Lesson9: Basis of quality control process Flashcards
why QM is important in pharmaceutical industries ?
QM is very important for pharmaceutical industries
- to produce the better product,
- to improve quality at every level,
- to ensure the maximum safety of health care system and
- protect waste of money both government and individual
customers.
Role of QM ?
QM ensures that every employee is working towards the improvement of work, processes, services, systems, and so on for long term success.
To be successful in implementing of QM, what are the element keys organization should concentrate on ?
To be successful implementing of QM, an organization must concentrate on the key elements such as Ethics, Integrity, Trust, Training, Teamwork, Leadership, Recognition, Communication.
What are the principle of QM approach ?
The principles of the QM approach are follows:
▪ Focus on the customer
▪ Employee involvement
▪ Process-centered
▪ Integrated system
▪ Strategic and systematic approach
▪ Continuous improvement
▪ Fast-based decision making
▪ Communications
What’s QA department responsible for?
QA department is responsible for ensuring that the quality polices adopted by a company are followed.
Principles of QA ?
The principles of QA are following:
▪ Wide-ranging concept: covers all matters that individually or collectively
influence the quality of a product
▪ Totality of the arrangement: ensure that the drug is of the right quality for the intended use
▪ QA incorporates GMP
How QA act as key personnel ?
QA acts as key personnel
▪ Product design and development: authorize the document, vendor evaluation,
vendor audit
▪ Manufacturing process: environment monitoring, qualification, calibration, validation, in process control, product disposition
▪ Post production: stability test, retained sample, returned product, product compliant, recall
▪ Compliance: QM system manual/site master file, change control, deviation, audit, training, documentation, risk management, product quality review
What is QC ?
Quality Control (QC) is an essential operation of the pharmaceutical industry.
What are the main responsibilities of QC ?
The main responsibilities of QC in pharmaceutical industry included: efficacy, safety, quality, compliance.
តើក្រុមហ៊ុនផលិតឱសថផ្តោតសំខាន់លើអ្វីខ្លះ ?
Validation, Qualification, Calibration
What is the requirement of GMP for QC ?
Requirement of GMP for QC means that test methods are validated.
What are the main components of QC ?
The main components of QC are sampling, validation, records, batch inspection and sampling, QC labs, retained samples, analysis of finished product.
