Most relevant regulations for biomedical sector are included (Pharmaceutical, Veterinary, Biosecurity, Cosmetic or sanitary producs) in order to accomplish the requirements in a facility, project or production process. In case of being interested in having more details of the current legislation in a sector or having doubts for the proper interpretation do not hesitate to contact us we will help you: pharmasupport@ingelyt.com
We can also help bring your project to the most important regulatory agencies (AEMPS, EMA, FDA, Anvisa or any regulatory agency) for review and approval or clear any doubts about the regulatory agencies before or during the project.
We ensure that projects designed and implemented by Ingelyt conform to the current regulation in order for the facilities to be approved by different regulatory agencies for higher requirements markets, being able to perform all required documentation for its approval (technical report, Site Master File (SMF), qualifications of facilities and equipment, pharmaceutical plans, risk analysis, process validation protocols, simulation aseptic protocols (Media Fill), ….)
- Good Manufacturing Practices (GMP)
- Pharmaceutical Legislation
- Steril product legislation
- Cosmetic product legislation
- Biosecurity
1. Good Manufacturing Practices (GMP)
Good Manufacturing Practices (GMP) are the basic guidelines for defining quality standards in medicines manufaction. They are mandatory for the pharmaceutical industry.
- Europa (European Medicine Agency)(EMA)
- Good Manufacturing Practices AEMPS (Agencia Española del Medicamento y Productos Sanitarios)
Good manufacturing practices of AEMPS is the transposition of European current legislation.
http://www.aemps.gob.es/industria/inspeccionNCF/guiaNCF/home.htm - Normas de correcta fabricación EMA (European Medicine Agency)
- EudraLex – Volume 4 Good manufacturing practice (GMP) Guidelines (EMA)
- Good manufacturing practices common to all EU countries
http://ec.europa.eu/health/documents/eudralex/vol-4/index_en.htm
- Good Manufacturing Practices AEMPS (Agencia Española del Medicamento y Productos Sanitarios)
- United States (Food Drug administration) (FDA)
- 21 Code of Federal Regulations Part 210. Current Good Manufacturing Practice in Manufacturing Processing, packing, or Holding of Drugs
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=210.1 - 21 Code of Federal Regulations Part 211. Current Good Manufacturing Practice for Finished Pharmaceuticals
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=211
- 21 Code of Federal Regulations Part 210. Current Good Manufacturing Practice in Manufacturing Processing, packing, or Holding of Drugs
- World health organization (WHO)
- PIC/S (Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme )
- PIC/S GMP Guidehttp://www.picscheme.org/publication.php?id=4
2. 2. Pharmaceutical legislation
More relevant pharmaceutical international regulation in order to meet international requirements in facilities and manufacture of medicines
- ICH (International Conference harmonization)
The ICH (International Conference Harmonization) guidelines are standardized rules among the most important regulatory agencies (Europe, FDA and Japan) in order to guarantee common quality standards.- Q7 Good manufacturing practice guide for active pharmaceutical ingredients
http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q7/Step4/Q7_Guideline.pdf - Q9 Quality risk management
http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q9/Step4/Q9_Guideline.pdf
- Q7 Good manufacturing practice guide for active pharmaceutical ingredients
- PIC/S (Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme)
- http://www.picscheme.org/publication.php?id=4
- Explanatory notes for pharmaceutical manufacturers on the preparation of a site master file PE 008-4
- Validation master plan installation and operational qualification non-sterile process
- Validation cleaning validation PI 006-3
- Validation of aseptic processes PI 007-6
- World health organization (WHO)
- Inspections guidelines
http://www.who.int/medicines/areas/quality_safety/quality_assurance/inspections/en - Production guidelines
http://www.who.int/medicines/areas/quality_safety/quality_assurance/production/en/
- Inspections guidelines
Steril products legislation
Sterile products as the risk that they suppose for the final user, have a specific regulation that must be met by the different manufacturers.
The most relevant pharmaceutical international Regulations in order to meet international requirements in manufacture of sterile products.
- Eudralex Vol. 4 (EU GMP) Annex 1 “Guideline for the manufacture of sterile medicine products.”
http://ec.europa.eu/health/files/eudralex/vol-4/2008_11_25_gmp-an1_en.pdf - PICS PI007-6 Recommendation on the validation of septic processes
http://www.picscheme.org/pdf/26_pi007-6recommendationonasepticprocesses.pdf - FDA Guidance sterile drug products produced by aseptic processes
http://www.fda.gov/downloads/Drugs/…/Guidances/ucm070342.pdf - ISO13408 Aseptic processing of health care products general requeriments
http://www.iso.org/iso/search.htm?qt=13408&sort_by=rel&type=simple&published=on&active_tab=standards - PDA TR Nº 28 : process simulation testing for sterile bulk pharmaceutical chemicals
https://store.pda.org/TableOfContents/PDA_Technical_Reports_list.pdf - PDA TR Nº44 : Quality risk management for aseptic processes (2008)
https://store.pda.org/TableOfContents/PDA_Technical_Reports_list.pdf - PDA TR Nº22 Process simulation for aseptically filled products (2011)
https://store.pda.org/TableOfContents/PDA_Technical_Reports_list.pdf - PDA TR N62 : Recommended practices for manual aseptic processes
https://store.pda.org/TableOfContents/PDA_Technical_Reports_list.pdf
Cosmetic products legislation
Manufacture of cosmetic products has a specific legislation for the facilities and manufacturing processes of cosmetic products.
- Guides FDA relative to manufacture of cosmetics
http://www.fda.gov/Cosmetics/GuidanceRegulation/GuidanceDocuments/default.htm - Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:342:0059:0209:EN:PDF - ISO 22716:2007 Cosmetics GMP
http://www.iso.org/iso/catalogue_detail.htm?csnumber=36437
Biosecurity
The manipulation of living microorganisms needs a few specific requirements in the facilities destined for their manipulation shuch as investigation centers or manufacturers laboratories of biological origin medicines.
- Technical Guide for the evaluation and prevention of risks associated with exposure to biological agents (INSHT del Ministerio de Trabajo)/strong>
http://www.insht.es/InshtWeb/Contenidos/Normativa/GuiasTecnicas/Ficheros/agen_bio.pdf - Regulations of the CDC (Centers for disease control and prevention) of the United States of America (USA) concerning levels of control for different levels of biosecurity
http://www.cdc.gov/biosafety/publications/bmbl5/bmbl5_sect_iv.pdf - Canadian regulations (Laboratory Biosafety Guidelines)
http://www.phac-aspc.gc.ca/publicat/lbg-ldmbl-04/index-eng.php - Biosafety Guidelines of the World Health Organization (WHO), 2003
http://www.who.int/csr/resources/publications/biosafety/CDS_CSR_LYO_2004_11SP.pdf
En INGELYT estamos a la vanguardia y somos pioneros en el sector en cumplir con el Diseño, Implantación y Mantenimiento de Planes y Programas de Prevención y Gestion de Riesgos Legales y Penales (CORPORATE COMPLIANCE)