Pharmaceutical Quality System – EU GMP
EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use
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Guidelines
SCHEDULE M-II
Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Cosmetics
SCHEDUE M-I
Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Homoeopathic Medicines
SCHEDULE M – GMP – PART 7 (API-BULK DRUGS)
GOOD MANUFACTURING PRACTICES FOR ACTIVE PHARMACEUTIAL INGREDIENTS-API (BULK DRUGS)
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SCHEDULE M – GMP – PART 6 (METERED-DOSE-INHALERS)
GOOD MANUFACTURING PRACTICES FOR METERED-DOSE-INHALERS (MDI)
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SCHEDULE M – GMP – PART 5 (TOPICAL PRODUCTS)
GOOD MANUFACTURING PRACTICES FOR TOPICAL PRODUCTS i.e. EXTERNAL PREPARATIONS (CREAMS, OINTMENTS, PASTES, MULSIONS, LOTIONS, SOLUTIONS, DUSTING POWDERS AND IDENTICAL PRODUCTS)
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SCHEDULE M – GMP – PART 4 (ORAL LIQUIDS)
GOOD MANUFACTURING PRACTICES FOR ORAL LIQUIDS (SYRUPS, ELIXIRS, EMULSIONS AND SUSPENSIONS)
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SCHEDULE M – GMP – PART 3 (PARENTERAL PREPARATIONS)
GOOD MANUFACTURING PRACTICES FOR STERILE PRODUCTS, PARENTERAL PREPARATIONS (SMALL VOLUME INJECTABLES AND LARGE VOLUME PARENTERALS) AND STERILE OPHTHALMIC PREPARATIONS.
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SCHEDULE M – GMP – PART 2 (OSD)
GOOD MANUFACTURING PRACTICES FOR ORAL SOLID DOSAGE FORMS (TABLETS AND CAPSULES)
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Data Integrity – ALCOA+
Data integrity is the fundamental principle of ensuring that data is accurate, reliable, and consistent throughout its entire lifecycle.
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