Valuing Starting Materials

We rate substances
to help manufacturers
demonstrating quality

We reassure pharma
buyers for a
better selection

CODEMA PHARMA

CODEMA PHARMA defines a voluntary assessment process of pharmaceutical substances and starting materials.
We select and evaluate data from local producers, and establish a rating, according to specific protocols.

We aim at:
Improving the quality of pharmaceutical substances and the Supply Chain Integrity
CODEMA PHARMA, A sign of quality for pharmaceutical substances and starting materials

RATING PROCESS

Supply chain in the pharma industry is a complex and long process that is resource and time-consuming.
Majority of APIs producers in the world are based in China, that is where CODEMA chose to heavily invest in order to help bridge the trust gap between APIs Producers and Buyers from Europe and North America.

CODEMA created a Voluntary Disclosure rating system to evaluate the APIs producers, in order to facilitate Buyers' decision in choosing the right supplier.
The collection of information and on-site visit is executed by third-party CODEMA Acknowledged Expert (CAE), thus allowing an impartial process.
CODEMA will then process the information collected and provide a rating based on the following data:

General Criteria
1. Availability of information
2. Range/scope of information

Specific Criteria
3. Substance Characteristics
4. Audit, DMF, Laboratory Test.



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QUARTERLY SUBSTANCES REPORTS

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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.

CAE 003

Education: holds a bachelor degree in pharmaceutical engineering.
Professional experience: 12 years of experience in pharmaceutical industry.
He was quality director at a pharmaceutical company, mainly in charge of the following: establishing quality system as per ICH guidelines, and implementing and improving the system; daily management of QA and QC; handling inspections and audits; and auditing suppliers, etc.
He has first-hand experience in US FDA, WHO, Japan PMDA inspections for API/intermediates, as well as in DMF preparation and method validation/process validation/cleaning validation.
Languages: fluent in Chinese and good in English.
Geographical coverage: based in Hubei - willing to travel anywhere in China.

CAE 004

Professional with a robust expertise in GMP compliance, acting since 15+ years in Regulatory R&D and Quality disciplines for APIs and FDF products industry with increasing compliance responsibility, higher management roles and wider strategic vision and efficacy. Performance-driven professional with outstanding Pharmaceutical RA/QA knowledge, strong problem solving capabilities and strategic thinking attitude, featuring high level of professionalcommitment andvalues.

CAE - provisional C

Education: master degree in medical chemistry.
Current role: senior engineer and visiting professor of Advanced Research Institute of China FDA; GMP auditor and consultant. He retired from a city level FDA in 2014 and later has been working as consultant and auditor.
Professional experience: extensive experience in working in pharmaceutical manufacturing companies and participated regularly in US FDA inspections.
While working at the FDA, Expert 1 performed GMP inspections inside and outside China and conducted trainings for CFDA GMP inspector and was invited to observe inspections performed by US FDA, TGA, EU authorities and WHO to Chinese manufacturers. From 2012 to 2013, Expert 1 was GMP inspector of Centre for Food and Drug Inspection of China's FDA.
From 2011 to 2015, Expert 1 provided GMP trainings and consulting services for pharmaceutical industry to help them to pass inspections by China FDA, EDQM and US FDA.
Languages: fluent in Chinese and English.
Geographical coverage: based in Jiangsu Province - willing to travel anywhere in China.

CAE - provisional D

Education: bachelor degree in bio-engineering and master degree in GMP project management.
Current role: GMP consultant and auditor leading a GMP auditing team.
Professional experience: more than 10 years of experience in quality management in two multinational pharmaceutical manufacturing companies. Her experience includes the following areas: supplier audit for APIs, excipients and packaging materials; QC laboratory management; SAP key user management; design and establishment of microbiological laboratory; GMP project consulting; and third-party audit for APIs, excipients and medical devices.
Languages: fluent in Chinese and English.
Geographical coverage: based in Shanghai - willing to travel anywhere in China.

CAE - provisional E

Education: licensed pharmacist and quality engineer with a bachelor degree in applied chemistry.
Current role: GMP auditor.
Professional experience: 11 years of experience in pharmaceutical/chemical industry.
Expert 3 worked as QA supervisor, QA manager, quality manager in different pharmaceutical /chemical companies and project manager in a pharmaceutical design and engineering company.
When worked as QA manager and quality manager, Expert 3 was responsible for both QA and QC, and performed audits of APIs and chemicals many times.
Languages: fluent in Chinese and English.
Geographical coverage: based in Shanghai - willing to travel anywhere in China.

CAE - provisional F

Education: licensed pharmacist.
Current role: in regulatory affairs area; technical expert at the biggest association in China's healthcare industry.
Professional experience: She is familiar with Chinese GMP, US GMP, EU GMP, WHO GMP and ICH guidelines for chemical drugs.
She started work in 2001 in a QC laboratory and later in RA area, and worked as RA director and GMP internal auditor at an API manufacturer. Expert 4 has experience in CEP, ASMF, WHO APIMF, Japan MF, Korea DMF and Brazil DMF and in GMP inspections from EDQM, WHO, ANVISA, KFDA, US FDA, and Mexico.
Expert 4 also has experience working as contact person between competent authorities/buyers and the company, working with buyers in getting market access and interpreting for inspections/audits.
Languages: fluent in Chinese and English.
Geographical coverage: based in Zhejiang Province - willing to travel anywhere in China.

CAE - provisional G

She has 15 years of experience in pharmaceutical companies, including approximately 8 years in QC laboratory. She is familiar with Chinese GMP, US cGMP, EU GMP, WHO GMP and ICH Q7 and knows how to establish quality system in accordance with the regulations, ensuring the quality system is effectively implemented and improved. As a QC manager and QA manager, she worked with Jingxin Pharm and Viwit, led the team to pass FDA, EDQM, WHO Brazil ANVISA, Korea FDA, Korea FDA and Mexico FDA GMP inspections, and customer GMP audits. Shuwen has rich experience with quality control technology and management. She is a Licensed Pharmacist with laboratory data integrity management and supervision experience, as well as team building and management skills. As an independent GMP consultant since the end of 2016, she assisted an OTC manufacturer in establishing a FDA compliant quality system and trained their team members. The manufacturer passed US FDA GMP inspection in last June successfully.

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