Setting High Evaluation Standards
for Pharma Industry
We support manufacturers and suppliers
demonstrating their committment
to high industrial standards
Our evaluation system provides pharma companies with standardised criteria of evaluation in different fields
of pharma supply chain
ABOUT
In 2009 we started developing protocols which aims to providing qualitative and compliance information about critical items for global pharma supply chain.
CODEMA PHARMA is an ideal partner for finding the meeting point among pharma suppliers and pharma buyers.
The procedures for assessing quality and compliance has been developed through a process of standardization of criteria applied in Pharma Sector for qualifying suppliers.
Cooperation with Sector bodies and institutions makes CODEMA PHARMA dynamic in addressing the needs of companies and developing new protocols or revising existing ones.
CODEMA PHARMA is a partner of pharma industry and a partner member of the European Federation of Generic and Biosimilar Medicines(Medicines for Europe) https://www.medicinesforeurope.com/medicines-for-europe/#section-5
CODEMA PHARMA EVALUATION SYSTEM
Standardising criteria of evaluation is a key element in the CODEMA PHARMA approach.
The evaluation is based on evaluation protocols with specific scopes, these cover among others, topics such as:
- • GXPs
- • Quality and compliance
- • Regulatory additional testing and requirements
- • Integrity
- • Plants and Equipments
- • EHS (environment, health and safety)
- • N-Nitrosamines Risk Assessments (to learn more, please visit: www.codemapharma.com/nitrosamines)
Evaluation Protocols are subject to constant revision taking into account the most recent indications coming from the industry. CODEMA PHARMA operates according to Rules of Procedures and guarantees neutrality and independence similar to those of a certification body.
Criteria of acknowledgment of experts and auditors are transparently defined in the CAE Application process.
A Warning Policy provides for measures to be taken in case of infringement of auditing rules by the CAEs (auditors) or by applicants.
Specific procedure provides for interested subjects (pharma companies) to suggest potential suppliers to apply for CODEMA PHARMA evaluation (Suggestion of Evaluation) as a mean for facilitating their selection or better qualifying an existing supplier on specific subjects.
CODEMA Acknowledged Expert (CAE)
CAE’s are independent pharmaceutical professionals - freelancers or working for larger companies, who are consultants of pharmaceutical substances or starting material producers in GMP and/or regulatory or other related issues.
CAE’s have their own professional responsibility and has no commercial ties with CODEMA PHARMA.
In order to be "acknowledged" by CODEMA PHARMA and become a CAE, the experts and consultants have to comply with following criteria:
• They have been recognized or accredited or indicated by or are a member of a local or international pharma body or organization.
• They have been previously appointed - personally or in a team - for carrying out audits or other similar activities or for other consultancies, in the interest of EU or US pharma buyers.
• They have published Sector technical or scientific articles in known reviews.
A special written endorsement of an expert by a known local or international body or organization may substitute one of the above criteria.
According to a transparent warning policy, CODEMA PHARMA will keep records of any communication received by users (producers or buyers) on the content of professional activity of each CAE within the framework of the rating process.
PROCEDURES AND
EVALUATION PROTOCOLS
Rating Program evaluation system is operated pursuant to specific standard procedures.
Here below you can access and download material documents (simply providing: Name, Surname and Email), as follows:
• CODEMA PHARMA Rules of Procedures
• Rating Program Application
• Evaluation Protocols
• CAE Application (for auditors)
Clos Chapelle-aux-Champs, 30
B-1200 Brussels - Belgium
tel +32 2 880 62 24
fax +32 2 880 62 01
info@codemapharma.com