WHO Good Manufacturing Practices (WHO-GMP) for Pharmaceutical products: Key Points
WHO Good Manufacturing Practices (WHO-GMP) for Pharmaceutical products: Key Points
CGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the CGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories. This formal system of controls at a pharmaceutical company, if adequately put into practice, helps to prevent instances of contamination, mix-ups, deviations, failures, and errors. This assures that drug products meet their quality standards.
- Design of the Facility-Uniflow
- Validation of The Process
- Good Documentation Practices -Write good procedures and follow them (SOPS & STPS)
- Define Roles & Responsibilities -Identify who does what.
- Good Record Keeping (Archiving)
- Practice good hygiene
- Training & development of the staff at regular intervals
- Perform regular audits (Internal audits, vendor audits etc)
http://www.who.int/medicines/areas/quality_safety/quality_assurance/TRS986annex2.pdf
http://www.who.int/medicines/areas/quality_safety/quality_assurance/gmp/en/
http://www.who.int/medicines/areas/quality_safety/quality_assurance/QualityAssurancePharmVol2.pdf
http://www.cdsco.nic.in/writereaddata/GMP%20Checklist.pdf
http://www.cdsco.nic.in/writereaddata/ScheduleM(GMP)6.pdf
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