Organogram in Pharma Industry in Pharma Industry Objective To describe the procedure for preparation of Organogram in Pharma Industry. Scope This procedure is applicable for preparation of organograms of all the departments in Pharma Industry. Responsibility P&A Department is responsible for preparation of organogram. Head – User department is responsible for review of respective Organograms….
Cleaning Policy of Area and Equipment in Pharma Industry Objective To lay down the procedure for Cleaning Policy of Area & Equipment in Pharma Industry. Scope This Standard Operating Procedure is applicable to all the departments at the formulation plant in Pharma Industry. Responsibility Production Operator/ Technician shall be responsible for cleaning. Production &…
Read More “Cleaning Policy of Area and Equipment in Pharma Industry” »
STANDARD OPERATING PROCEDURE Title : Procedure for autoclave validation Department : Quality Control-Microbiology OBJECTIVE To lay down a procedure for autoclave validation. SCOPE This SOP is applicable for autoclave validation in microbiology laboratory . RESPONSIBILITY Officer / Executive-QC – responsible for Implementation of SOP. ACCOUNTABILITY Manager – Quality Control PROCEDURE…
STANDARD OPERATING PROCEDURE Title : Procedure For Dispensing of Packing Materials OBJECTIVE This SOP describes the procedure for dispensing of packing material. SCOPE This procedure is applicable to Warehouse department for dispensing of packing material. RESPONSIBILITY Officer / Executive-WH – responsible for Implementation of SOP. ACCOUNTABILITY Manager-Warehouse PROCEDURE After receiving batch requisition from…
PURPOSE: This MFR is written to describe the formulae, manufacturing procedure, specifications, packing details of dosage form. SCOPE: This procedure is performed and is applied during the manufacturing of dosage form. RESPONSIBILITY / ACCOUNTABILITY: It is the responsibility of Assistant Manufacturing Chemist to follow and adhere to this MFR. The Production Pharmacist, QC/QA Manager are accountable…
STANDARD OPERATING PROCEDURE Title : Procedure For Handling of Market Complaints OBJECTIVE To lay down the Procedure for Handling of Market Complaints. SCOPE This Procedure is applicable for handling of market complaints received from wholesaler, Distributor, Retailer, Customer, Physicians, Patients, field staff etc. at Pharmaceutical Company. RESPONSIBILITY It is a joint responsibility of Manager-Marketing and Manager-Quality Assurance in coordination with Quality Assurance. It is a…
Chlorzoxazone ,Nimesulide Tablet PURPOSE: This Master formula record (MFR) is written to describe the formulae, manufacturing procedure, specifications, packing details of dosage form. SCOPE: This MFR is performed and is applied during the manufacturing of dosage form. RESPONSIBILITY / ACCOUNTABILITY: It is the responsibility of Manufacturing Chemist to follow and adhere to this SOP. The…
STANDARD OPERATING PROCEDURE Title : Procedure For the handling of rejected material Department: Quality Assurance OBJECTIVE To lay down a procedure for defining the handling of rejected material. SCOPE This procedure is applicable for segregation the rejected material such as primary and secondary packaging material, raw material, and any type of finished product….
Read More “Procedure For the handling of rejected material” »
STANDARD OPERATING PROCEDURE Title Procedure For BMR, BPR Review and Release OBJECTIVE To define the procedure for review of the Batch Manufacturing Record and Batch Packing Record. SCOPE This procedure applies to Quality Assurance Department. RESPONSIBILITY Officer / Executive – Quality Assurance ACCOUNTABILITY Manager – Quality Assurance PROCEDURE Executive – Production to review and ensure…
STANDARD OPERATING PROCEDURE Title : Procedure For Deviation control system Department: Quality Assurance OBJECTIVE To lay down the procedure for reporting and monitoring of deviations that occur during receipt and storage of material, manufacturing process of a product, testing and release of material/product, documented procedures wherever applicable. SCOPE This Procedure is applicable to all related…
