Production

Flow Chart and Manufacturing Procedure of Nimesulide Tablets Bill of Materials Ingredient Pharmacopoeial Status Pharmaceutical role Nimesulide Ph.Eur Active Lactose Monohydrate Ph.Eur. Diluent Croscarmellose Sodium Ph.Eur Disintegrant Silica, Colloidal Anhydrous Ph.Eur. Glidant Maize Starch Ph.Eur Diluent Povidone (K-30) Ph.Eur. Binder Docusate Sodium Ph.Eur. Surfactant Polysorbate 80 Ph.Eur. Surfactant Hydrochloric Acid,Concentrated …

 Manufacturing Procedure of Ornidazole Tablets   Bill of Material Ingredient Pharmaceutical role Ornidazole Active Microcrystalline Cellulose Diluent Lactose Monohydrate Diluent Silica, Colloidal Anhydrous Surfactant Povidone (K-30) Binder Water, Purified Vehicle Sodium Lauryl sulphate Surfactant Talc Granular former Magnesium Stearate Lubricant Croscarmellose Sodium Disintegrating Opadry Green Coloring Agent Manufacturing Procedure  Step …

MANUFACTURING PROCESS FLOW CHART (Coated tablets)     Thank you for visit and for more pharma updates click here – https://pharmaguidances.com

MANUFACTURING PROCESS FLOW CHART (Uncoated tablets)   Thank you for visit and for more pharma updates click here – https://pharmaguidances.com  

Manufacturing Procedure of Metformin Hydrochloride Extended-Release Tablets USP 1000 mg     Bill of Material: Batch Size:- 100000 Tablets Ingredient Standard Quantity  Per batch In kg METFORMIN HYDROCHLORIDE 100.60* CARMELLOSE SODIUM 10.00 PURIFIED WATER 18.60 HYPROMELLOSE 26.00 CELLULOSE,MICROCRYSTALLINE (DIRECTLY  COMPRESSIBLE,PH 102) 9.5 MAGNESIUM STEARATE 1.5 POVIDONE 1.5 SILICA , COLLOIDAL .ANHYDROUS 1.5 …

Validation of Sterilization Process in Autoclave VALIDATION PROTOCOL      Validation of Sterilization  Process in Autoclave (Loaded chamber)  Purpose : To provide the procedures to be followed for study of heat  distribution studies in loaded chamber of Autoclave.  Scope :  This procedure is applies to all Autoclaves used to sterilize Containers or Equipment’s used …

Procedure for measurement of fill weight during batch filling Objective: To lay down the procedure for measurement of fill weight during batch filling. Scope: This SOP is applicable for measurement of fill weight during batch filling in Injectable department. Responsibility: Operators/Technician – Responsible for measurement of fill weight during batch …

SOP for operation of Metal Detector for automatic capsule filling machine Objective: To lay down a procedure for operation of metal detector. Scope: This SOP is applicable for the operation of metal detector to the formulation plant of  PHARMACEUTICAL Company. Responsibility: Production Operator/ Technician – For operation of the machine. …

SOP on operation and cleaning of analytical balance used in aseptic area (Sartorious) Objective: To lay down a procedure for operation and cleaning of analytical balance used in the aseptic area (Make: Sartorious). Scope The SOP describes the procedure for operation and cleaning of analytical balance used in the aseptic …

Human interventions in aseptic processing It is appropriate to focus on human interventions performed during aseptic processing because no other factor has the same potential for introducing contamination. Sterilization processes, environmental sanitization, room design, and heating and ventilation systems are all substantially less significant as sources of contamination. Personnel continuously shed microorganisms and particles to …

Objective To lay down the procedure for storage of sterilized rubber stoppers in aseptic area. Scope This SOP is applicable for storage procedure of sterilized rubber stoppers in aseptic area Production dry powder Injectable facility. Responsibility Production officer / Executive. Accountability Production Head shall be accountable for the compliance of …

OBJECTIVE : To outline the procedure for the Packaging Area/Line clearance before the start up of any packaging operation, to ensure that the packaging area/line has been thoroughly  cleaned  and  that  all  coded labeling   and   packaging  materials of the previous batch/product have been completely removed. RESPONSIBILITY : Officer – Production  …

Objective The SOP describes cleaning procedure for footwear used in production area. Scope This SOP is applicable for the cleaning procedure for footwear used in production area. Responsibility Production Officers / Executive. Accountability Production Head shall be accountable for the compliance of SOP. Abbreviations IPA  :  Isopropyl alcohol Description Cleaning …

Objective To lay down the procedure for operation, cleaning and maintenance of Fogger. Scope This SOP is applicable for the operation, cleaning and maintenance of Fogger used in the Aseptic area of Sterile Injectable Facility. Responsibility Production officer / Executive. Accountability Production Head shall be accountable for compliance of SOP. …

Objective: To lay down a procedure for sterilization of vial filling and bunging machine parts. Scope This SOP is applicable for sterilization of vial filling and bunging machine parts. Responsibility Production Officers/ Executive. Accountability Production Head shall be accountable for the compliance of SOP. Abbreviations SOP : Standard Operating Procedure. …

Objective: To lay down a procedure for operation of vacuum leak test Scope: This SOP is applicable for operation of vacuum leak test. Responsibility: Production Officers / Executive. Accountability: Production Head shall be accountable for the compliance of SOP. Abbreviations SOP : Standard Operating Procedure MMI : Man Machine Interface …

Objective: To lay down a procedure for cleaning of the pre-filters of LAF Unit, garment cubicle, dynamic pass box. Scope This SOP is applicable for cleaning of pre-filters of LAF Unit, garment cubicle, dynamic pass box. Responsibility Production Officers / Executive. Accountability Production Head shall be accountable for the compliance …

Objective: To lay down a procedure for Disposal of rejected primary & secondary packing materials. Scope This SOP is applicable on procedure for Disposal of rejected primary & secondary packing materials for Production dry powder Injection facility. Responsibility Officers or above – Production. Accountability Production Head. Abbreviations SOP : Standard …

Objective: To lay down a procedure on assembly of cartridge filter in housing. Scope This SOP is applicable for assembly of cartridge filter in housing. Responsibility Officers or above – Production. Accountability Production Head. Abbreviations SOP : Standard Operating Procedure. WFI : Water For Injection Procedure Close the valve of …

Objective: To lay down a procedure for collection and disposal of waste & rejected material from plant. Scope: This SOP is applicable for collection and disposal of waste & rejected material from plant. Responsibility: Officers or above – Production. Accountability: Production Head. Abbreviations SOP : Standard Operating Procedure. S.S. : …