as possible to shorten the whole project timeline, in total it will be need 8-12 months.
b) Certificate validity
Three years in most of EU countries.