Validation Master Plan A manufacturer should have a VMP which reflects the key elements of validation. It should be concise…
COMPLAINTS AND RECALLS All quality related complaints, whether received orally or in writing, should be recorded and investigated according to…
BUILDINGS AND FACILITIES Design and Construction Buildings and facilities used in the manufacture of intermediates and APIs should be located,…
OBJECTIVE : The objectives of good manufacturing practices (GMP) include the prevention of possible contamination and cross-contamination of pharmaceutical starting…
Application of hazard analysis and critical control point (HACCP) methodology to pharmaceuticals. Hazard:- Any circumstance in the production, control, and…
SOP List for Pharmaceutical Quality Assurance. A list of Standard Operating Procedure for Pharmaceutical Quality Assurance Department required During Quality…
Operational Qualification (OQ) In Pharmaceuticals. Systems and equipment should operate correctly and their operation should be verified in accordance with…
Installation Qualification (IQ) Protocol and Report in Pharmaceuticals. Installation Qualification:- Systems and equipment should be correctly installed in accordance…
Training of employees PROCEDURE: Every employee of the organisation shall first undergo an Induction Training and then to be…