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…
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….
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…
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….
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…
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….
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…
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…
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,…
Metformin Hydrochloride Tablet 500 mg: A Comprehensive Guide Metformin hydrochloride is a widely prescribed medication used to manage type 2 diabetes mellitus. It belongs to the class of drugs known as biguanides and is known for its effectiveness in controlling blood glucose levels. Metformin hydrochloride tablets in the 500 mg strength are commonly prescribed due…
