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Pharmaceutical Quality/Manufacturing Standards (CGMP)- US FDA

Below is a sortable listing of Pharmaceutical Quality/Manufacturing Standards (CGMP) Guidances                          CATEGORY                             TITLE Pharmaceutical Quality/Manufacturing Standards (CGMP) COMPRESSED MEDICAL GASES GUIDELINE Compliance; Pharmaceutical Quality/Manufacturing Standards (CGMP) Contract Manufacturing Arrangements for Drugs: Quality Agreements (PDF - 123KB) Pharmaceutical Quality/Manufacturing Standards (CGMP) Current...

Pharma Regulations and Guidelines-India, Easy Access Links

(1). Regulations & Guidelines:              CDSCO    Central Drugs Standard Control Organization (CDSCO), under MOHFW (Ministry of Health & Family Welfare), Government of India - provides information about Drug & Medical Devices regulatory requirements in India.             NPPA   Drugs...

PIC/S [Pharmaceutical Inspection Convention and Pharmaceutical Inspection Scheme]- Guidelines & Links

                        All    Reference    Category  Section AIDE MEMOIRE ON ASSESSMENT OF QUALITY RISK MANAGEMENT (QRM) IMPLEMENTATION       PI 038-1 Documents for Inspectors Aide-Memoires AIDE MEMOIRE ON GMP PARTICULARITIES FOR CLINICAL TRIAL PRODUCTS        PI 021-2 Documents for Inspectors Aide-Memoires AIDE MEMOIRE ON INSPECTION OF BIOTECH      ...

REQUIREMENTS OF FACTORY PREMISES FOR MANUFACTURE OF MEDICAL DEVICES

(A). GENERAL REQUIREMENTS: (i) Location and surroundings: The factory building(s) shall be located in a sanitary place and hygienic conditions shall be maintained in the premises. Premises shall be not used for residence or be...

REQUIREMENT OF FACTORY PREMISES FOR MANUFACTURE OF COSMETICS.

A. GENERAL REQUIREMENTS: (a). Location and surroundings: The factory shall be located in a sanitary place and hygienic conditions shall be maintained in the premises. Premises shall not be used for residence or be interconnected...

SCHEDULE M-I

A. Requirements of factory premises for manufacture of Homoeopathic preparations: (1). Location and surroundings: The factory shall be situated in a place which shall not be adjacent to an open sewage drain, public lavatory or...

SPECIFIC REQUIREMENTS OF PREMISES, PLANT AND MATERIALS FOR MANUFACTURE OF ACTIVE PHARMACEUTICAL INGREDIENTS (BULK DRUGS)

A. Building and Civil Works:- (1). Apart from the building requirements contained Part-I, General note, the active pharmaceutical ingredients facilities for manufacture of hazardous reactions, Beta- Lactum antibiotics. Steroids and Steroidal Hormones / Cytotoxic substances...

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