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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      ...

Bacteriology: Specimen Collection, Transport & Processing

A. Blood: (1). Collection and transport Purpose: To reduce blood culture contamination rate, collection may be improved by taking the following precautions. Note: This is an emergency procedure. The sample has to be processed and reported immediately. The...

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...

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...

REQUIREMENTS OF PLANT AND EQUIPMENT – PART-II

A. External Preparations:- The following equipments are recommended for the manufacture of External preparations (Ointments, Emulsion, Lotions, Solutions, Pastes, Creams, Dusting powders and such identical products) used for external applications and their associated equipments...

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...

SPECIFIC REQUIREMENTS FOR MANUFACTURE OF METERED-DOSE-INHALERS(MDI)

Manufacture of Metered-Dose-Inhalers shall be done under conditions which shall ensure minimum microbial and particulate contamination. Assurance of the quality of components and the bulk product is very important. Where medicaments are in suspended...

SPECIFIC REQUIREMENTS FOR MANUFACTURE OF TOPICAL PRODUCTS

Note: - External preparations (Creams, Ointments, Pastes, Emulsions, Lotions, Solutions, Dusting powders and identical products used for external applications). In addition to these requirements, following Specific Requirements shall also be followed; (1). The entrance to the...

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