SOP for QMS Tools Document Management –Review batch records, stability reports, validation reports, and associated documents required to comply with respective regulatory country GMP. Site Deviations – initiation, investigation, review, closeout, and maintenance for internal and external issues. Change Controls – initiation, review, closeout, and maintenance of all internal and external change controls. CAPA Management – manages … Read more
VALIDATION OF FREEZE DRYER “In freeze-drying, water is removed from the frozen state by sublimation, i.e., direct change of water from solid into vapor without conversion to a liquid phase”. Used for drying of a no. of products. Especially, Blood plasma and its fractionated products. Bacterial and viral cultures. Human tissues. Antibiotics and plant extracts. … Read more
Procedure For Annual Product Quality Review STANDARD OPERATING PROCEDURE Title : Procedure For Annual Product Quality Review OBJECTIVE To lay down a procedure for Annual Product Quality Review. SCOPE This procedure is applicable to Quality Assurance Department for annual product review of finished products . RESPONSIBILITY Executive-Quality Assurance ACCOUNTABILITY Manager-Quality Assurance VP – Plant … Read more
Procedure For Product Recall STANDARD OPERATING PROCEDURE Title : Procedure For Product Recall OBJECTIVE To lay down the Procedure for product recall. SCOPE This Procedure is applicable for Handling of Product Recalls at Pharmaceutical Company. RESPONSIBILITY It is a Joint responsibility of the Marketing Department in coordination with Quality Assurance Head-Export / Company Appointed Business agent of the country in coordination with Quality Assurance. Manager – Quality Assurance ACCOUNTABILITY Manager-QA VP-Plant & Operations. … Read more
Ferrous Fumerate I.P. 300 mg PURPOSE: This Standard Operating Procedure 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 SOP. … Read more
Lansoprazole U.S.P. 30 mg PURPOSE: This Standard Operating Procedure 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 SOP. The Production … Read more
Ginseng Powder 200 mg PURPOSE: This Standard Operating Procedure 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 SOP. … Read more
Omeprazole 40 mg PURPOSE: This Standard Operating Procedure 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 SOP. The Production … Read more
Pantoprazole Sodium Sesquihydrate PURPOSE: This Standard Operating Procedure 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 SOP. The … Read more
Norethisterone 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 Production Pharmacist, … Read more