PHDS HEALTHCARE RESEARCH Co., Ltd.
Visit and exchange with foreign pharmaceutical companies and GMP training
Release time:
2015-09-21
At the invitation of a foreign injectable drug manufacturer, the expert team from Beijing Boshi Zhixing Pharmaceutical Technology Co., Ltd. (PHDS) conducted a visit, exchange, and GMP training at the production facility from September 21 to 24, 2015, guided by GMP and pharmacopoeia standards.
The GMP training for foreign pharmaceutical companies has been completed.
At the invitation of a foreign injectable pharmaceutical company, the expert team from Beijing Boshizhi Star Pharmaceutical Technology Co., Ltd. (PHDS) conducted a visit, exchange, and GMP training at the production facility from September 21 to 24, 2015, guided by GMP and pharmacopoeia standards.
On-site visit content:
Warehouse (raw material warehouse, formulation warehouse, packaging material warehouse), active pharmaceutical ingredient workshop (dynamic), injectable workshop (dynamic, static), purified water system, water for injection system, air conditioning system, QC laboratory, document management library, etc.
Exchange training content:
1. On-site visit and exchange of pharmaceutical production, regulatory training;
2. Explanation of risk classification and analysis of defects;
3. Feasibility assessment training for multi-variety co-line production;
4. Case explanation: rectification and improvement of "defect examples from on-site inspection of imported drugs";
5. Verification of key control documents at the production site: consistency issues between batch production records, key parameters, and application materials.
After 4 days of intensive visits, exchanges, training, and case explanations, there were many gains, and the feedback from the pharmaceutical factory was very positive. The expert group identified and proposed more than 40 targeted opinions and suggestions, aimed at helping the pharmaceutical factory successfully pass GMP certification and the registration verification of imported drugs, which is of great significance.
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