The pharmaceutical industry is recognized worldwide by the narrow quality standards by which it is governed, whether mandatory requirements as imposed by international or national law, whether by guidelines drawn up and implemented by various Quality organizations.
Compliance with these requirements is a critical step for any company wishing to enter this market. Being applied holistically along the drug chain, it is applicable from the manufacture of medicinal products to their distribution or Medical Devices.
In order to help our clients and other companies, PHAGECON offers a portfolio of services in this area that can cover all areas and needs, from the preparation of documentation to the liaison with the authorities to obtain the most various certifications. In addition, and considering the need of its clients to be distinguished by the quality, and as such, in order to obtain other ISO certifications, PHAGECON also includes in its services support to obtain these extra certifications.
Quality Management Systems
- Design and Implementation of a Quality Management System in accordance with the various rules in force for the various segments (General, Drugs & API's, MD, cosmetics, etc.);
- Review and Improvement of the Quality Management System;
PHAGECON aims, at all times, to provide the highest quality standards service to its clients. Therefore, each QMS is considered a different entity, being designed and implemented not only in accordance with the legislation but also, the expectations and internal guidelines of each client.
Good Manufacturing Practices
- Being the predominant the Quality Area, GMP Compliance is a must for the Pharmaceutical Industry and PHAGECON can provide support in several areas, namely:
- Purchasing and Logistics;
- Quality Control;
- Computer Support and Maintenance;
- Quality Assurance / Management.
- Submission of application for GMP approval to the NCAs;
- Liaison of the process with the NCAs until certificate issuance.
Good Distribution Practices
- Audit / Gap analysis of existing GDP Procedures implemented in the companies;
- Preparation of SOPs in accordance with the European and National Legislation covering all areas for the distribution of Medicines for Human Use;
- Submission and Management of Licensing procedures to obtain approval for the Distribution of Medicines for Human Use or Medical Devices;
- Provision of a Technical Director (MUH) or Responsible Person (MD) in accordance with the GDP requirements.
Having developed its auditing services, PHAGECON offers its clients the possibility of performing:
- Internal and External Audits;
- General or Specific audits (Drugs, API's, MD, Cosmetic) always in accordance with the legislation in force.
Qualified Person Service
Essential to enter the European Pharmaceutical Market PHAGECON can provide a QP service that includes:
- A unique ‘Product Supply Route Map’ to guide you to the correct solution for your clinical or commercial requirements;
- Audits of manufacturing facilities, including drug / substance (as required), primary and secondary drug product manufacturing operations, ensuring compliance with GMP equivalent to the European requirements;
- Advice on issues including expiry updating and meeting the requirements of any conditions applied by the authorities;
- Review, certification and release of all dosage forms;
- For marketed products, we will certify the product in accordance with the relevant marketing authorization QP-Certification, release or advice for EU and 3rd countries;
- General QP oversight and support.