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Wednesday, December 21, 2022

WHO Good Manufacturing Practices Guidelines for Pharmaceutical

What are GMP guidelines ? WHO the world pharmaceutical manufacturers health organization, United states of America’s food and drugs administration, and various other medical and drug regulatory agencies across globe, provide advisory to the pharmaceutical manufacturers for manufacturing of the medicines drug products which are supposed to be used by the citizens of their country, the advisory is called as Good Manufacturing Practices Guidelines GMP guidelines for pharmaceutical manufacturers, these guidelines keep on getting updated with time with revisions to include newer things, and whenever the updating occurs these guidelines supersedes earlier issued guidelines therefore they are called as c GMP guidelines. C stands for current, means latest. 

Good manufacturing practices are procedures adapted to ensure that the pharmaceuticals manufactured meets the desired quality and standards as specified. Good manufacturing guidelines of many regulatory agencies are combined and harmonization is done for providing one globally acceptable guidelines by all regulatory agencies and Food and drugs administrations and pharmaceutical manufacturers. One such platform is International Council for harmonization (ICH), ICH compile technical guidelines mandatory requirements from various regulatory agencies FDAs across the world and make one document of technical guidelines and the same is accepted by the regulatory agencies, FDA’s and Associations of Pharmaceutical Manufacturers across the world. 

What is basic of Good Manufacturing Practices Guidelines. How many types of pharma guidelines are there? 
Agencies issue guidelines on following process and procedures. Below topics are covered in to Guidelines provided to Pharmaceutical manufacturers. 

1. Prevention of cross contamination arising from environment, premises personnel’s. For prevention of cross contaminations, requirements of building, personnel movements, gowning procedures, and HVAC systems equipped with high efficiency particulate filters, and controlled areas, clean room. Process controls, Pharma Process Validation Cleaning, and Cleaning validations. 

2. Quality assurance aspects, risk assessments, addressing the issues efficiently and honestly through reporting and addressing deviations, incidences, market complaints through efficient corrective and preventive actions, objective oriented handling of quality systems by management, continuous improvisation and eliminating the noncompliance through training and upgrading systems and personnel. Internal audits and controls. 
 
3. Quality control, of the product by analysis of raw and finished products and their intermediates, packing materials, so that the quality of product is meet. Good laboratory practices. Validations of methods used for testing of pharmaceutical products, reporting of Out of Standard, Out of trend observations, investigations and their mitigations. 

4. Risk assessments. 
5. Pharmacovigilance. 
6. New drug development. 
7. Clinical Evaluation of new drugs. 
8. Active pharmaceutical Ingredient manufacturing. 
9. Development 
10. Production 
 11. Quality control 
 12. Quality assurance 
 13. Inspections 
14. specific texts for prequalification of medicines.

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