MEXICAN HEALTH AUTHRITY (COFEPRIS) GUIDELINE
The Mexican halth authority guideline is not much popular in
the pharmaceutical sector compaired to the other regulatory agencies
guidelines.
The Mexican heath authority which is called as COFEPRIS. The full
form of the COFEPRIS is “Comisión Federal para la Protección contra Riesgos
Sanitarios”.
COFEPRIS is an official organisation of the Mexican
government. This agency is founded to monitor and control manufacturing and
import of the health products.
The health products include Medicinal finished
dosage forms, active pharmaceutical ingredients, organ transplants etc.
The COFEPRIS authority has their own guideline to approve
the drug product manufacturers and active drug manufacturers.
The applicable COFEPRIS guideline are-
NOM 164 SSA1 2015: - This guideline is applicable for the
active drug manufacturers like API, drug products in the form of semi-finished
goods like pellets, DC powders.
NOM 159 SSA1 2016: - This guideline is applicable to the
manufacturers of the finished products like tables, capsules, ointments,
medicated creams etc.
These both guidelines are having very minor difference in
the contents. The COFEPRIS guidelines are much more focused on the risk
assessment on all the quality management functions.
The contents of the Mexican health authority guideline (NOM
164 SSA1 2015) are descried below-
0.
Introduction.
1.
Objective and field of application.
2.
References.
3.
Definitions.
4.
Symbols and abbreviations.
5.
Quality Management System
6.
Quality Risk Management.
7.
Personnel
8.
Facilities and equipment.
9.
Qualification and Validation.
10.
Production systems.
11.
Quality Control Laboratory.
12.
Product Recall
13.
Outsourced Activities
14.
Destruction and final disposal of
waste
15.
Distributors
16.
Manufacture of drug substances for use
in clinical studies.
17.
Compliance with international and
Mexican standards.
18.
Bibliography
19.
Observance.
20.
Validity. 20.1 Normative
appendix A. Manufacturing areas classification.
20.2 Normative appendix B. Annual Product Review
The contents of the Mexican health authority guideline (NOM
159 SSA1 2016) are descried below-
1. Objective and application field.
2. References.
3. Definitions.
4. Symbols and abbreviations.
5. Quality Management System.
6. Quality Risks Management.
7. Personnel.
8. Facilities and equipment.
9. Qualification and validation.
10. Manufacturing systems.
11. Quality Control Laboratory.
12. Finished product release.
13. Market Product Recall.
14. Subcontracted activities.
15. Wastes Final Destination.
16. Good Storage and Distributions
Practices.
17. Agreement with international and
Mexican standards.
18. Bibliography.
19. Compliance.
20. Validity
21. Appendixes.
21.1. Normative Appendix A. Manufacturing
Areas Classification.
21.2. Normative Appendix B. Product Annual
Checking.
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