Sampling and testing of Sterile surgical Gloves

Sampling and testing of Sterile surgical Gloves Objective: To lay down the procedure for Sampling and testing of sterile surgical gloves. Scope: This SOP is applicable for sampling and testing of sterile surgical gloves. Responsibility: Personnel (Microbiology-QC) shall be responsible for sampling and testing of sterile surgical gloves. Executive/ Officer shall be responsible for ensuring … Read more

Procedure for Operation & Calibration of  pH Meter

STANDARD OPERATING PROCEDURE Title : Procedure for Operation & Calibration of  pH Meter      OBJECTIVE This SOP describes the procedure for operation and calibration of pH Meter. SCOPE This procedure is applicable for operation and calibration of pH Meter in Quality Control Department. RESPONSIBILITY Officer / Executive-QC – responsible for Implementation of SOP. ACCOUNTABILITY … Read more

Procedure for Preparation, Standardization and Re-Standardization of Volumetric solutions

STANDARD OPERATING PROCEDURE Title : Procedure for Preparation, Standardization and Re-Standardization of Volumetric solutions         OBJECTIVE This SOP describes the procedure for Preparation, Standardization and Re-Standardization of Volumetric solutions. SCOPE This procedure is applicable for preparation and standardization of volumetric solutions in Quality Control. RESPONSIBILITY Officer / Executive-QC – responsible for Implementation of … Read more

Quality Management Review

Quality Management Review Objective To lay down a procedure for Quality Management. Scope This Standard Operating Procedure shall apply to formulation plant of Pharma Company. Responsibility Head Quality Assurance shall be responsible for compliance of this SOP. Heads of Production, QC, Stores, Engineering, and Human Resource etc. shall be responsible for implementation and compliance of … Read more

Procedure For Internal Facility Audit

STANDARD OPERATING PROCEDURE Title : Procedure For Internal Facility Audit    OBJECTIVE To lay down the procedure for carrying out Self Inspection of various departments. SCOPE This procedure is applicable for carrying out the self inspection of all departments RESPONSIBILITY It is a joint responsibility of all self-inspection team members in coordination with Quality Assurance. … Read more

Cleaning of SS Trolleys, Pallets and Racks

Cleaning of  SS Trolleys, Pallets and Racks Objective To lay down a procedure for cleaning of SS Trolleys, Pallets and Racks Scope This SOP is applicable for cleaning of SS Trolleys, Pallets and Racks in Raw Material Store/packing material/finished good at formulation plant of  Pharma Company. Responsibility Store personnel shall be responsible to follow the … Read more

Operation and Cleaning of Refrigerator

Operation and Cleaning of Refrigerator Objective To lay down a procedure for Operation and Cleaning of Refrigerator in Raw Material Store. Scope This Standard Operating Procedure is applicable for operation and cleaning of Refrigerator in Raw Material Store at formulation plant of  Pharma Company. Responsibility Raw material Store personnel shall be responsible to follow the … Read more

Handling of Fallen off / Damaged Status labels

Handling of Fallen off / Damaged Status labels Objective To lay down a procedure for Handling of Fallen off / Damaged Status labels. Scope This Standard Operating Procedure is applicable for Handling of Fallen off / Damaged Status labels of Raw Material /Packing material at formulation plant of Pharma Company. Responsibility Concerned Department personnel shall … Read more

MFR of Azithromycin 250 Tablets IP

MFR of Azithromycin 250 Tablets IP TABLE OF CONTENTS  S.NO. TITLE Page No. 1.0 PRODUCT DETAILS 2.0 MANUFACTURING FORMULA 3.0 LIST OF EQUIPMENTS 4.0 GENERAL PRECAUTIONS 5.0 MANUFACTURING INSTRUCTIONS 6.0       MANUFACTURING PROCESS DETAILS 6.1 GRANULATION 6.2 COMPRESSION 6.3 COATING 6.4 BRAND DETAILS  1.0 PRODUCT DETAILS: Product Name Azithromycin Tablets IP Product Description … Read more

MFR of Deflazacort Tablets

MFR of Deflazacort  Tablets TABLE OF CONTENTS  S.NO. TITLE Page No. 1.0 PRODUCT DETAILS 2.0 MANUFACTURING FORMULA 3.0 LIST OF EQUIPMENTS 4.0 GENERAL PRECAUTIONS 5.0 MANUFACTURING INSTRUCTIONS 6.0       MANUFACTURING PROCESS DETAILS 6.1 GRANULATION 6.2 COMPRESSION  1.0 PRODUCT DETAILS: Product Name Deflazacort  Tablets Product Description White color round shape, uncoated tablet having one … Read more