Quality management system in a pharmaceutical manufacturing company
What is quality management system QMS in pharma company?
Following functions all together when driven together forms, every function is more or less interlinked or impacting other, therefore systematic operating of every function is important to achieve compliance and quality aspects as defined in guidelines of regulatory agencies across the world.
- Training of personnel. Through accepted approved guidelines and presentations and SOPS.
- On job trainings, process training.
- Standard operating procedures and their training, periodic revisions and updating.
- Training for new equipment after qualification and installation process validation training.
- Batch manufacturing records keeping master copies updated.
- Batch packing records keeping master copies updated.
- Validation master Plan
- Site master file, drug master files.
- Issuing and maintain log books and formats.
- Risk assessment. For every department in pharma manufacturing company risk assessments are required to be done a ready reference for mitigation strategy is required to be in place.
- Mitigation strategies.
- Reporting logging and handling of Deviation, Deviation management.
- Reporting logging and Investigations of Incidences.
- Change Management through Change control, filing of change control, evaluating the impact of change control, approval of change control, implementation and closing of change control through proper action plans.
- Corrective and preventive actions.
- Review and approve the reports and records.
- Monitor functions and impart continuous trainings to Inproces Quality Assurance.
- Handling of market complaints
- Conducting investigations of
- Out of specification results their investigation and root cause analysis.
- Out of Trend Results
- Prepare and evaluate annual product quality review reports.
- Internal Audits, implementation of learnings from internal audit CAPA.
- Management reviews. Period review of Key performance indicators of a quality assurance and production development and laboratory functions by higher management and deciding up on the major requirements and changes and corrective actions preventive actions implemented and planned actions.
Definition of Drug and different Drugs