Quality Management
What is Quality Managment?
We at Biocodex PhaMe offer a wide range of services to support your quality management system. Our experts are familiar with ISO 9001 and 13485 standards and industry-specific quality standards for wholesaling and manufacturing operations (GDP and GMP). We can help you in evaluating the effectiveness of your quality systems, updating them or even creating new ones.
Our experienced auditors master both pharmaceutical wholesaler and manufacturer audits. In addition, our expertise encompasses pharmacovigilance and registration audits, mock audits in preparation for official audits as well as internal audits – anywhere in the world.
Our Services:
Quality Management System
The quality of medicines is monitored throughout their entire life cycle via a Pharmaceutical Quality Management System. EU legislation requires that each marketing authorization holder, manufacturer and wholesaler/distributor has a Quality Management System in place.
We provide the necessary services for maintaining a functional system, including:
- Development and maintenance of a Quality Management System
- Creation and updates of the needed instructions, Standard Operational Procedures (SOPs) and Quality Manuals
- Training
- Support for Internal and External audits
Audits
Audits are needed to maintain the Quality Management System as instructed. Audits are necessary when outsourced activities are evaluated and to support the selection of critical suppliers and vendors.
We provide professional support for global pharmaceutical audits. Our experienced auditors master both pharmaceutical wholesaler (GDP) and manufacturer (GMP) audits. In addition, our expertise encompasses pharmacovigilance and registration audits, mock audits in preparation for authority or partner audits as well as internal audits – anywhere in the world. In addition, we offer well-organized and cost-effective remote auditing. In addition, Biocodex Phame qualified auditors can act as your support during inspections by competent authority or perform gap audits before inspections by competent authority or audits carried out by a partner.
Our auditing service includes audit preparation, conduction of the audit, reporting and based on your needs also anticipation in preventative and corrective action planning, approval or follow-up.
- GMP audits all over the world
- APIs
- Excipients
- Contract manufacturing
- Sterile manufacturing
- Packaging materials
- GDP audits
- Wholesaling
- Warehousing
- Transportation
- Other audits
- Food supplements
- Medical devices
- Cosmetics
- Internal audits
- Mock audits
GDP Responsible Person / Responsible Pharmacist
Responsible pharmacist is required for holders of wholesale distribution authorization for ensuring the implementation, maintenance and improvement of quality system. From Biocodex Phame we can act as your local GDP responsible person for quality contact in the Nordic and Baltic markets.
Applications for GDP or GMP licences
As readiness for the wholesaler or manufacturer license is demanding, we offer a wide range of activities to support your quality management system. We can assist in GDP and GMP license application processes by reviewing and if needed, compiling necessary SOPs, create documentation to support your application and act as contact person for authorities.
Product Quality Complaints
Efficient and timely PQC’s handling is required to follow the safety of the products, prevent possible patient injuries and take necessary actions. Even if the product defect is not involved in the case, the product quality complaints serve as important tool for continuous improvement and planning required actions.
By outsourcing the PQC’s to Biocodex Phame, our experts will handle the case recording, reporting, follow-up and response to the complainant, and if required, reporting to the authorities for you.
Compliance Follow-up
Being kept up-to-date on legal changes and upcoming issues is essential for pharma and health technology companies. At Biocodex Phame we can help to follow regulatory updates and inform about the latest news in the field. From following the legal changes based on the topic and countries of relevance, to provide a summary about the updates and other relevant information in the field. We can adjust the frequency of the updates and changes communication to your needs.