Remix education
pharmacy study material

Quality assurance (Unit:-5)

Calibration and Validation: Introduction, definition and general principles of
calibration, qualification and validation, importance and scope of validation,

types of validation, validation master plan. Calibration of pH meter,
Qualification of UV-Visible spectrophotometer, General principles of Analytical method Validation.
Warehousing: Good warehousing practice, materials management

• Analytical instruments are used for a specific analysis of drugs and
• So, regular performance verification are made to ensure that the instruments used
in the analytical purpose should be properly validated and calibrated “to
demonstrate that it is suitable for its intended purpose”.
1. Calibration
• Calibration is a process which ensures that an instrument or measuring
devices producing accurate results.
• Which are compared to the standard results.
• e.g. weigh balance, pH meter.
2. Validation
• It is a integral part of quality Assurance.
• Validation is a process of confirming that the instrument is installed correctly,
that it is operating effectively, and that it is performing without error in
documental evidence.
• It does not compared to standard results.
• Qualification is an act or process to assure something complies with some
conditions, standard or specific requirements.
• It is a part of validation.
• It is the action of proving that any equipment or process works correctly and consistently and produces the expected results.
PQ —— Qualification —— IQ
• Design Qualification
• Performance Qualification
• Installation Qualification
• Operational Qualification

• Calibration is the activity of checking, by comparison with a standard, the
accuracy of a measuring instrument of any type.
• It may also include adjustment of the instrument to bring it into
alignment with the standard.
• The validation of a test method is the process by which the relevance and
reliability of the method are assessed for a particular purpose.
• It is an essential stage in the evolution of the method from its development to its acceptance and application for regulatory purposes
“It is the action of proving and documenting that equipment or ancillary systems are properly installed, work correctly and actually lead to the
expected results. ”
• Validation assures a great importance for – Quality Assurance and cost reduction.
• Validation produces product fit for intended use. Quality; Safety and Effectiveness may be designed and built in to product.
• Validation is key element in assuming the quality of the product.
• Parameters controls determined the validation of any process or system.
• It helps to determine the worst case and risks that may arise during the
manufacturing of the quality products.
• Validation helps to investigate the deviations caused during the process.
• Deep study and understanding of the system and equipment are made possible due to the validation.
• The risk of the regulatory non-compliance is minimized after the validation.
• A validated process required less process control and the finished product testing.
• Batch to batch variation is minimized due to the validation of processes, systems and equipment.
• Reduces the production cost of the product.
• Increases the production of manufacturing facility due to the minimized rework and rejection.
• Decreases the chances of the failure of the batches.
• Assurance of quality
✓ Time bound
✓ Process optimization
✓ Reduction of quality cost.
✓ Minimal batch failures, improved efficiently and productivity.
✓ Reduction in rejections
✓ Increased output
✓ Fewer complaints about process related failures.
✓ Reduced testing in process and in finished goods.

✓ More rapid and reliable start-up of new equipment’s
✓ Easier maintenance of equipment
✓ Improved employee awareness of processes.
✓ More rapid automation.
✓ Government regulation (Compliance with validation requirements is
necessary for obtaining approval to manufacture and to introduce new
• A written report on the outcome to be produced.
• Validation over a period of time, e.g. at least three consecutive batches (full
production scale) ta demonstrate consistency.
• Process, materials and equipment to prove consistent yield of a product of the
required quality.
• Manufacturers to identify what validation work is needed
• Significant changes (facilities, equipment, processes) should be validated
• Risk assessment approach used to determine the scope and extent of validation needed.
• Analytical Test Methods
• Instrument Calibrations
• Process Utility Services
• Raw Material
• Equipment
• Facilities
• Product Design
• Cleaning
• Validation means rectification or confirmation
• Validation can be defined as a procedure that demonstrates that a process under standard conditions is capable of consistently producing a product that meets the established product specifications.
Types of Validation
The major types of Validation
• Process validation
• Cleaning validation
• Equipment validation
• Analytical method validation

As per FDA Nov.2008,
‘The collection of data from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality
Types of Process validation:
• Prospective Validation.
• Retrospective Validation.
• Concurrent Validation.
• Revalidation.
• Cleaning validation ensures that there is no cross contamination in a multi-
product manufacturing plant and also prevents microbial contamination.
• Once a product is manufactured, the equipment is cleaned using appropriate establish cleaning SOP’S established during IQ of the equipment
Types of contamination to be considered in cleaning validation
• Cross contamination
• Microbial contamination
• Contamination by cleaning or sanitizing agent
• Contamination by other agents
As per FDA. May 1987,
• Action of proving that any equipment works correctly and leads to the expected result is equipment qualification.
• It is not a single step activity but instead result from many discrete activities. Steps involved..
User requirement specification
1. Design qualification
2. Installation qualifications
3. Operational qualifications
4. Performance qualification