Types of validation

Types of validation:

1)Prospective validation
Establishing documented evidence that a device / process or system to do what  they do, on a pre-planned series of scientific investigations within the meaning of validation sets based Plan.

2)Concurrent validation
Is used when an existing process can be shown to be in a state of control by use of tests on samples taken at strategic points in a process, and at the end of the process. All data are collected simultaneously with the implementation of the process, to demonstrate sufficient information to process reproducibility.

3)Retrospective Validation
Establishing documented evidence that a process does not what it purports to do, based on review and analysis of historical data.

4)Revalidation:

It means repeating the original validation effort or any part of it, and includes investigate review of existing performance data.

Qualification:

Action of proving that any instrument or equipment works correctly and actually leads to the expected results. The word “validation” is sometimes widened to incorporate the concept of qualification. Types of qualification are:

Design Qualification (DQ)

 The first element of the validation of new facilities, systems or equipment could be design qualification (DQ).

Installation Qualification (IQ)

Installation qualification (IQ) should be performed on new or modified facilities, systems and equipment.

Operational Qualification (OQ)                

Operational qualification (OQ) should follow Installation qualification.
OQ is documented proof that operates the facilities provided in the above design, operation or approved acceptance range of equipment, as applicable.

Performance Qualification (PQ)

Performance qualification (PQ) should follow successful completion of Installation qualification and Operational qualification. The PQ documentation should be on standard manufacturing procedures and batch records and describe the methodology of sampling and testing to be.

VALIDATION PERFORMANCE CHARACTERISTICS:

SPECIFICITY: It is the ability to measure desired analyte in a complex mixture.

ACCURACY: It is the agreement between measured and real value.

PRECISION: It is the agreement between a series of measurements.

LINEARITY: It is the proportionality of measured value to concentration.

RANGE: It is the concentration interval where method is precise, accurate and linear.

DETECTION LIMIT: It is the lowest amount of analyte that can be detected.

QUANTITATION LIMIT: It is the lowest amount of analyte that can be measured or quantified.

ROBUSTNESS: Ability to remain unaffected by small changes in parameters.

RUGGEDNESS: Reproducibility under normal but variable laboratory conditions.

Standard curve:

                  A standard curve is a type of graph used as a quantitative research technique. Multiple samples with known properties are measured and graphed, which then allows the same properties to be determined for unknown samples by interpolation on the graph. The samples with known properties are the standards, and the graph is the standard curve. Standard curves are most commonly used to determine the concentration of a substance such as protein or DNA.

Quality Management

 A quality management system is comprised of quality planning and quality improvement activities, the establishment of a set of quality policies and objectives that will act as guidelines within an organisation, and QA and QC.

Quality Control:
“A part of quality management focused on fulfilling quality requirements”

Quality Assurance:
“A part of quality management focused on providing confidence that quality requirements will be fulfilled”

• QC is used to verify the quality of the output.
• QA is the process of managing for quality.

Quality control	Quality assurance
product	Process
reactive	Pro-active
Line function	Staff function
Find the defects	Prevent the defects
testing	Define process
performance	Monitoring

GMP and cGMP

·        GMP refers to Goods Manufacturing Practices that are guidelines followed by over 100 countries

·        GMP applies to pharmaceutical and healthcare products and help to maintain high standards in these products.

·        cGMP is to remind accepting countries that all guidelines must be followed with latest and current production processes.

·        cGMP is current goods manufacturing practices that need to be adhered to by participating countries.

GMP is also sometimes referred to as "cGMP". The letter "c" stands for "current," reminding manufacturers that they must employ technologies and systems that are up-to-date in order to comply with the regulation.

  Steps of GMP

·        Get the facility design right from the start

·        Validate processes

·        Write good procedures and follow them

·        Identify who does what

·        Keep good records

·        Train and develop staff

·        Practice good hygiene

·        Maintain facilities and equipment

·        Build quality into the whole product lifecycle

·        Perform regular audits

Buffer zone:

Buffer Zone in the simplest form, is an environment that separates the compounding room from the surrounding ambient (unrated) area and is to be constructed from low-particle-generating materials that can withstand continuous cleaning. ISO standards require that the buffer zone be maintained under positive pressure and that airborne particles be limited in compliance with ISO 8 requirements.

Hepa filter:

High-Efficiency Particulate Air Filters (HEPA Filters), are a form of extended surface media air filters previously known as High Efficiency Particulate Arrestors. A ’True’ HEPA filter must be at least 99.997% efficient - allowing no more than 3 particles in 10,000 to penetrate the filtration media.

HEPA Filters are used in Laminar flow hoods to provide maximum protection for products mixed in the laboratory or mixed and dispensed in the pharmacy. In order to ensure ongoing performance, these HEPA filtration devices must be correctly designed and regularly tested & re-certified by qualified personnel.