SOP on procurement and handling of working standards Objective:To lay down a procedure for the procurement and handling of working standards. Scope:This SOP is applicable for procurement and handling of working standards in quality control laboratory of pharmaceutical company name with location. Responsibility:Chemist or above of QC laboratory shall be responsible for follow the procedure … Read more
Objective:To lay down a procedure for preparation and standardization of volumetric solution. Scope:This SOP is applicable for preparation and standardization of volumetric solution in quality control laboratory in pharmaceutical company name with location. Responsibility: Officer or above of QC Laboratory is responsible for follow the procedure mentined in this SOP. Accountability:Head QC and QA shall … Read more
SOP on Procedure for sampling of raw material Objective:To lay down the procedure for sampling of raw material. Scope:This procedure is applicable for sampling of raw material in Pharmaceutical company name with location. Responsibility:QC Personal shall be responsible for follow the procedure mention this SOP. Accountability:QC and QA Head shall be accountable for implementation of … Read more
Objective:To lay down the procedure for calibration of laboratory glassware. Scope:This SOP is applicable for calibration of laboratory glassware in Quality Control Department at pharmaceutical company name with location. Responsibility:Chemist or above of QA shall be responsible to follow the procedure mentioned in this SOP. Accountability:Department Head & QA Head shall be accountable for implementation … Read more
SOP On Product Recall Objective :To lay down procedure for prompt and effective recall of finished products known or suspected to be defective, from domestic and export market. Scope:This Standard Operating Procedure is applicable to the product recall of the products manufactured at the formulation plant of Pharmaceutical (Company Name ). Responsibility: Quality Assurance :Decision … Read more
Sop on Corrective and Preventive Action Objective :To lay down a procedure for the Corrective and Preventive Action so as to eliminate the causes of potential non-conformities and /or encountered non-conformities in order to prevent their occurrence and / or recurrence. Scope :This Standard Operating Procedure shall apply to all corrective and preventive action taken … Read more
Sop on Recording of Specimen Signature Objective :To lay down the procedure to record the specimen signature. Scope:This Standard Operating Procedure is applicable for recording of specimen signature of all the personnel working at Pharmaceutical Company (Name). Responsibility Concerned personnel of all department shall be responsible for following the procedure written in the SOP. QA … Read more
Sop on handling-of-product-complaints Objective :To lay down a procedure to investigate, document and respond to the product complaints. Scope :This Standard Operating Procedure shall be applicable to all pharmaceutical drug products manufactured or marketed by (Pharmaceutical Company Name). Responsibility Head, Marketing shall be responsible for forwarding the complaints received from sales representatives, customers etc. to … Read more
SOP on Change Control Objective :To establish a procedure for controlling and documenting changes. Through the provisions of this procedure, a proposed change shall be evaluated and approved internally on its scientific merit and appropriate external authorization shall be sought for those changes that impact on regulatory submissions. Scope:This procedure shall apply to formulation plant … Read more
Sop on Assigning Manufacturing and Expiry date Objective:To lay down a procedure for assigning manufacturing and expiry date to the finished products being manufactured. Scope:This SOP is applicable for assigning manufacturing and expiry date to the finished products being manufactured at (Pharmaceutical Company Name). Responsibility Production Personnel shall be responsible for assigning manufacturing and … Read more