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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