At EU-level there are not fixed rules about how risk assessments should be undertaken (you should check the specific legislation…
CAPA (Corrective Action & Preventive Action) is an area that we talk about often, mainly because it’s still such a…
Principle. All complaints and other information concerning potentially defective products should be carefully reviewed according to written procedures and the…
The purpose of this Standard Operating Procedure (SOP) is to lay down the procedure for defining job responsibilities of individuals.…
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…