Quality Assurance (QA)
Concept of quality assurance:
Quality assurance is wide ranging concept, covering all matters that individually or collectively influence the quality of product. It is totally of the arrangements made with the object of ensuring that pharmaceutical products are of the quality required for their intended use. Quality assurance (QA) therefore incorporates good manufacturing practices (GMP) and other factors, such as product design and development.
Responsibility of quality assurance:
To insure that pharmaceutical products are designed and developed in a way that takes account of the requirements of good manufacturing practices (GMP) and other associated codes such as good laboratory practices (GLP) & good clinical research practices (GCP)
To ensure production and control operation are clearly specified in written form and GMP requirements are adopted. Managerial responsibilities are clearly specified in job descriptions. Arrangements are made for the manufacture, supply and use of the correct starting & packaging material. Satisfactory arrangement exists to ensure, as far as possible that the pharmaceutical products are stored by the manufacture, distributed and subsequently handled so that quality is maintained throughout their shelf life. There is a procedure for self inspection and quality audit that regularly appraises the effectiveness and applicability of the quality assurance systems. The manufacturer must assume responsibility for quality of the products and to ensure that they are fit for their intended use.
To achieve the quality objective reliably there must be comprehensively design and correctly implemented system of quality assurance incorporating GMP and quality control. It should be fully documented and effectiveness monitored. All parts of quality assurance system should be adequately staffed with competent personnel and should have suitable and sufficient premises, equipment and facilities.
- Every organization has a quality policy it is always kept at first level.
- Second level are administrative procedures or commitment documents such as site master file, validation master plan, cleaning validation master plan, and other commitment documents.
- Third level there are documents which are derived from commitment level documents like SOPs protocols work instructions master batch records etc.
Aim of Quality assurance:
- Continuous quality improvement
- Bench-marking to to generate ideas for quality improvement
- Meet quality standards for the product
- Compliance with statutory and safety regulations
- Ensure total traceability product
- Stability of products to customer requirement
Key elements of quality assurance:
- Quality policy
- Quality manual
- Validation master plan
- Quality risk management
- Site master file
- System SOPs
- Internal auditing systems
- GMP Review systems
- Process/cleaning/method/computer system/personnel validation
- Vendor qualification and evaluation
- Qualification of equipment
- Calibration of instruments
- management of change
- Deviation handling
- Market complaint & product recall
- Product quality review
- Document control
- Training (On job, class room, induction, external)
- Master batch records
Attributes of quality assurance personnel:
- Good knowledge, expertise about industry, skill over all processes
- Must be objective
- Must be unprejudiced
- Must be consummated
- Must have problem solving skills
- Must have sound technical knowledge
- Must be vigilant
- Must know all the industry standards and regulations
Additional information: (Question &Answer)
Question: What is Quality.?
Answer: It is the totality of features and characteristics of a product or service that bear on its ability to satisfy stated or implied needs.
Question: What is Assurance.?
Answer: Act of giving confidence, the state of being certain or the act of making certain.
Question: What is Quality assurance.?
Answer: Quality assurance is the sum total of organized arrangements made with the object of ensuring that product will be the quality required by intended use.
Question: What is Quality control
Answer: Quality control is that part of GMP which is concerned with sampling, specification, testing and with in the organisation, documentation and release procedures which ensure that the necessary and Incidental or relevant test are performed and the product is released for use only after ascertaining it's quality.
Question: What is GMP.?
Answer: It is part of quality assurance aim at ensuring that products are consistently manufactured to a quality appropriate to their intended use.
Question: What is standard operating procedures (SOPs).?
Answer: The detailed of written procedure that specify how a manufacturing, testing or administrative procedure is to be performed and an equipment is operated, maintained, calibrated and validated.
The SOPs are pertaining to various departments such as:
Question: What is specification.?
Answer: They are used to establish quality requirements for starting materials, components, solutions, cell bank, intermediate products, bulk and final products, labels etc.
Question: What is master formula.?
Answer: Master formula are the bank formats which describe each and every step of manufacturing process, which are to be filled at different stages of production process. The filled master formula containing the details of the production process are compiled in the form of batch production record.
Question: What is master plan.?
Answer: Strategic document that should state what is to be done, the scope of approach, the schedule of activities, and tasks to be performed. For example Validation master plan.
Question: What is quality manual.?
Answer: Written documents which is the sum of all that is necessary to implement and organisation's quality policy and meet quality objective. It includes organizational structure, responsibilities, procedures, systems, processes and resources etc.
Question: What is difference between Quality assurance and Quality control.?
Answer: Quality assurance: Quality assurance is the sum total of organized arrangements made with the object of ensuring that product will be the quality required by intended use.
All those planned or systematic action necessary to provide adequate confidence that a product will satisfy the requirements for quality.
Quality Control: Quality control is that part of GMP which is concerned with sampling, specification, testing and with in the organisation, documentation and release procedures which ensure that the necessary and relevant tests are carried out.
Operational laboratory techniques and fulfill the requirement of quality.