CRO
Introduction:

Pracgen is dedicated to providing pharmaceutical R&D and manufacturing enterprises with high-quality systematic services across all phases of the drug’s life cycle (including product development, technology transfers, commercial production, and product termination) in accordance with the GLP/GMP rules of China, the EU, the USA, the WHO, and other institutions. This includes certification consultation, education and training, compliance auditing, confirmation & verification, and inspection & testing.

Pracgen team have extensive backgrounds in the pharmaceutical industry and years of professional experience in GLP/GMP in pharmaceutical R&D/production/CRO/CDMO industry, and have served many clients to meet their expectation.

Procedure:

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Advantages:
  • Flexible

    Personalized & flexible collaboration methods 

  • Major

    Rich pharmaceutical R&D/ production/ CRO/ CDMO experience

  • Promise

    Focus on pharmaceutical R&D and the pharmaceutical production industry

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Risks control

Risk of issuance of drug production license:

1. Authenticity problems found on-site inspection;

2. Plant layout is inconsistent with the declaration;

3. Facilities and equipments are inconsistent with the declared materials;

4. Plant construction problems;

5. The manufacture conditions do not meet GMP requirements;

6. The management documents of manufacture and quality are not complete.

 

Drug registration and development site check risks:

1. Authenticity problems found on-site inspection;

2. The researchers and facilities are inconsistent with the declaration materials;

3. The production site does not meet the necessary requirements;

4. The process and procedures are inconsistent with declaration data;

5. Fabricating original research records and experimental data;

6. The manufacture conditions of clinical test samples and the declared samples do not meet GMP requirements;

7. There is no legal source or inspection report for raw materials and auxiliary materials of trial-produced samples or packaging materials directly in contact with drugs;

8. The batch record of trial sample is inconsistent with the declaration data;

9. The trial production quantity, usage and residual quantity of trial production samples are unbalanced;

10. The time and content of the log record of the instrument and equipment are inconsistent with the declared data;

11. There is no legal source of standard/reference, no standardization record of working reference;

12. Record filling violates good record specification.

 

Drug registration and production site inspection risk:

1. Authenticity problems found on-site verification;

2. The actual data is inconsistent with the declared data;

3. The manufacture process is inconsistent with the declared process;

4. Manufacture operation is inconsistent with SOP;

5. The instruments, equipment and materials are inconsistent with the declaration;

6. Batch record is inconsistent with declaration;

7. Production personnel was not trained;

8. Instrument and equipment are not checked, or no use log;

9. Material storage quantity, usage quantity and stock quantity are unbalanced;

10. Manufactured conditions do not meet GMP requirements

11. The samples of production are unqualified

12. Record filling violates good record specification


Materials preparation

Subject to related requirements of provincial government service platform


Relevant laws and regulations

 Laws :

Drug Administration Law;

Regulations :

Regulations on the Implementation of the Drug Administration Law;

Administrative Rules :

Good Manufacturing Practice

Good Manufacturing Practice Appendix: Sterile Products

Good Manufacturing Practice Appendix: Biological Products

Good Laboratory Practice

Quality Management Specification for Chimeric Antigen Receptor Modified T Cell (CAR-T cell) Formulation

Quality Management Specification of CAR-T Cell Technology Products

Guiding Principles :

Technical Guidelines for Research and Evaluation of Cell Therapy Products

Self-discipline Specifications for Quality Management of Immune Cell Preparation

Key Consideration for Quality Control Testing Studies and Non-Clinical Study Studies of CAR-T Cell Therapy Products


Flow chart of Drug Manufacturing Certificate issuance

See provincial government service platform

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